Pfizer/BioNTech say COVID-19 vaccine works against UK variant

Laboratory studies have confirmed that antibodies stimulated by Pfizer and BioNTech’s COVID-19 vaccine can neutralise the new, more transmissible variant of SARS-CoV-2 identified in the UK.

The results of the study – published online prior to peer review – are among the first data to indicate that any of the approved coronavirus vaccines can effectively target the mutated spike protein in the UK strain, known as B.1.1.7 lineage or VOC 202012/01.

According to the World Health Organization (WHO) the variant has now been seen in at least 60 countries worldwide. It is estimated to be somewhere between 50% and 70% more infectious than the original strain of SARS-CoV-2, but as yet there’s no evidence that it causes more severe COVID-19.

Pfizer and BioNTech previously showed that their BNT162b2 vaccine – now known as Comirnaty – was able to generate antibodies against one of the key mutations (N501Y) in the UK strain, which also appears in the South African variant, also raising concern worldwide.

VOC 202012/01 has an unusually high number of genetic changes however, with 10 mutations affecting the spike protein.

To test its activity further, Pfizer and BioNTech scientists created a non-replicating pseudovirus – featuring the full range of mutations in the UK strain’s spike protein – to test in the lab and found that BNT162b2 generated neutralising antibodies against it in the same range as seen with the unmutated virus.

“While the pseudovirus system used is a surrogate for authentic SARS-CoV-2, previous studies have shown excellent concordance between pseudotype neutralisation and SARS-CoV-2 neutralisation assays,” they said.

The paper suggests it is “unlikely” that the UK variant differs sufficiently from the original virus that recognition by neutralising antibodies generated by BNT162b2 will be affected, according to the authors.

“Unlike for influenza vaccines, the reduction in neutralisation that might indicate the need for a strain change has not been established for COVID-19 vaccines,” it goes on.

That is good news, but a less encouraging study has just been reported by South African researchers that the variant that was first discovered in their country – known as 501Y.V2 – does exhibit mutations that could make it evade immunity from a prior coronavirus infection.

The team led by Professor Penny Moore, from the National Institute for Communicable Diseases found that 48% of blood samples from 44 people who had been infected in the past did not show neutralising activity at all, while in the other half it was reduced.

That suggests that patients could get SARS-CoV-2 twice, but also that the current crop of vaccines may not be as effective. Once again, that study hasn’t yet been subjected to peer review.

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Single Covid vaccine dose in Israel ‘less effective than we hoped’

Surge in infections dampens optimism over country’s advanced immunisation programme

Israel’s coronavirus tsar has warned that a single dose of the Pfizer/BioNtech vaccine may be providing less protection than originally hoped, as the country reported a record 10,000 new Covid infections on Monday.

In remarks reported by Army Radio, Nachman Ash said a single dose appeared “less effective than we had thought”, and also lower than Pfizer had suggested.

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COVID-19 vaccine supplies in spotlight as immunisation campaigns kick in

Supplies of COVID-19 vaccines are in the spotlight as countries across the world step up their immunisation campaigns against the pandemic.

As vaccine manufacturers face unprecedented demand for their newly approved products, the race is on to provide enough shots for billions of people across the world.

Pfizer and BioNTech have responded to this by upgrading their manufacturing facility in Puurs, Belgium.

The companies said that this will result in a temporary reduction in the number of doses delivered in the upcoming week in the European Union.

Normal production will resume next week, while deliveries will increase from the week of 15th February.

This will allow the companies to deliver the quantities of vaccine doses the company has committed to in the first quarter and “significantly more” in the second quarter.

They will announce further updates about European vaccine supplies and the companies said they are planning to add more vaccine suppliers and contract manufacturers to boost worldwide capacity.

Meanwhile, the World Health Organization (WHO) has slammed the unequal distribution of coronavirus vaccines, where richer countries have been prioritised over poorer countries.

WHO director general Tedros Adhanom Gehbreyesus said in a briefing that vaccine policies had resulted in a “catastrophic moral failure”.

Over 39 million doses have been distributed across 49 high-income countries, but just 25 doses have been administered in only one of the lowest-income countries.

For those participants that did not want to take part in a clinical trial, reasons given included not knowing where to start looking for information as well as the COVID-19 pandemic, hesitance about traveling and not wanting to disrupt their medication plans.

Vaccines have been developed by companies based in China, India, Russia, the UK and the US, often with help from government funding.

Those countries have prioritised distribution to their own population, scrambling to place millions of orders with various manufacturers as the pandemic took hold last year.

Dr Tedros said this approach would result in increased prices and encourage hoarding.

He said: “I need to be blunt: the world is on the brink of a catastrophic moral failure – and the price of this failure will be paid with lives and livelihoods in the world’s poorest countries.”

“Ultimately, these actions will only prolong the pandemic, the restrictions needed to contain it, and human and economic suffering,” he added.

He called for a full commitment to the global vaccine-sharing scheme Covax, which is due to kick in next month.

More than 180 countries have signed up to the initiative, which is supported by the WHO and a group of vaccine advocacy group.

It will fund vaccinations for 92 low or middle-income countries and two billion doses are already on order.

In Europe, roll-out of COVID-19 vaccine has been criticised for being too slow.

Writing in the Guardian, Hans-Werner Sinn, professor of economics at the University of Munich, said that the EU had failed to buy enough shots of the Pfizer/BioNTech vaccine early in the pandemic because of “institutional inflexibility”.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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EU’s Covid vaccination debacle is down to institutional inflexibility

Supply delays underline there was no legal or economic justification for central planning

A storm is raging over the EU’s failure to have ordered more of the approved Covid-19 vaccines ahead of time. Stéphane Bancel, the CEO of the US pharmaceutical company Moderna, which gained approval for its vaccine shortly after Pfizer/BioNTech, claims that the EU has relied too much on “vaccines from its own laboratories”.

Did the European commission prioritise supporting its own pharmaceutical industry over protecting human lives? In fact, matters are not as simple as that. Contrary to what Bancel wants us to believe, the EU has actually ordered too little of its own vaccine. After all, the vaccine that is being administered most widely across the west was developed by a German company, BioNTech, and thus comes from the EU (though it was tested and partly produced in partnership with Pfizer in the US and with Fosun Pharma in China).

Related: The $2,000 stimulus cheques alone won’t work – the US needs better infrastructure

EU member states were wrong to entrust the European commission with the purchase of vaccines last summer

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Allergic reactions prompt Moderna COVID vaccine pause in California

Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic.

According to state epidemiologist Dr Erica Pan, there were a higher-than-expected number of suspected allergic reactions at a community clinic being used to administer the shot, with some people needing medical attention in a 24-hour period.

For now there is little information about the Moderna vaccine reactions, other than they are centred around a specific manufacturing lot – number 041L20A –  and that “fewer than 10” cases of allergic reactions were reported.

More than 330,000 doses from that lot have already been administered in California since the start of the vaccine roll-out, according to state department of public health. The clinic in question switched to another lot of Moderna vaccine after closing for a few hours.

There were also reports of allergic reactions during the initial roll-out of the Pfizer/BioNTech vaccine, including some cases of anaphylaxis, which also resulted in a temporary pause in dosing at some centres.

Last week, the Centers for Disease Control and Prevention (CDC) published new data which identified 21 cases of anaphylaxis after administration of a reported 1.9 million first doses of the Pfizer/BioNTech shot, mainly within 15 minutes of the injection.

That was equivalent to 11 cases per million doses, according to the agency, which says the reactions can be managed using patient screening for allergies, observation periods after dosing and having epinephrine injections on hand as a precaution.

Both the Pfizer/BioNTech and Moderna vaccines are based on mRNA and use an excipient – called polyethylene glycol (PEG) – that some scientists suggest could be responsible for the allergic reactions, according to a report in the journal Science.

“Our goal is to provide the COVID vaccine safely, swiftly and equitably,” said Dr Pan in a statement.

“Out of an extreme abundance of caution and also recognising the extremely limited supply of vaccine, we are recommending that providers use other available vaccine inventory and pause the administration of vaccines from Moderna lot 041L20A until the investigation by the CDC, FDA, Moderna and the state is complete.

While no vaccine or medical procedure is without risk, the risk of a serious adverse reaction is very small, according to the department. At last count, California had recorded almost 3 million COVID-19 cases, with just over 33,000 deaths, placing it among the worst affected states in the US.

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Fauci backs Biden’s plan for 100 million COVID-19 shots

A promise by president-elect Joe Biden to carry out 100 million coronavirus vaccinations in his first 100 days in power is “absolutely doable”, according to the US leading infectious diseases expert Dr Anthony Fauci.

Biden has announced ambitious initiatives to fight COVID-19 ahead of his inauguration, which is due to take place on Wednesday.

While Biden’s team acknowledges that it is a steep challenge, it’s received the backing of Fauci, who is optimistic that two new vaccines from AstraZeneca and Johnson & Johnson could be approved in the US in the next few weeks.

So far only 12 million people have received vaccines in the US.

This would add to the Pfizer/BioNTech and Moderna mRNA-based shots that already have emergency approval in the US.

The US has been severely affected by the pandemic, with figures recorded on Sunday morning showing 23,760,523 cases and 395,855 deaths had been recorded by Johns Hopkins University in the US.

Fauci, director of the US-government funded National Institute of Allergy and Infectious Diseases (NIAID), told NBC’s Meet the Press that “it’s going to take a while to turn this around.”

He added: “I can tell you one thing that’s clear is that the issue of getting 100 million doses in the first 100 days, is absolutely a doable thing.”

Biden can invoke the Defense Production Act to boost supplies of the vaccine, Fauci added.

“But the feasibility of his goal is absolutely clear, there’s no doubt about it. That can be done.”

On the vaccines from J&J and AZ, Fauci said: “I would imagine within a period of a week or so, or at the most a couple of weeks, they’re going to be getting their data together and showing it to the [FDA].

“They’re going to have to get their data and safety monitoring board to look at it to see if it is appropriate to start, you know, essentially putting the package together to get an Emergency Use Authorization. But we’re weeks away, not months away, for sure.”

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UK to face short term delay in delivery of Pfizer vaccine

Overall number of doses delivered between January and March will remain the same, the firm says

The UK is set to face short-term delays in delivery of the Pfizer/BioNTech coronavirus vaccine as the pharmaceutical company upgrades its production capacity.

Pfizer is upscaling production at its plant in Puurs, Belgium, in efforts to produce more doses than originally planned for 2021 – temporarily reducing deliveries to all European countries.

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PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria

Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment

Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, Advance Personalized Fertility Treatment

Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China

Published: Jan 15, 2020 | Tags: Henlius’, HLX15 (biosimilar, daratumumab), Receives, IND, Approval, Multiple Myeloma in China

Abbott to Launch NeuroSphere myPath App to Record Pain Relief in Chronic Pain Patients

Published: Jan 15, 2020 | Tags: Abbott, Launch, NeuroSphere myPath App, to Record Pain Relief in Chronic Pain Patients

Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma in Children And Young Adult

Published: Jan 15, 2020 | Tags: Pfizer’s, Xalkori (crizotinib), Receives, US FDA’s, Approval, ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

 Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies

Published: Jan 15, 2020 | Tags: Takeda, KSQ, Collaborate, Develop, Commercialize, Novel Immuno-Oncology Therapies

BeiGene’s Tislelizumab (BGB-A317) + CT Receive NMPA’s Approval as 1L Therapy for Advanced Squamous NSCLC

Published: Jan 14, 2020 | Tags: BeiGene, Tislelizumab, (BGB-A317), CT, Receive ,NMPA, Approval ,1L Therapy, Advanced Squamous NSCLC

Sanofi Signs a License Agreement with Biond for BND-22

Published: Jan 14, 2020 | Tags: Sanofi, Signs, License Agreement, Biond, BND-22

Celltrion Report Results of CT-P59 in P-II/III Study for COVID-19

Published: Jan 14, 2020 | Tags: Celltrion, Report, Results, CT-P59, P-II/III, Study, COVID-19

ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV

Published: Jan 14, 2020 | Tags: ViiV Healthcare, Tivicay, dolutegravir, dispersible tablets, Receives, EMA, Approval, Children, HIV

Amgen Collaborates with Evoq to Develop Novel Therapies for Autoimmune Disorders

Published: Jan 14, 2020 | Tags: Amgen, Collaborates, Evoq, Develop, Novel Therapies, Autoimmune Disorders

Kamada to Commercialize Three Biosimilar Products in Israel

Published: Jan 14, 2020 | Tags: Kamada, Commercialize, Three Biosimilar, Israel

The US Government to Purchase Additional Doses of Regeneron’s Casirivimab and Imdevimab to Combat COVID-19

Published: Jan 13, 2020 | Tags: US, Government, Purchase, Additional Doses, Regeneron, Casirivimab, Imdevimab, COVID-19

Teladoc Health and Dexcom Offers CGM-Powered Insight for T2D

Published: Jan 13, 2020 | Tags: Teladoc Health, Dexcom, Offers, CGM-Powered, T2D

UCB Launches Nile AI as a Digital Health Company to Transform the Course of Epilepsy

Published: Jan 13, 2020 | Tags: UCB, Launches, Nile AI, Digital Health Company, Transform, Course of Epilepsy

Bayer Reports the US FDA’s Acceptance of NDA and Grants Priority Review for Finerenone (BAY 94-8862) to Treat CKD and T2D
Published: Jan 13, 2020 | Tags: Bayer, Reports, US, FDA, Acceptance, NDA, Priority Review , Finerenone, (BAY 94-8862), CKD, T2D

Gilead Collaborates with VIR to Evaluate Combination Therapy for Chronic Hepatitis B Virus

Published: Jan 13, 2020 | Tags: Gilead, Collaborates, VIR, Evaluate, Combination Therapy, Chronic Hepatitis B Virus

GSK and VIR Biotechnology to Evaluate VIR-7832 in the Early Treatment of COVID-19

Published: Jan 12, 2020 | Tags: GSK and VIR, Biotechnology, Evaluate, VIR-7832, Early Treatment, COVID-19

Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC

Published: Jan 12, 2020 | Tags: Roche, Reports, Updated OS Data, Tecentriq, Avastin, P-III, IMbrave150 Study, Unresectable HCC

AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer

Published: Jan 12, 2020 | Tags: AstraZeneca, Collaborates, Adaptive, Mapping, Immune Response, Cancer

Bluebird bio to Spin Off its Oncology Business into Independent Company

Published: Jan 12, 2020 | Tags: Bluebird bio, Spin Off, Oncology Business, Independent Company

Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio

Published: Jan 12, 2020 | Tags: Novartis, In-Licenses, BieGene, Tislelizumab, Oncology Portfolio

 Biogen and Apple Collaborate to Launch Virtual Study on Cognitive Decline

Published: Jan 12, 2020 | Tags: Biogen, Apple, Collaborate, Launch, Virtual Study, Cognitive Decline

BMS Collaborates with ArsenalBio to Advance Next-Generation T cell Therapies for Solid Tumors

Published: Jan 11, 2020 | Tags: BMS, Collaborates, ArsenalBio, Advance, Next-Generation, T cell Therapies,  Solid Tumors

Chi-Med and Inmagene Collaborate to Develop Therapies for Immunological Diseases

Published: Jan 11, 2020 | Tags: Chi-Med, Inmagene, Collaborate, Immunological Diseases

Sanofi to Acquire Kymab for ~$1.45B

Published: Jan 11, 2020 | Tags: Sanofi, Acquire, Kymab, ~$1.45B

BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A

Published: Jan 11, 2020 | Tags: BioMarin, Reports, Results, Valoctocogene Roxaparvovec, P-III, GENEr8-1 Study, Hemophilia A

Roche’s Xofluza Receives the EC’s Approval for the Treatment of Influenza

Published: Jan 11, 2020 | Tags: Roche, Xofluza, Receives, EC, Approval, Treatment, Influenza

AbbVie Reports Results of Skyrizi (risankizumab) in P-III Induction Studies for Crohn’s Disease

Published: Jan 11, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (risankizumab), P-III, Induction Studies, Crohn’s Disease

Related Post: PharmaShots Weekly Snapshot (Jan 4-8, 2020)

The post PharmaShots Weekly Snapshots (Jan 11 – 15, 2021) first appeared on PharmaShots.

J&J single-shot COVID-19 vaccine shows early promise

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month.

The UK has caused controversy in recent weeks by tinkering with the dosing regimens for coronavirus vaccines from AstraZeneca and Pfizer/BioNTech, which are being rolled as part of the country’s mass vaccination programme.

Both of these vaccines require two doses, as does the most recently approved shot from Moderna, which is due to arrive in the UK in the spring.

In order to make the best use of scarce vaccine resources the UK has opted to extend the time between doses to up to 12 weeks, a strategy that has been criticised by some scientists who are fearful that it could cause vaccine-tolerant strains of the virus to emerge.

Johnson & Johnson’s Janssen pharma unit is further behind in the development of its vaccine, which has the crucial advantage of being administered in a single shot.

The UK government has an order of 30 million doses of the vaccine from J&J and an option for an additional 22 million doses in an agreement signed last summer.

Latest data give hope that the vaccine could be added to the campaign after phase 1/2a data showed that the shot provided an immune response that lasted for at least 71 days, the duration of time measured in the study involving patients aged 18-55 years.

The phase 1/2a interim analysis showed that the Company’s COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants.

Data demonstrated that, after a single vaccination, neutralising antibodies against COVID-19 were detected in over 90% of study participants at day 29 and 100% of participants aged 18-55 years at day 57.

These neutralising antibodies remained stable through day 71, currently the latest timepoint available in this ongoing study.

Data on durability of immune responses in trial participants aged over 65 years will be available in late January and longer-term follow-up to one year is planned.

Top line data from a phase 3 study is due later this month, although this timing may change due to disease events.

J&J expects to file with the FDA first, followed by other regulators. The European Medicines Agency is conducting a rolling review of the vaccine to speed up the process.

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Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

Shots:

  • The approval is based on the ADVL0912 study assessing Xalkori in 121 patients aged 1-21yrs. that included 26 patients with r/r, systemic ALK+ ALCL prior treated with at least one systemic treatment
  • The study showed 88% ORR. Among 23 patients, who achieved a response, 39% maintained their response for at least 6mos. and 22% maintained their response for at least 12mos.
  • Xalkori is a TKI and has received the FDA’s BTD for ALK+ ALCL in May’2018. Additionally, EMA has agreed to a PIP for the therapy to treat pediatric patients with r/r systemic ALK+ ALCL

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: The Bangkok Post

The post Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult first appeared on PharmaShots.

PharmaShots’ Key Highlights of Fourth Quarter 2020

  • The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter
  • Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated the review for AZ’s COVID-19 vaccine. Meanwhile, AZ’s AZD1222 met its primary endpoint in preventing COVID-19
  • Our team at PharmaShots has summarized and complied with the insights of Q4’20

Sanofi Launches Tetraxim (DTaP-IPV) for Preschoolers in India

Date – Oct 01, 2020

Product – Tetraxim

  • Sanofi’s Tetraxim combines four vaccines into one and provides protection against four diseases – Diphtheria, Pertussis, Tetanus and Polio. The launch reduces the number of injections, increases comfort, and improves vaccination compliance for children
  • Booster vaccines are designed to boost the immunity acquired during prior vaccination. With the launch, Sanofi currently protects school children in 100+ countries, with 63M doses distributed globally
  • Tetraxim (DTaP-IPV) is a 4-in-1 booster vaccine and the only inactivated poliomyelitis containing combination vaccine in India that has full-dose antigenic strength of Diphtheria, Tetanus and acellular Pertussis (whooping cough) for preschoolers

BioMarin Receives the US FDA’s Approval Allowing Maximum Dose of 60mg with Palynziq (pegvaliase-pqpz) for PKU

Date – Oct 08, 2020

Product – Palynziq (pegvaliase-pqpz)

  • The US FDA has approved the sBLA to increase the maximum allowable dose of 60mg with Palynziq for PKU. Previously, the maximum dose was 40mg
  • The label expansion is based on OLE study out to 3yrs. demonstrating that 66% had a blood Phe level ≤360 μmol/L consistent with the Phe target ACMG recommended guidelines @2yrs. of treatment and 50% had blood Phe levels ≤120 μmol/L @2yrs. 75%, 66% & 48% had a blood Phe ≤600, 360, and 120 μmol /L, respectively @3yrs. of treatment
  • Additional, safety data with over 6yrs. of follow up remains consistent with the previous safety profile of Palynziq irrespective of dose. Moreover, BioMarin has dosed the first participant in the global Phearless P-I/II study of BMN 307 for PKU

AbbVie Reports Results of Skyrizi (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis

Date – Oct 08, 2020

Product – Skyrizi (risankizumab)

  • The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study
  • Results: ~63% of patients with moderate to severe plaque psoriasis treated with SKYRIZI achieved completely clear skin for 172 wks., as measured by 100% improvement from baseline in the PASI 100. New results from the P-III LIMMitless study were presented at the 29th EADV Virtual Congress
  • Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. It is part of a collaboration between Boehringer Ingelheim & AbbVie, with AbbVie leading development & commercialisation globally

Regeneron Seeks the US FDA’s EUA for REGN-COV2 Antibody Combination to Treat COVID-19

 Date – Oct 09, 2020

 Product – REGN-COV2

  • Regeneron has submitted a request to the US FDA seeking EUA for its REGN-COV2 investigational Ab regimen to treat COVID-19. If EUA is granted, the US govt. has committed to making REGN-COV2 available in the US at no cost and would be responsible for its distribution
  • The company reported that there are doses available for ~50,000 patients and expects to have doses available for 300,000 patients in total within the next few months
  • REGN-COV2 is a combination of two mAbs, REGN10933 & REGN10987, designed to block the infectivity of SARS-CoV-2. The company reported that a single 8g dose of REGN-COV2 was given to President Donald Trump following a compassionate-use request from doctors as part of a treatment regimen

Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

 Date – Oct 29, 2020

 Product – BI 764198

  • The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission
  • The therapy has shown a reduction in cellular damage and lung edema in preclinical studies and may provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 was well tolerated in P-I study in healthy adults
  • BI 764198 is potent & selective inhibitor of TRPC6, focusing to reduce the need for ventilator support and to improve patient recovery rate

Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the treatment of Unresectable Hepatocellular Carcinoma

Date – Oct 30, 2020

Product – Tecentriq + Avastin

  • The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a cohort of Chinese patients (n=194) from the same study
  • Results: Tecentriq in combination with Avastin reduced the risk of OS by 56% (among Chinese patients) and 42% (global results) & the PFS risk by 40% (among Chinese patients) and 41% (global results) as compared with sorafenib
  • IMbrave150 is the 1st P-III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Additionally. in May 2020, the US FDA approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy

Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s Keytruda (pembrolizumab) in Patients with Various Cancers

 Date – Oct 30, 2020

 Product – Keytruda

  • Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors
  • In preclinical studies, THOR-707 demonstrated the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as a single agent as well as in combination with an anti-PD1 mAb
  • THOR-707 is currently being evaluated by Sanofi in an ongoing P-I dose escalation and expansion trial assessing THOR-707 and determining its recommended P-II dose alone and in combination with anti-PD-1 and anti-EGFR antibodies

Janssen Reports Results of Tremfya (guselkumab) in Interim Analysis of P-II GALAXI 1 study for Moderately to Severely Active Crohn’s Disease

 Date – Oct 30, 2020

  Product – Tremfya

  • The P-II GALAXI 1 study involves assessing of Tremfya vs PBO in patients with mod. to severely active CD with intolerance to conventional therapies. In interim analyses, patients were randomized equally into 5 arms, with Tremfya (200/600/1200 mg (IV) @0, 4 & 8wks. respectively or with ustekinumab, dosed at ~6mg/kg (IV) @0wk. and dosed 90 mg (SC) @8wks. or PBO
  • @12wks. (Tremfya vs PBO), reductions in CDAI (154.1, -144.3, -149.5 vs -36.0); patients achieving clinical remission vs PBO (CDAI<150): (54.0%, 56.0%, 50.0% vs 15.7%); clinical remission among conventional therapy failures & among patients who had previously failed biologic therapy, (61.6% vs 18.5% & 45.5% vs 12.5%) respectively
  • @12wks, Tremfya induced greater improvement across key clinical and endoscopic outcome measures, with a safety profile consistent with approved indications. Tremfya is a mAb that selectively binds to the p19 subunit of (IL)-23 and inhibits its interaction with the IL-23 receptor

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Date – Nov 02, 2020

Product- BNT162b2

  • Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI
  • The MHRA’s decision is based on a rolling submission, including data from the P-III study, demonstrating 95% efficacy in participants without & with/ out prior SARS-CoV-2 infection, in each case measured from 7 days after the second dose
  • This marks the first EUA following a WW P-III trial of a vaccine to combat the pandemic. The companies are anticipating further regulatory decisions across the globe in Dec’2020

AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M

Date – Nov 02, 2020

Product- Crestor

  • Grünenthal to acquire EU rights (Ex- Spain and the UK) of Crestor & its associated brands for ~$350M and will take over bulk production and packaging by 2025. The deal is expected to be closed in Q1’21
  • The payments will be made in two tranches: $320M will be paid upon transaction closing and $30M as additional milestones
  • Crestor is a statin, a lipid-lowering agent used to treat blood-lipid disorders & to prevent CV events, such as heart attacks & strokes, and is approved as a lipid-regulating medicine in 100+ countries

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Date – Nov 02, 2020

Product- Xolair

  • The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively
  • Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs -0.2); no new or unexpected safety signals were identified respectively
  • Xolair is the first biologic for the treatment of nasal polyps that targets and blocks IgE. In the US, Novartis & Genentech work together to develop and co-promote Xolair

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Date – Nov 03, 2020

Product – CT-P17(biosimilar,adalimumab)

  • The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
  • Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
  • Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre- filled syringe (PFS)

AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

Date – Nov 03, 2020

Product – FPI-1434

  • Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
  • The collaboration leverages Fusion’s TAT platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of Abs and cancer therapies, including DDRis
  • Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s FPI-1434) and AstraZeneca’s therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets

Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

Date – Nov 03, 2020

Product- HMR59

  • Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy
  • The acquisition will boost Janssen’s eye disease portfolio & strengthens its gene therapy capabilities
  • HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent further damage to the retina and preserve vision. The P-I study of the therapy for patients with geographic atrophy is completed while the P-I study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate the long-term safety

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasi

Date – Nov 04, 2020

Product- Deucravacitinib

  • The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis
  • The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of deucravacitinib was consistent with previously reported P-II results
  • Deucravacitinib (BMS-986165, PO) is the first & only novel selective TYK2 inhibitor, currently being evaluated in psoriasis, PsA, lupus, and IBD

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Date – Nov 04, 2020

Product- amivantamab

  • The BLA is based on the P-I CHRYSALIS study assessing amivantamab as a monothx. and in combination with lazertinib in adult patients with advanced NSCLC
  • The company has established an EAP for patients in the US who may be eligible to obtain access to mivantamab during the review of the BLA
  • Amivantamab is an EGFR & MET bispecific Ab with the immune cell-directing activity that targets tumors with activating & resistance to EGFR & MET mutations & amplifications. Amivantamab has received the US FDA’s BTD in Mar’2020

Merck to Acquire VelosBio for $2.75B

Date – Nov 05, 2020

Product- VLS-101

  • Merck will acquire all the outstanding shares of VelosBio for $2.75B in cash. The transaction is expected to be closed by the end of 2020
  • The acquisition will bolster Merck’s oncology pipeline with the addition of VelosBio’s VLS-101, which is an investigational ADC targeting ROR1 to treat hematological malignancies and solid tumors
  • In Oct’2020, VelosBio has initiated P-II study to evaluate VLS-101 for the treatment of patients with solid tumors, including patients with TNBC, HR+/HER2+ BC, and NSCLC. Additionally, VelosBio is developing a preclinical pipeline of ADCs and bispecific Abs targeting ROR1 to complement VLS-101 by offering alternative methods of tumor cell killing

Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design

Date – Nov 05, 2020

Product- N/A

  • Iktos will leverage its de novo generative design technology to be used in a structure-enabled context, facilitating the rapid & cost-effective design of Merck KGaA’s drug discovery program
  • The collaboration follows the previous agreement of the companies signed in 2019. Merck KGaA is utilizing Iktos’ de novo design software platform Makya for MPO
  • Iktos’ AI technology is based on deep generative models that help bring speed & efficiency to the drug discovery process by automatically designing virtual novel molecules having desired activities for treating a disease

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Date – Nov 05, 2020

Product- NVX-CoV2373

  • Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community
  • The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per individual, administered 21 days apart.
  • NVX-CoV2373 is evaluated in P-ll trial in the UK and 2 ongoing P-ll studies that began in Aug’2020, a P-llb trial in SA, and a P-l/ll continuation in the US and Australia. Additionally, Novavax has multiple agreements for the supply of NVX-CoV2373 directly to the US, UK, Canada, and through partnerships, supply to Japan, South Korea, and India

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Date – Nov 07, 2020

Product- Hemlibra

  • The 4 pivotal HAVEN studies (HAVEN-1, 2, 3, 4) included pooled data from 401 people with hemophilia A with/ out factor VIII inhibitors, with a median duration efficacy period of 120.4wks.
  • Hemlibra maintained low treated bleed rates with ABR remaining low throughout the evaluation period at 1.4. The proportion of participants who experienced 0 treated bleeds (70.8-83.7%) increased with each consecutive 24wks. period
  • Roche also presented the first interim analysis of the EUHASS database suggesting that the safety profile of Hemlibra in the real-world setting is consistent with the clinical trials, with no new/ emerging safety signals. Hemlibra is a bispecific factor IXa- and factor X-directed Ab

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Date – Nov 09, 2020

Product – CT-P59

  • The P-I clinical trial involves assessing CT-P59 (20/40/80 mg/kg) vs PBO in 18 patients with mild symptoms of SARS-COV-2 infection who were randomized into 3 cohorts
  • Results: patients demonstrated a 44% reduction in mean clinical recovery time, while no patients required hospitalization or antiviral therapy
  • Celltrion has submitted the IND application for the clinical trial globally & plans to conduct global P-II & P-III trials including Korea. Additionally, Celltrion has also initiated a post-exposure prophylaxis study assessing CT-P59 as a protective treatment, by investigating the efficacy of the treatment in those who have been in contact with confirmed SARS-CoV-2 infected patients

AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia

Date – Nov 10, 2020

Product- Calquence (obinutuzumab)

  • The approval is based on P-lll ELEVATE-TN study assessing Calquence + obinutuzumab or Calquence alone vs obinutuzumab + CT in patients with previously untreated CLL and ASCEND study assessing Calquence vs rituximab + idelalisib/ bendamustine in patients with r/r CLL
  • ELEVATE-TN results: a reduction in the risk of disease progression or death (90% and 80%). ASCEND results: patients remained alive and free from disease progression @12mos. (88% vs 68%)
  • Calquence is a selective inhibitor of BTK, binds covalently to BTK, thereby inhibiting its activity. The approval follows CHMP’s recommendation received in Jul’2020

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Date – Nov 12, 2020

Product- Abrocitinib

  • The P-lll JADE REGIMEN study involves assessing of Abrocitinib (100/ 200mg) vs PBO in 1233 patients aged ≥ 12 yrs. in a ratio (1:1:1) with mod. to sev. AD following response to initial open-label induction treatment with abrocitinib (200mg)
  • Result: The study met its 1EPs i.e. probability of not experiencing a flare @52wks. (81.1%, 57.4% vs 19.1%) and 2EPs i.e. patients maintain an IGA response of clear or almost clear relative
  • Following an initial 12wks. induction treatment phase, fewer patients experienced a flare at any point in the trial @40wks. Abrocitinib is a JAK inhibitor, which modulates multiple cytokines involved in the pathophysiology of AD, including IL-4, IL-13, IL-31, IL-22, and TSLP

UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

Date – Nov 13, 2020

Product – Handl Therapeutics

  • The acquisition will bolster UCB’s pipeline program, capabilities, and platforms in the gene therapy space. The Handl Therapeutics will continue to be based in Leuven, Belgium while working closely with UCB’s international research teams
  • In addition, the UCB collaborated with Lacerta to focus on CNS diseases, under which Lacera will lead research, preclinical activities, and the early manufacturing process development, while UCB will complete IND-enabling studies, manufacturing, and clinical development
  • The collaboration will allow UCB to access Lacerta’s expertise in AAV-based CNS targeted gene therapies, fortifying UCB’s ability to produce effective treatments for neurodegenerative diseases

Henlius report the NMPA’s Acceptance of HLX15(biosimilar, Daratumumab) to treat multiple myeloma

Date – Nov 16, 2020

Product- HLX15  

  • The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment
  • The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
  • The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products

Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2

Date – Nov 20, 2020

Product- BNT162b2

  • collaborate to focus at developing & commercializing transformative therapies in Greater China. Both the companies will leverage their clinical development, regulatory and commercial expertise
  • Pfizer will contribute ~$70M of non-dilutive capital toward in-licensing & co-development. At LianBio’s discretion, products will be presented to Pfizer for joint development
  • Pfizer will have a right of first negotiation to obtain commercial rights to jointly developed assets & each company will carry separate financial considerations. Additionally, Pfizer may provide in-kind support for marketing, development & regulatory activities

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Date – Nov 23, 2020

 Product – AZD1222

  • Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported
  • One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose of at least 1 mos. apart & another dosing regimen showed 62% efficacy when given as 2 full doses at least 1 mos. apart. The combined analysis from both dosing regimens resulted in the efficacy of ~70%
  • AZ will plan regulatory submission of the data across the globe and will seek an Emergency Use Listing from the WHO for an accelerated pathway to vaccine availability in low-income countries.

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer

Date – Dec 15, 2020

Product- Cobas PIK3CA Mutation Test

  • Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark
  • The IVT test is a real-time PCR test for the qualitative detection & identification of 17 mutations in exons 2, 5, 8, 10 & 21 in the gene encoding the catalytic subunit of PIK3CA in DNA isolated from FFPET and is intended to identify patients with m-BC harboring mutations
  • This test reports automated results, with flexible throughput to process 30 samples/ run on the widely available cobas z 480 analyzers. The test can detect 17 mutations in the PIK3CA gene and can help clinicians to identify patients who may benefit from PI3K targeted therapy

Abbott’s COVID-19 IgG Quantitative Antibody Blood Test Receives CE Mark

Date – Dec 16, 2020

Product- SARS-CoV-2 IgG II Quant test

  • Abbott received CE Mark for its new quantitative SARS-CoV-2 IgG lab-based serology test. The test measures levels of IgG Abs to help in the evaluation of a person’s immune response
  • The study to determines the clinical performance of Abbott’s SARS-CoV-2 IgG II Quant test on its Alinity i instrument showed that it had 99.60% specificity & 99.35% sensitivity in patients tested 15 days or more after symptoms began
  • The test will be available on both the Abbott ARCHITECT and Alinity i platforms. Abbott plans to submit its test for US FDA’s EUA imminently

Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

Date – Dec 15, 2020

Product- COVID-19 vaccine

  • Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use
  • Following an agreement to supply 20M of doses for the Government of Canada, AstraZeneca seek out Health Canada’s clearance in Oct’2020, leading to data submission done on a rolling basis for accelerating the review process
  • Health Canada is looking to give Canadians access to COVID-19 vaccines asap without compromising its safety, efficacy, and quality standards

Related Post: PharmaShots’ Key Highlights of Third Quarter 2020

The post PharmaShots’ Key Highlights of Fourth Quarter 2020 first appeared on PharmaShots.

Tivicay approved in Europe in new dispersible tablet for children with HIV

ViiV’s Tivicay is to become available in Europe in a new dispersible tablet form to treat children living with HIV.

The joint venture, majority-owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders, said the European Commission had granted a marketing authorisation for the new formulation.

These tablets are used in combination with other antiretroviral agents for treatment of human immunodeficiency virus type-1 infection in paediatric patients.

To be eligible, children must be at least four weeks of old, weighing at least 3kg and must not have been treated with an integrase inhibitor, although it doesn’t matter whether they have been treated with other drugs classes.

This authorisation includes updated dosing recommendations, for Tivicay (dolutegravir) film-coated tablets (10mg, 25mg and 50mg) for children six years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands.

Approval is based on data from the ongoing P1093 and ODYSSEY studies, which are being conducted in collaboration with international paediatric research networks.

P1093 is a a safety, tolerability and dose finding registrational study in paediatric patients aged four weeks to 18 years being conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) network in the USA, Brazil, Thailand, South Africa, Zimbabwe, Kenya and Tanzania.

ViiV Healthcare, the Division of AIDS (DAIDS) at the US National Institutes of Health (NIH) are collaborating in this trial.

ODYSSEY is a randomised control efficacy trial in first and second- line treatment, in paediatric patients aged four weeks to 18 years being conducted by the PENTA network in Europe, South America, Thailand, Uganda, Zimbabwe, and South Africa.

Originally designed to support World Health Organization (WHO) guideline recommendations by WHO weight bands, this study will now also provide data to support revised dosing and continue to 96 weeks.

ViiV Healthcare, the Paediatric European Network for Treatment of AIDS (Penta) and the Medical Research Council (MRC) Clinical Trials Unit at University College London for ODYSSEY are collaborating in this trial.

The post Tivicay approved in Europe in new dispersible tablet for children with HIV appeared first on .

Hackers posted stolen COVID-19 vaccine info online, says EU regulator

Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update.

The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records.

Since then the agency has been investigating the incident involving the theft of documents that formed part of BioNTech’s filing for the BNT-162b vaccine.

In its latest statement, the EMA said that the investigation “revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines belonging to third parties have been leaked on the internet.”

The EMA added that “necessary action is being taken by the law enforcement authorities.”

It gave no further details about where the documents were posted, adding that further information will be provided “in due course” as the investigation continues.

The EMA said its regulatory framework remains fully functional and timelines relating to review and approval of COVID-19 medicines and vaccines are not affected.

Just days before the EMA hack emerged in mid-December, analysts from IBM warned that a phishing campaign had targeted organisations involved with the cold chain needed to keep vaccine supplies moving.

The operation began in September and spanned six countries and looked like the work of an unnamed “nation-state”, the analysts said in a blog post.

While individual cyber criminals would be unlikely to profit from the information they argued that “advanced insight into the purchase and movement of a vaccine that can impact life and the global economy is likely a high-value and high-priority nation-state target.”

Sam Curry, chief security officer at Cybereason, said that the actions were “diabolical” but added that bringing the perpetrators to justice would be “more fantasy than reality.”

Curry added that hackers see COVID-19 data as a “valuable asset” and will continue to do so for the “foreseeable future.”

He added: “Kudos to the pharma and research companies for working with law enforcement agencies to face these threats head on with advanced cyber tools and improved security hygiene.

The hackers “are well funded and are looking to reap both financial and political fame,” Curry added.

“As the protection surface expands to mobile, the cloud and other potential attack vectors, those companies that can detect a breach quickly and understand as much as possible about the hacking operation itself, will be able to stop the threat and minimise or eliminate the risk all together.”

Feature image copyright BioNTech SE 2020, all rights reserved

The post Hackers posted stolen COVID-19 vaccine info online, says EU regulator appeared first on .

Netanyahu touts Pfizer deal after 20% of Israelis get Covid jab

Country will share data on its rapid vaccination campaign as ‘global model’, says PM

One in five Israelis have been given first doses of coronavirus vaccines, roughly ten times higher than the UK and US, with the country aiming to have inoculated all eligible age groups within two months.

Israel’s lighting-fast vaccine campaign had been expected to slow down this week as the first batches of Pfizer/BioNTech doses ran low.

Related: Palestinians excluded from Israeli Covid vaccine rollout as jabs go to settlers

Continue reading…

EU plans video summit after doubling supply of Pfizer Covid vaccine

Bloc agrees deal for a further 300m doses as hopes are raised for speedier rate of inoculations

EU leaders are to hold a pandemic video summit on 21 January after the bloc said it had reached a deal with Pfizer and BioNTech for 300m more doses of their Covid-19 vaccine, giving the EU nearly half the firms’ global output for 2021.

The move raised hopes for speedier inoculation across the continent as the European regulator, which this week approved the Moderna shot, said it would authorise six doses from each vial of the BioNTech/Pfizer vaccine, increasing available jabs by 20%.

The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.

Continue reading…

PharmaShots Weekly Snapshot (Jan 4-8, 2020)

Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies

Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies

Sarepta Reports Mixed Results of SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) in Part 1 of Study 102 for DMD   

Published: Jan 7, 2020 | Tags: Sarepta, Reports, Mixed Results, SRP-9001, (rAAVrh74.MHCK7.micro-dystrophin), Part 1, Study 102, DMD

PerkinElmer to Acquire Oxford Immunotec for ~$591M

Published: Jan 7, 2020 | Tags: PerkinElmer, Acquire, Oxford Immunotec, ~$591M

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD

Published: Jan 7, 2020 | Tags: Pfizer, Reports, First, Patients, Dosing, of PF-06939926 in P-III CIFFREO Study for DMD

Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy

Published: Jan 7, 2020 | Tags: Alnylam, Reports, Results, Vutrisiran, P-III, HELIOS-A, Study, Patients, hATTR Amyloidosis, Polyneuropathy

Bayer Collaborates with CureVac for CVnCoV Against COVID-19

Published: Jan 7, 2020 | Tags: Bayer, Collaborates, CureVac, CVnCoV, Against, COVID-19

Hologic to Acquire Biotheranostics for ~$230M

Published: Jan 7, 2020 | Tags: Hologic, Acquire, Biotheranostics, ~$230M

Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology

Published: Jan 6, 2020 | Tags: Pfizer, Signs, License, Supply, Agreement, ImaginAb, CD8 ImmunoPET Technology

Merck KGaA Acquires AmpTec to Strengthen its mRNA Capabilities for Vaccines, Treatments and Diagnostics

Published: Jan 6, 2020 | Tags: Merck KGaA, Acquires, AmpTec, Strengthen, mRNA, Capabilities,  Vaccines, Treatments, Diagnostics

Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies

Published: Jan 6, 2020 | Tags: Genentech, Signs, ~$1B, Pact, Ribometrix, Develop, RNA-Targeted, Small Molecule Therapies

Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy

Published: Jan 6, 2020 | Tags: Astellas, Reports, US, FDA, Acceptance, Priority Review, NDO Therapy, Myrbetriq, mirabegron, tablets, oral suspension

Pfizer Collaborates with Dewpoint to Develop Therapies for Rare Form of Muscular Dystrophy

Published: Jan 6, 2020 | Tags: Pfizer, Collaborates, Dewpoint, Develop, Therapies, Rare Form of Muscular Dystrophy

 Nirmidas Receives the US FDA’s EUA for its COVID-19 Rapid Antibody Fingerstick Test    

Published: Jan 6, 2020 | Tags: Nirmidas, Receives, US, FDA, EUA, COVID-19, Rapid, Antibody, Fingerstick Test

AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Priority Review for Chronic Kidney Disease

Published: Jan 6, 2020 | Tags: AstraZeneca, Farxiga, (dapagliflozin), Receives, US, FDA, Priority Review, Chronic Kidney Disease

AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis

Published: Jan 5, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (Risankizumab), P-III, Studies, Active Psoriatic Arthritis

Regenxbio Reports the Initiation of First Pivotal Program for RGX-314 to Treat Wet AMD

Published: Jan 5, 2020 | Tags: Regenxbio, Provide, Update, RGX-314, Treat, Wet AMD, RGX-202

Evotec Receives Milestones in its Neurodegeneration Collaboration with BMS

Published: Jan 5, 2020 | Tags: Evotec, Bristol Myers Squibb, $6M, Milestones

Stryker Acquires OrthoSensor and its Knee Surgery Sensor Technology

Published: Jan 5, 2020 | Tags: Stryker, Acquires, OrthoSensor, Knee Surgery Sensor Technology

Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development

Published: Jan 4, 2020 | Tags: ViGeneron, Signs, Global License Agreement, Biogen, Ophthalmic Gene Therapy, Development

 Y-Biologics Signs a License Agreement with 3D Medicines for YBL-013 in the Territory of Greater China

Published: Jan 4, 2020 | Tags: Y-Biologics, signed, License Agreement, 3D Medicines, Develop, Manufacture, Commercialize, YBL-013

aTyr Reports Results of ATYR1923 in P-ll Study for COVID-19 Patients with Severe Respiratory Complications

Published: Jan 4, 2020 | Tags: aTyr Pharma, Report, Positive Results, ATYR1923, P-ll Study, COVID-19

Genentech’s Tiragolumab + Tecentriq Receive the US FDA’s Breakthrough Therapy Designation for PD-L1-High Non-Small Cell Lung Cancer

Published: Jan 5, 2020 | Tags: Genentech, Tiragolumab + Tecentriq, Receives, US FDA’s, Breakthrough Therapy Designation, PD-L1-High Non-Small Cell Lung Cancer

Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

Published: Jan 4, 2020 | Tags: Pfizer, OPKO, Reports, US FDA, Acceptance, BLA, Somatrogon, Treat, Growth Hormone Deficiency (GHD)

 Hologic to Acquire Somatex for ~$64 M   

Published: Jan 4, 2020 | Tags: Hologic, Acquire, Somatex, $64 M

Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D  

Published: Jan 3, 2020 | Tags: Provention Bio, Reports, Submission, BLA, Priority Review, US, FDA, Teplizumab, Prevent, T1D

Oura Ring Monitors Body Temperature and Identify Early COVID-19 Symptoms

Published: Jan 2, 2020 | Tags: Oura Ring Monitors, Body Temperature, Identify, Early, COVID-19, Symptoms

Tiziana Completes Clinical Trial of Nasally Administered Foralumab for COVID-19 in Brazil

Published: Jan 3, 2020 | Tags: Tiziana, Completes, Clinical Trial, Nasally, Administered, Foralumab, COVID-19, Brazil

 Antengene Reports NDA Submission for ATG-010 (Selinexor) to Treat RRMM and RR DLBCL in South Korea     

Published: Jan 3, 2020 | Tags: Antengene, Reports, NDA, Submission, ATG-010, (Selinexor), RRMM, RR DLBCL, South Korea

AstraZeneca’s COVISHIELD Receives EUA in India for COVID-19

Published: Jan 4, 2020 | Tags: AstraZeneca, COVISHIELD, Receives, EUA in India

RedHill Reports Results of Yeliva (opaganib) in P-II Study for COVID-19

Published: Jan 3, 2020| Tags: RedHill, Reports, Results, Yeliva, (opaganib), P-II, Study, COVID-19

Related Post: PharmaShots Weekly Snapshots (Dec 28- 31, 2020)

The post PharmaShots Weekly Snapshot (Jan 4-8, 2020) first appeared on PharmaShots.

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD

Shots:

  • The first patient has been dosed in P-III CIFFREO study assessing PF-06939926 vs PBO in 99 ambulatory male patients aged 4-7yrs. with DMD across 55 sites in 15 countries.
  • The first patient was dosed at a site in Barcelona, Spain on Dec 29, 2020. The 1EPs of the study is the change in NSAA @1yr, while patients will be followed in the CIFFREO study for 5yrs. after treatment with PF-06939926
  • PF-06939926 is an investigational rAAV9 capsid carrying a shortened version of the human dystrophin gene (mini-dystrophin) under the control of a human muscle-specific promotor and has received the US FDA’s FT designation in Oct’2020 and ODD & RPD in May’2017

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Wall Street Journal

The post Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD first appeared on PharmaShots.

Pfizer/BioNTech vaccine may work against new virus mutation, scientists say

The Pfizer/BioNTech vaccine appears to work against an important mutation in the new coronavirus variants causing havoc in the UK and South Africa, according to research from the drugs giant.

Findings of the lab study posted online have not yet been peer reviewed but provide some reassurance for countries like the UK, which are relying on vaccines to bring the pandemic under control.

Pfizer joined with scientists from the University of Texas Medical Branch to conduct the study, which indicated the vaccine was effective at neutralising virus with the mutation known as N501Y.

The mutation is responsible for greater transmissibility and there have been concerns it may also allow the virus to dodge the immune response produced as a result of the vaccination.

The study team tested blood taken from people who had received the mRNA vaccine developed by BioNTech and Pfizer.

However, findings are limited because it does not look at all mutations found in the new variants of the virus.

Pfizer’s chief scientific officer Philip Dormitzer noted that the vaccine has been found to work against 15 other mutations that the company has previously tested against.

He told Reuters: “So we’ve now tested 16 different mutations and none of them have really had any significant impact. That’s the good news.”

However he warned that this “doesn’t mean that the 17th won’t (have an impact)”.

He is also concerned about another mutation found in the South African variant, called E484K.

Researchers plan to run similar tests to check if the vaccine works against this and other mutations found in the UK and South African variants.

The advantage of the Pfizer/BioNTech vaccine is that it can be quickly tweaked to address any new mutations, and according to Reuters the changes could be made in as little as six weeks.

It’s not clear how the changes to the virus affect the rival vaccines developed by AstraZeneca/Oxford University and Moderna.

The post Pfizer/BioNTech vaccine may work against new virus mutation, scientists say appeared first on .

Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses.

When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

After months of turbulent lockdown measures, the dawn of approved vaccinations signalled hope COVID-19 could finally be under control.

Sadly, the chaos is continuing as the UK grapples with the emergence of a new variant of SARS-CoV-2, estimated to be up to 70% more transmissible than the previous form of the virus.

As cases surge, the UK’s decision to delay second doses of the vaccine beyond the 3-4 weeks tested and approved during Phase III clinical trials is causing widespread concern. Many believe the strategy is too risky – prioritising political expediency over science and using the British public as laboratory subjects during an already severe crisis.

The advice, which first came from the UK’s Joint Committee on Vaccination and Immunisation (JCVI), stated a maximum interval of 12 weeks should take place between the first and second doses of both Pfizer and AstraZeneca’s vaccines.

JCVI said this is likely to have a greater public health impact in the short term and reduce the number of preventable deaths from COVID-19.

“The rate of vaccine delivery in the UK is currently limited by vaccine supply rather than by workforce capacity,” said the committee.  “An extended interval between vaccine doses together with initial prioritisation of the first vaccine dose would increase the flow of vaccine supply in the short term. This will allow for more first doses to be delivered to more people earlier.”

The advice has been endorsed by the UK’s four chief medical officers but has been met with backlash from the medical community. Many healthcare workers have aired grievances on Twitter protesting the changes.

The British Medical Association (BMA) also blasted the decision as “unreasonable and totally unfair”.

“The Government must see that it’s only right that existing bookings for the oldest and most vulnerable members of our society are honoured, and it must also as soon as possible publish a scientifically-validated justification for its new approach,” said the BMA.

“As doctors, we believe this can and should be done even as practices and the wider NHS step up the COVID-19 vaccination programme to deliver initial doses of vaccination to other vulnerable people, including frontline healthcare professionals – many of whom still have not even received their first vaccination.”

‘Erosion of public trust’’

The NHS Confederation, which represents leaders across the organisation, told pharmaphorum the government needed to be very clear in its communications with the public about exactly what they are being asked to do and why.

“We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorised dosing schedule for each COVID-19 vaccine”

“Protecting frontline staff from infection is vital to help them care for patients with COVID, as well as delivering the vaccination programme,” said NHS Confederation director Layla McCay.  “However, there has been concern about changes to the vaccination schedule, which were announced at short notice and led to confusion and anxiety for patients and could lead to an erosion of public trust in healthcare providers. As always, NHS teams will pull out all the stops to respond to changing guidance, but the government must do more to explain the rationale for this change.”

Internationally, the decision has been met with scepticism. The FDA issued a statement regarding dosing schedules on 4 January 2021. “We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccines to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.

“We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.”

In a joint statement Pfizer and BioNTech warned there was no data to demonstrate that protection after the first dose is sustained after 21 days. “The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design,” said the companies.

Industry support

The Oxford-AstraZeneca vaccine trial did include difference spacing between doses and showed longer gaps (two to three months) yielded a greater immune response. The combined trial results published in the Lancet showed that vaccine efficacy 14 days after a second dose was higher in the group that had more than six weeks between the two doses (65.4%) than in the group that had less than six weeks between doses (53.4%).

Andrew Pollard, head of the Oxford Vaccine Group and chief trial investigator vaccine told the BMJ that extending the gap between doses made sense.

“Generally, a longer gap between vaccine doses leads to a better immune response, with the second dose causing a better boost. (With HPV vaccine for girls, for example, the gap is a year and gives better responses than a one-month gap.) From the Oxford vaccine trials, there is 70% protection after the first dose up to the second dose, and the immune response was about three times greater after the second dose when the second dose was delayed, comparing second dose after four weeks versus second dose after two-three months.”

Akiko Iwasaki, professor of immunobiology at Yale Medical school also tweeted support for the changes, stating the new SARS-CoV-2 variant as the deciding factor.

 

“I am still a proponent of two-dose vaccine but given the urgency, we can delay the seconnd dose until more vaccines become available. I know many others have been saying this all along, but it was the B.1.1.7 variant transmission rate that did it for me,” said Iwasaki.

David Grainger, chief scientific advisor at life sciences investment firm Medicix, also expressed confidence in the strategy, referring to modelling by the University of Toronto that predicts increasing the number of people protected, by limiting individuals to a single dose, reduces severe COVID events (ICU stays and death) by between 30-40% over a 6-month period. This could amount to over 20,000 lives saved.

“The vaccine only must be 50% effective in two people to reduce the overall risk of infection that is achieved with 95% protection in one person,” said Grainger. “If I protect 10,000 people out of a population of 20,000 with 1% risk of infection at 95% efficacy, I get five cases from the protected subgroup and 95 cases in the unprotected subgroup for a total of 100 infections; if I protect all 20,000 people with 50% efficacy, again I get 100 infections. The existing data strongly suggests that a single dose will deliver at least 50% protection for at least a few months.”

He added that during the pandemic, decisions often needed to be made in the absence of proper data. “It teaches us that we cannot just ‘follow the science’ because that pathway is way too conservative (at least if that means only do things for which there is clear, direct evidence).

“This is why we should have scientific advisors, but not rely on scientists to make decisions. It is why scientists rarely make good investors or businessmen – too many decisions need to be made in the absence of much information.”

The post Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy appeared first on .

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules.

With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to bring the virus under control.

The UK is in a national lockdown that could last into March, with more than 62,000 new cases and 1,000 coronavirus-related deaths recorded yesterday as a more transmissible strain threatens to overwhelm the country’s health service.

As things stand, the two rival mRNA-based vaccines from Pfizer/BioNTech and Moderna are now approved for use in the EU.

Meanwhile in the UK, the Pfizer/BioNTech and AstraZeneca shots have been quickly approved.

The UK government has an order for just 7 million shots of the Moderna vaccine covering just half a percent of the population, while the European Commission has secured 160 million doses, enough to cover around 18% of the population.

US-based Moderna said that first deliveries of the vaccine in Europe will begin next week.

Moderna’s vaccine is arguably the most effective approved so far at around 95%, while AstraZeneca’s rival that has been swiftly approved in the UK ahead of Europe works in around 62% of cases when given its recommend dose.

The Pfizer/BioNTech seems to be of comparable efficiency to the Moderna shot, and is being rolled out across the UK along with the AZ vaccine.

There is evidence to suggest the AZ vaccine’s efficacy could be improved to 90% by giving a half-dose to start with, but UK regulators have not been given sufficient evidence to approve this formulation.

After a rolling review began of Moderna’s vaccine late last year, the European Commission has issued a conditional marketing authorisation the day after it was backed by regulators from the CHMP scientific committee.

Moderna has said it is in talks with the UK regulator over approval, where European Commission decisions on medicines no longer automatically apply because of Brexit.

Under Brexit transition arrangements the Medicines and Healthcare products Regulatory Authority (MHRA) will continue to adopt decisions by the European Commission on medicines.

In usual circumstances companies are required to submit an identical filing request to the MHRA after a CHMP positive opinion

The UK regulator would then follow the decision of the European Commission, which nearly always rubber-stamps the CHMP’s decision within a few weeks.

But on this occasion the process has not been possible because of the accelerated timelines for vaccine approval because of the pandemic.

Questioned by pharmaphorum, the MHRA was unable to comment on arrangements for the Moderna vaccine at the time of writing.

However Moderna said separately that it is in talks with the MHRA to get the vaccine approved.

 

 

 

The post UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine appeared first on .

Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology

Shots:

  • ImaginAb to receive license fees and payments for manufacturing and other support and will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials
  • ImaginAb will provide technical, clinical & regulatory support to Pfizer
  • The collaboration follows the pre-competitive alliance b/w ImaginAb, Pfizer and other global companies focusing on the development of 89Zr CD8 ImmunoPET technology, signed in Oct 14, 2019

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PRNewswire

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Pfizer deal paves way for approval of ImaginAb’s cancer imaging tech

ImaginAb has signed a deal with Pfizer, which it hopes will help it to gather information necessary for approval of its tumour imaging agent as a medical device in markets in the US and other countries.

The California-based company has signed a non-exclusive license with Pfizer to supply its 89Zr CD8 Immuno-PET agent, which can be used to image CD8 T cells in cancer patients.

Used with widely available PET scan technology, ImaginAb’s technology allows doctors to track the T-cell immune response to cancer in real time and it has already picked up a multi-party deal involving Pfizer, AstraZeneca and Takeda.

The latest deal builds on that arrangement in 2019 and while the financial deals are not disclosed, chief executive officer Ian Wilson told pharmaphorum it involves an up-front fee plus payments each time the treatment is manufactured for use.

The company argues that its technology, based on specially engineered antibody fragments, can give an accurate map of T-cell activity, giving a more representative picture of how the tumour is responding to an immunotherapy.

Information of this kind can make or break a cancer trial, giving guidance about whether a tumour is growing or has become swollen because of an incursion by T-cells.

Big pharma is catching on to the idea as companies try to find ways to determine whether immunotherapies are working and avoid expensive trial failures.

“They are looking for effective tools that allow them to read out quicker and faster and better than current methodologies,” said Wilson, who said trials have failed or been delayed because of issues with conventional invasive biopsies.

“(The technology) allows them to make decisions quicker and allows them to triage their drugs more quickly in the clinical phase.”

Equally important to the company is the safety data gathered as the technology is used as the pharma companies use it to guide development of cancer immunotherapies.

This could lead to an approval in the coming years by regulators such as the FDA, where the technology could be used as a guide by doctors to indicate whether a course of immunotherapy is working, or if another option should be used.

Wilson counts US biotech CellSight as its only direct competitor with equivalent technology, although this seems to be considerably further away from commercial use by big pharma.

“From a health economic payer point of view (our technology) allows everyone to rationalise and improve patient care,” said Wilson.

 

The post Pfizer deal paves way for approval of ImaginAb’s cancer imaging tech appeared first on .

Pfizer Collaborates with Dewpoint to Develop Therapies for Rare Form of Muscular Dystrophy

Shots:

  • Dewpoint to receive up front payment and up to $239M as research, development & commercial milestones along with royalties on sales of the therapies
  • The companies collaborated for the development of therapies to treat DM1
  • The companies will collaborate their expertise to advance the novel therapeutic solutions addressing the patients’ needs

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Business Wire

The post Pfizer Collaborates with Dewpoint to Develop Therapies for Rare Form of Muscular Dystrophy first appeared on PharmaShots.

Pfizer drops the blue pill, kicks off 2021 with new DNA logo

Pharma companies are always talking about moving ‘beyond the pill’, and Pfizer’s new brand identity embodies that – it’s decades old pill-like logo has been replaced with a DNA double helix that it says reflects its commitment to breakthrough science.

The logo – which retains the company’s traditional blue colour scheme – has been more than 18 months in the making and according to the company it is “unlocking the pill to reveal Pfizer’s DNA: the power of science.”

It’s likely no coincidence that Pfizer’s flagship project in 2020 while the design of the logo was being finalised was unquestionably its high-profile alliance with BioNTech on the RNA-based coronavirus vaccine Comirnaty, which provided further evidence of the potential of harnessing genetic toolkits to tackle health issues.

In fact, one wag on Twitter compared the time taken to come up with logo to the mere seven months Pfizer and BioNtech needed to bring their COVID-19 vaccine through clinical testing:

Another took issue with the orientation of the helix part of the logo, claiming it overlooks some basic scientific principles.

Pfizer has also been changing a lot in the last few years, moving away from being a diversified healthcare company covering branded human and animal medicines, generics and consumer health products to one focused on novel therapies.

Last year, it exited generics – which had been a drain on profit – after combining its Upjohn unit with Mylan to form Viatris. It’s also in the process of offloading consumer health into a joint venture with GlaxoSmithKline and several years ago spun out its animal health assets into standalone company Zoetis, so as to concentrate on higher-margin, innovative drugs.

The logo also “signals [a] shift from commerce to science”, according to an explanation on Pfizer’s website, but retains the same tagline as its predecessor: “Breakthroughs that change patients’ lives.”

A Wall Street Journal article notes that Pfizer surveyed more than 4,000 patients and 2,000 doctors across multiple countries, and held 12 internal focus groups, before deciding on the new design.

“Our new identity reflects the dignity of Pfizer’s history and captures the innovative spirit and science focus alive in the company today,” said Sally Susman, Pfizer’s executive vice president and chief corporate affairs officer.

The post Pfizer drops the blue pill, kicks off 2021 with new DNA logo appeared first on .

No data to support UK delay of vaccines’ second dose, says WHO

Move to postpone second jab by up to 12 weeks is not supported by scientific evidence, experts find

There is no scientific evidence for a delay of more than six weeks in administering the second dose of the Pfizer/BioNTech vaccine against Covid, say experts from the World Health Organization.

The UK is planning to postpone giving the second dose of both the Pfizer/BioNTech and the Oxford/AstraZeneca vaccines by up to 12 weeks – twice the length of time for which there is data, according to the WHO.

Continue reading…

Pfizer/ OPKO Health’s Somatrogon; FDA EU for SCONE device; Antengene ATG-010 for rrMM and rrDLBCL; SanBio STEMTRA Phase 2 Interim Results

Pfizer and OPKO Health: A step closer to FDA Nod for pediatric growth hormone deficiency (GHD) drug, Somatrogon

Pfizer and Opko had joined hands in 2014 to develop somatrogon, a pediatric growth hormone deficiency (GHD) drug. It comprises the natural sequence of growth hormone and a copy of the C-terminal peptide (CTP) from the beta chain of human chorionic hCG at the N-terminus and two copies at the C-terminus, which helps in extending the half-life of the molecule. 

The drug had already been rewarded with Orphan Drug designation by the US FDA and EU for the treatment of children and adults with growth hormone deficiency. Growth hormone deficiency (GHD) is a condition that arises due to the lack of enough growth hormone in the body. It can be due to a damaged pituitary gland or another gland called the hypothalamus. 

Recent results from Phase III clinical studies support the duo’s regulatory submission for somatrogon. The US FDA has accepted the initial Biologics License Application submission for the therapy with the target action date for an FDA decision is October 2021. Somatrogon is going to compete with already established Pfizer’s Genotropin, a recombinant human growth hormone, however, the latter one puts a burden on the patients due to its daily injections, which also leads to compliance issues in children. 

FDA Emergency Use Authorization for SCONE Medical’s Novel Aerosol Infection Containment Device

SCONE Medical Solutions Inc. (SMS) has collaborated with Mayo Clinic to fight the battle against infectious diseases. The idea is to provide protection to healthcare workers taking care of infected patients during Aerosol Generating Procedures (AGPs), particularly in the acute care/triage setting.

As a pre-gift of the new year, the companies received the Emergency Use Authorization from the FDA for the SCONE device. As the whole world is busy fighting the infectious disease that keeps on re emerging and mutating, SCONE is building a future that is safer due to its effective substitute to manage the aerosol transfer among different patients and employees. 

The doublet is working together on developing SCONE, a small capacity, disposable device. It leverages the negative pressure to vacuum out aerosols emitted around a patient’s head and neck, thereby cushioning with an extra layer of “active” barrier protection for healthcare workers while treating potentially infectious patients. Easily portable and disposable, the device provides an added advantage. 

Antengene Files for NDA for ATG-010 (Selinexor) in South Korea for rrMM and rrDLBCL

Antengene Corporation has submitted a New Drug Application (NDA) with Orphan Drug Designation (ODD) to the South Korean Ministry of Food and Drug Safety (MFDS) for ATG-010 (selinexor, XPOVIO) in combination with low dose dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (rrMM)

Furthermore, the company has also gone forward for the filing for the NDA of ATG-010 as monotherapy to treat adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL).

The submissions came after the positive results of the pivotal STORM and SADAL studies that demonstrated significant and meaningful efficacy with a manageable safety profile for ATG-010. ATG-010 is a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE). It is the first FDA-approved to be used for the treatment of both multiple myeloma and diffuse large B-cell lymphoma. 

Currently, Antengene is conducting two registrational Phase 2 clinical trials of ATG-010 in China for rrMM (MARCH) and for rrDLBCL (SEARCH). The drug has already received orphan drug designation in South Korea in October 2020. Its US partner, Karyopharm received FDA approval for the treatment of patients with multiple myeloma after at least one prior therapy on December 18, 2020.

SanBio Publishes the Results of STEMTRA Phase 2 Interim Analysis for SB623 in Neurology

SanBio Group recently publicized the interim analysis of SB623 Phase 2 clinical “STEM cell therapy for TRAumatic brain injury” (STEMTRA) trial in an online issue of Neurology, the medical journal of the American Academy of Neurology. 

STEMTRA was a Phase 2, randomized, double-blind, surgical sham-controlled, global trial aimed at investigating the efficacy and safety of SB623 compared to sham surgery in patients with stable chronic neurological motor deficits secondary to traumatic brain injury (TBI)

The trial managed to achieve the primary efficacy endpoint of significant improvement from baseline of Fugl-Meyer Motor Scale (FMMS) score at six months for SB623-treated patients. While secondary endpoints did manage to improve from baseline but were not statistically significant versus control

The results of the STEMTRA trial have opened new doors in the chronic brain dysfunction domain, a relatively difficult area for drug development. However, several start-up companies have taken initiative to advance the therapeutic landscape in the field. 

The post Pfizer/ OPKO Health’s Somatrogon; FDA EU for SCONE device; Antengene ATG-010 for rrMM and rrDLBCL; SanBio STEMTRA Phase 2 Interim Results appeared first on DelveInsight Business Research.

Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

Shots:

  • The BLA submission is based on P-lll study assessing the safety and efficacy of Somatrogon (0.66 mg/kg, qw) vs Somatropin (0.034 mg/kg, qd) in 224 pediatric patients in the ratio of (1:1) with GHD
  • The study met its 1EPs of non-inferiority as measured by annual height velocity @12mos.; least square mean (10.12 vs 9.78 cm/year); the treatment difference in height velocity was 0.33 cm/yr
  • The anticipated PDUFA date is Oct 2021 and is approved, the therapy is served as a once-weekly treatment option

Click here ­to­ read full press release/ article | Ref: Business Wire | Image: The Wire

The post Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency first appeared on PharmaShots.

Analysis: is it wise for England to mix and match Covid vaccines?

US experts warn against plan to give different second jab if supplies run low

The UK is setting the pace around the world in the approval and use of Covid vaccines but, while other countries watch intently, not all are yet prepared to embrace what looks like public health pragmatism rather than strict adherence to evidence.

Britain is the first country in the world to approve and use the Oxford/AstraZeneca vaccine, just as it was first with Pfizer/BioNTech’s. In a further trailblazing decision, it is giving everyone a first shot of either of those vaccines, with the second shot delayed to 12 weeks afterwards instead of the three- or four-week interval in the trials.

Continue reading…

Change in vaccine policy is a high-stakes gamble | Letters

The effectiveness of delaying the second dose of Covid vaccines must be carefully monitored, argues Dr Grizelda George, while Jan Mortimer and Jenny van Tinteren fear the move will increase distrust and uncertainty

The manufacturer of the Pfizer/BioNTech vaccine has said its efficacy has only been assessed for two doses given three weeks apart. Therefore the idea that a single dose will be protective beyond three weeks is speculative (Covid vaccine: chief medical officers defend rescheduling of second doses, 31 December). It would be truly tragic to vaccinate millions of recipients with the Pfizer/ BioNTech vaccine (at considerable effort and financial cost) with a twelve-week gap between doses if this doesn’t give them protection.

It is worth noting that there is likely to be a correlation between the antibody response and protection from infection. Therefore volunteers who have already completed two doses could be asked to give a small sample of blood to check the level of neutralising antibodies present four weeks from the first dose. Recipients whose second dose has been postponed after 4 January could give a similar sample from 11 January onwards to check their levels at the four-week point. A relatively small number of volunteers (perhaps 20 or 30 in each group) might settle this.

Continue reading…

BioNTech criticises EU failure to order enough Covid vaccine

Firm races to fill potential gap left by bloc’s gamble on several vaccines being approved

BioNtech has criticised the EU’s failure to order more doses of its coronavirus vaccine, saying it is now racing with its US partner Pfizer to boost production amid fears of a European “gap” left by the lack of other approved vaccines.

The Pfizer/BioNTech vaccine was the first to be approved by the bloc late last month, after being accepted by the UK, Canada and the US. They and other countries have also since approved the Moderna or Oxford/AstraZeneca vaccine, leaving the EU trailing behind.

Continue reading…

PharmaShots Weekly Snapshots (Dec 28- 31, 2020)

Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study

Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, results, Sinopharm

Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis

Published: Dec 28, 2020 | Tags: CysticFibrosis, Drug, New, reports, Submission, Treatment, Trikafta, Vertex

The US FDA Grants EUA for Quanterix’s Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test

Published: Dec 29, 2020 | Tags: Emergency Use Authorization, Grants, Quanterix’s Simoa, Semi-Quantitative SARS-CoV-2 IgG Antibody Test, Us FDA

Sorrento Reports Submission of MAA to COFEPRIS for COVI-STIX Rapid Detection Test

Published: Dec 30, 2020 | Tags: COFEPRIS, Marketing Authorization Application, reports, Sorrento, Submission

Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

Published: Dec 30, 2020 | Tags: AstraZeneca, Authorization, COVID-19, Health Canada, reports, Statement, UK, vaccine

Incyte Collaborates with Cellenkos for CK0804 to Treat Myelofibrosis

Published: Dec 30, 2020 | Tags: Cellenkos, CK0804, Development, Global, Incyte, License Agreement, Myelofibrosis, Signs

Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D

Published: Dec 24, 2020 | Tags: Clinical, Data, Nod, P-I/II, P-III, Seeks, Start, Submits, Trial, Trials, ZyCoV-D, Zydus Cadila

Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen

Published: Dec 29, 2020 | Tags: antibody, Cocktail, COVID-19, Data, Encouraging, flow, Hospitalized, Initial, Low, Oxygen, patients, Regeneron, reports, Trial

AstraZeneca’s AZD1222 Receives MHRA’s Emergency Supply Authorization in the UK

Published: Dec 30, 2020 | Tags: AstraZeneca, Authorization, AZD1222, Emergency, MHRA, receives, Supply, UK

Skyhawk Collaborates with Vertex to Discover and Develop Novel Small Molecules Modulating RNA Splicing for Serious Diseases

Published: Dec 22, 2020 | Tags: Develop, Discover, License Agreement, Novel Small Molecules for Serious Diseases, Sign, Skyhawk, Strategic Research, Vertex

Novo Nordisk Reports Submission of Label Extension Application to the EMA for Semaglutide (once weekly, 2.0 mg) for T2D

Published: Dec 29, 2020 | Tags: EMA, Label Extension, Novo Nordisk, reports, Semaglutide, Submission, T2D

Chi-Med Initiates Rolling Submission of NDA to the US FDA of Surufatinib to Treat Advanced Neuroendocrine Tumors

Published: Dec 28, 2020 | Tags: Advanced, Chi-Med, Initiates, NDA, Neuroendocrine, Rolling, Submission, Surufatinib, Treat, Tumors, Us FDA

Alligator Bioscience Submits CTA for the P-II OPTIMIZE-1 Study of Mitazalimab

Published: Dec 28, 2020 | Tags: Alligator Bioscience, CTA, Mitazalimab, OPTIMIZE-1, P-II, study, Submits

Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

Published: Dec 28, 2020 | Tags: Acceptance, Lorbrena (lorlatinib), Pfizer, Priority Review, Report, sNDA, treat (ALK)-Positive (NSCLC), US FDA’s

Biocon has Launched Tacrolimus Capsules in the US

Published: Dec 28, 2020 | Tags: Biocon, Launches, Tacrolimus Capsules, US

Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix in Oncology and Women’s Health

Published: Dec 28, 2020 | Tags: Agreement, Commercialize, Develop, health, Myovant, Oncology, Pfizer, Relugolix, Signs, Women

Janssen Report MAA Submission of Amivantamab to EMA for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Published: Dec 28, 2020 | Tags: Amivantamab, EGFR Exon 20 Insertion Mutations, EMA, Janssen, MAA, Metastatic Non-Small Cell Lung Cancer, Report, Submission

Zai Lab Signs an Exclusive License Agreement with Cullinan Oncology for the Development and Commercialization of CLN-081 in Greater China

Published: Dec 28, 2020 | Tags: CLN-081, Commercialization, Cullinan Oncology, Development, Exclusive License Agreement, Greater China, Signs, Zai Lab

Algernon’s Last Patient Out in NP-120 (Ifenprodil) P-IIb/III Study for COVID-19

Published: Dec 24, 2020 | Tags: Algernon, COVID-19, Ifenprodil, Last Patient Out, Multinational, P-IIb, P-IIb/III, reports

Casi and Juventas Cell Therapy’s CNCT19 (CD19 CAR-T) Receives China NMPA’s BT Designation for Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Published: Dec 24, 2020 | Tags: (CD19 CAR-T), Breakthrough Therapy Designation, BT Designation, Casi, CNCT19, NMPA, receives, Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Amyrt’s AP103 Receives the US FDA’s Orphan Drug designation for Dystrophic Epidermolysis Bullosa (DEB)

Published: Dec 23, 2020 | Tags: Amyrt’s, AP103, Dystrophic Epidermolysis Bullosa (DEB), receives, Treatment, US FDA’s

Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

Published: Dec 24, 2020 | Tags: Agreement, Aurobindo, Commercialize, COVAXX, COVID-19, Develop, India, Pharma, Sign, UB-612, UNICEF, vaccine

Innovent’s Byvasda (Bevacizumab Biosimilar) Receive NMPA’s Approval for Adult Recurrent Glioblastoma

Published: Dec 28, 2020 | Tags: Adult Recurrent Glioblastoma, approval, BYVASDA (Bevacizumab Biosimilar) Treatment, Innovent, NMPA

Innovent’s Sulinno (Adalimumab biosimilar) Receives China’s NMPA Approval for Pediatric Plaque Psoriasis and Non-infectious Uveitis

Published: Dec 23, 2020 | Tags: Adalimumab Biosimilar, Innovent, NMPA’s Approval, Non-infectious Uveitis, panuveitis in adults, Pediatric Plaque Psoriasis, posterior uveitis, Receive, Sulinno

Related Post: PharmaShots Weekly Snapshots (Dec 21-23, 2020)

The post PharmaShots Weekly Snapshots (Dec 28- 31, 2020) first appeared on PharmaShots.

Questions hang over UK’s rollout of Oxford/AstraZeneca jab

Analysis: regulator surprises by approving 12-week gap between first and second shots of vaccine as well as Pfizer/BioNTech shot

It’s a pragmatic solution to an incredibly urgent problem – how to immunise very large numbers of people at risk from a rampaging variant of Covid-19 in the shortest possible time. The answer that government advisers have come up with is to give them all – more than 20 million of them – a single shot of the Oxford/AstraZeneca vaccine so that they have some protection and postpone the second dose to three months afterwards, when hopefully there will be plenty of vaccine available for boosters.

Related: How well does the Oxford vaccine work? What we know so far

Related: The vaccine miracle: how scientists waged the battle against Covid-19

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AZ COVID-19 vaccine cleared in UK, dosing to start next week

The UK has approved AstraZeneca and Oxford University’s COVID-19 vaccine AZD1222 in another significant step forward in the fight against the pandemic, with first doses due to be administered on Monday.

The UK government has already ordered 100 million doses of the adenovirus-based shot, enough to vaccinate 50 million people, adding to the 40 million dose order of the Pfizer/BioNTech shot – now known as Comirnaty – that was approved earlier this month.

The UK is the first country to approved AZD1222, and AZ says it is preparing to provide “millions of doses” in the first quarter of 2021, while building capacity for three billion doses for delivery worldwide by the end of the coming year.

The emergency approval comes as millions more people in the UK are facing tighter lockdown restrictions after another daily record of more than 53,000 confirmed new coronavirus cases yesterday.

Health Secretary Matt Hancock warned that while the rollout of AZD1222 brings forward the end of the pandemic, mass vaccination will take time and people should “hold their nerve” to avoid swamping the NHS in the first few months of 2021.

He told the BBC this morning that he now has “a high degree of confidence that we can be out of this by the spring.”

The Joint Committee on Vaccine and Immunisation (JCVI) has set out priority groups who will receive the vaccine, and as with the Pfizer/BioNTech jab first in line will be the over-80s and health and social care workers. So far, more than 600,000 people have received Comirnaty since dosing started on 9 December.

AZ chief executive Pascal Soriot said that millions of doses of AZD1222 have already been produced and are being filled, ready to ramp up supply as the UK immunisation programme gathers pace.

Soriot confirmed that AZ should be able to provide enough vaccine to meet the UK government’s target of a million doses per week “very rapidly” with the first doses due to be delivered to clinics “today or tomorrow.”

He also said that AZD1222 provides a reasonable level of protection from the coronavirus after a single dose, and as the second dose only needs to be given within 12 weeks, that provides an opportunity to immunise more people, more quickly.

In turn, that should start to reduce mortality and hospitalisation from COVID-19 and ease pressure from the NHS as cases continue to surge.

The AZ vaccine can also be stored, transported and handled at normal refrigerated conditions for at least six months making it more suitable for delivery to parts of the world with less sophisticated healthcare systems than the Pfizer/BioNTech shot, which requires colder storage.

Soriot also reiterated his view that AZD1222 should provide protection against the new, more transmissible strain of the SARS-CoV-2 virus that causes COVID-19.

The first case of that has now been identified in the US, along with dozens of other countries, but new research suggests that while it is easier to transmit it isn’t any more likely to cause severe disease.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved two full doses of AZD122, which has a top-line protective efficacy of 62%, as it decided there wasn’t enough data on a half dose/full dose combination that seemed to be more effective in trials with 90% protection rate.

The British Medical Association’s council chair Dr Chaand Nagpaul, welcomed the approval, but warned the rollout will require a massive step up in immunisation capacity.

“It is now crucial that supplies of this vaccine are given to as many GP practice sites and hospital hubs as possible and that this happens as quickly as possible so that we can begin vaccination en masse,” he said.

“We need to see a step change in distribution so that doctors can protect their patients and communities, beginning with those most at risk, and crucially this must include health and social care workers as they confront the virus on the front line.”

The BMA has previously said it is concerned about patchy access to the Pfizer/BioNTech vaccine by healthcare workers across the country.

EU orders another 100m doses of Comirnaty

The EMA is still reviewing the AZ vaccine, but yesterday exercised an option to acquire another 100 million doses of Comirnaty for distribution in the EU in 2021, taking the tally to 300 million doses.

Pfizer and BioNTech say they will be able to meet that order, agreed just two days after the first vaccinations against COVID-19 started in EU member states. The companies have previously said they will be able to supply up to 1.3 billion doses worldwide by the end of 2021.

The post AZ COVID-19 vaccine cleared in UK, dosing to start next week appeared first on .

‘I’ve never seen anything like it’: 2020 smashes records in global markets

From worst crash in a generation to record highs on news of a Covid vaccine, experts review the rollercoaster that was 2020

2020 has been the most remarkable year for the global financial markets. After the Covid-19 pandemic triggered the worst crash in a generation, unprecedented stimulus measures and vaccine breakthroughs have sent stocks roaring back to record highs.

In a year in which at least 1.7 million people died from coronavirus and unemployment soared in a global recession, world stock markets are ending 2020 up 13% – despite the latest surge in cases forcing further lockdowns this winter.

GUARDIAN: Stock markets in biggest fall since 2008 #TomorrowsPapersToday pic.twitter.com/1FX7ivVZZT

Related: As Airbnb’s shares go through the roof, we need to challenge the Big Tech monopoly | Will Hutton

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Amazon, AstraZeneca, Pfizer, Merck to Build $10M Digital Health Innovation Lab in Israel

Amazon, AstraZeneca, Pfizer, Merck to Build $10M Digital Health Innovation Lab in Israel
Rehovot Science Park

What You Should Know:

– Pfizer, AstraZeneca, Merck, and Teva, and Amazon Web Services (AWS) has been selected by the Israel Innovation Authority to establish an innovation lab in the fields of digital health and computational biology.

– The innovation lab located in the Rehovot Science Park will
receive a government budget of $10M over the next five years and is slated to
start operations in 2021.


Pfizer, AstraZeneca, Merck, and Teva, as well as the Israel Biotech Fund and tech giant
Amazon Web Services (AWS)— to establish an innovation lab in the fields of digital health
and computational biology. The companies were selected from a competitive bid process
conducted by the Israel Innovation
Authority
together with the National Digital Israel Initiative at the
National Digital Ministry.

The group will establish the Lab at the Rehovot Science Park
and invest in building a wet computational lab infrastructure in order to
assist early-stage entrepreneurs and startups to meet the challenges of the
healthcare industry, from the ideation stage to attaining proof of concept. The
Lab, scheduled to open in 2021, will be joining existing innovation labs as
part of the Israel Innovation Authority’s Innovation Lab Program.

$10M Operational Budget Over Next 5 Years

The innovation lab will operate on a government budget of
NIS 32 million ($10M USD), as well as additional funding from the partner companies.
The group will operate over the next five years, during which the Innovation
Authority, together with the National Digital Ministry, will finance 85% of a
total NIS 3 million budget for each startup that joins the lab, enabling them
to reach significant milestones in their technological development. The
Innovation Authority and National Digital Ministry will also participate in the
operating costs and in setting up the lab’s infrastructure.

Innovation Lab Focus Areas

The purpose of the Lab is to assist in the establishment and advancement of new startups developing innovative AI-based computational technologies aimed at discovering personalized solutions and treatments. The Lab will also help its startups — with the assistance of the lab partners and access they provide to their unique scientific know-how and leading experts — in developing groundbreaking medications and treatments. 

“This last year proved that the healthcare sector is rapidly transitioning to development and use of advanced technologies integrating engineering and biology, which has already led to more accurate results within a shorter time framework. This lab is part of the ‘Bio-convergence Strategy’ promoted by the Innovation Authority over the last year, aimed at establishing a successful, innovative ecosystem in the healthcare sector, which will serve as a proper basis for establishing innovative companies based on groundbreaking academic research performed in these areas in Israel. The expertise and vast experience of the lab partners will enable these companies to establish a significant, trailblazing industry in Israel,” said Aharon Aharon, CEO of the Innovation Authority.

Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

Shots:

  • The US FDA has accepted for Priority Review the sNDA is based on the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR)
  • CROWN is P-lll, parallel 2-arm trial in which 296 previously untreated advanced ALK-positive NSCLC were randomized in ratio 1:1 to receive LORBRENA monotherapy (n=149) or XALKORI monotherapy (n=147). Result: The 1EPs is (PFS) based on the blinded independent central review (BICR) and 2EPs involve PFS based on OS, ORR, intracranial objective response, and safety
  • Lorbrena is a tyrosine kinase inhibitor (TKI) especially developed to inhibit tumor mutations and to penetrate the blood-brain barrier

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: Michigan Health Lab

The post Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC) first appeared on PharmaShots.

Vulnerable should all get COVID-19 shot before summer, says NHS chief

NHS England’s chief executive Sir Simon Stevens has said that all vulnerable people over the age of 50 will be offered a COVID-19 vaccine by “late spring” in a message to healthcare workers.

The prediction comes after the NHS announced on Christmas Eve that more than half a million people had received the Pfizer/BioNTech shot approved in early December, but will depend on additional vaccine supplies coming “on stream”, according to Stevens.

There are around 25 million people classed as vulnerable due to their age or health conditions, and hitting that target will likely rely on the much-anticipated approval of the AstraZeneca/University of Oxford COVID-19 vaccine, said to be coming this week.

The UK has ordered 100 million doses of the AZ vaccine, which unlike the Pfizer/BioNTech shot can be stored and transported at normal temperatures, making it easier to distribute. Around 40 million doses are due to be delivered before the end of March. A third shot from Moderna isn’t expected to be available in the UK until well into next year.

The Pfizer/BioNTech vaccine – which was approved by the EU last week – is being delivered via a network of more than 80 hospital hubs and over 500 GP-led vaccination centres, as well as in care homes in the UK.

That will likely have to be expanded even further if the AZ vaccine is approved and as the immunisation programme gathers pace.

Stevens’ forecast – delivered to staff at a vacciination centre – came alongside a warning that NHS workers are “back in the eye of the storm”, with the number of coronavirus patients in hospitals higher than at the peak of the first wave.

There were around 20,500 hospitalised cases as of this morning, above a peak of just under 19,000 as the first wave hit in April. The UK also recorded a record number of lab-confirmed new cases yesterday at more than 41,000, although that figures reflects a higher level of testing nationally.

At the same time, the new, more transmissible variant of SARS-CoV-2 that was first identified in the UK has been detected in more than 20 other countries around the world, including several EU member states, India, Canada, Japan and Hong Kong.

The leading vaccine developers have said there is no reason their shots will not work against the new variant.

So far there is little evidence of “anti-vaxxer” resistance to the vaccine in the UK. However, in Spain – where more than a quarter of people said they would not take the vaccine in a recent survey – the health ministry has suggested it will set up a registry of people who refuse to be vaccinated and share it with other EU members.

The European Commission has said it expects to deliver 200 million doses of the Pfizer/BioNTech vaccine to EU countries by September 2021.

Novavax vaccine starts US phase 3

Meanwhile, another COVID-19 vaccine has entered the late-stage testing phase in North America. US biotech Novavax has started a phase 3 trial of its recombinant protein-based shot NVX-CoV2373 in the US and Mexico, adding to an ongoing phase 3 trial that started in the UK that is due to read out next year.

The UK government has already signed an agreement with the US biotech to buy 60 million doses of the vaccine in August if trials work out.

The post Vulnerable should all get COVID-19 shot before summer, says NHS chief appeared first on .

Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix in Oncology and Women’s Health

Shots:

  • Myovant & Pfizer will jointly develop & commercialize ORGOVYX (relugolix) in advanced prostate cancer & if approved, relugolix combination tablet in women’s health in the US & Canada. Myovant will receive ~$4.2B including $650M upfront, $200M in regulatory milestones for FDA approvals for relugolix combination tablet in women’s health, and tiered sales milestones upon reaching certain thresholds up to $2.5 billion in net sales for prostate cancer and women’s health indications
  • Additionally, Pfizer will receive an exclusive option to commercialize relugolix in oncology outside the US and Canada, excluding certain Asian countries and if Pfizer exercises the option to commercialize relugolix in oncology, Myovant will receive $50M and is eligible to receive double-digit royalties.
  • Relugolix is a GnRH receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol. Relugolix (120mg) is FDA approved as ORGOVYX for adult patients with advanced prostate cancer

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Myovant

The post Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix in Oncology and Women’s Health first appeared on PharmaShots.

A USD 4.2 Billion Myovant/ Pfizer Deal; Audentes Therapeutics’ ASPIRO Trial Free to Proceed; First Generic of Drug for Severe Hypoglycemia Gets Approval; Teleflex Acquires Z-Medica

A USD 4.2 Billion Myovant/ Pfizer Deal

Myovant Sciences have decided to put their forces and efforts together to advance the Prostate cancer market as they announced their partnership deal to develop and market relugolix for prostate cancer and women’s health. 

Relugolix is a once-daily, oral gonadotropin-release hormone (GnRH) receptor antagonist. If approved, it will be marketed under the brand name Orgovyx for prostate cancer as well as in women’s health in combination with estradiol 1.0 mg and norethindrone acetate (0.5 mg) in the US and Canada. However, for geographies other than the US and Canada, Pfizer has received an exclusive right to develop the drug in oncology except in certain Asian countries.

While Myovant is planning to handle regulatory interactions, drug supply, and advance the relugolix combination program, Pfizer is managing monetary needs by paying Myovant up to USD 4.2 billion – a deal that is split into upfront payments, and sales and regulatory milestone payments.

Audentes Therapeutics’ ASPIRO Trial Free to Proceed 

After almost a tough year of holds, the U.S. The Food and Drug Administration (FDA) decided to lift the clinical ban from  Audentes Therapeutics’ ASPIRO trial, which was aimed at investigating its AT132 for the treatment of X-linked myotubular myopathy (XLMTM), a rare neuromuscular disease. 

The ASPIRO trial is a two-part, open-label ascending dose study, and is examining the safety and preliminary efficacy of AT132 in children with XLMTM younger than five years old. X-linked myotubular myopathy (XLMTM) is a rare genetic neuromuscular disorder and leads to muscle weakness, respiratory failure, and early death. Approximately 1 in 40,000 to 50,000 newborn males are diagnosed with the disease.

The clinical hold was put after the death of three enrolled patients during the trial. However, as an early New year gift, the company can proceed with the trial keeping in mind a comprehensive view of past events. 

Welcome the First Generic of Drug for Severe Hypoglycemia

The U.S. Food and Drug Administration has given a green signal to the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia

Severe hypoglycemia is a condition associated with very low blood glucose and is referred to as a diabetic emergency. It is a complication associated with diabetic patients who take insulin and certain anti-diabetic tablets. To overcome this, Glucagon, a hormone in the body, helps the liver to quickly increase blood sugar levels. Thus, the same idea is behind the injection which is a synthetic version of human glucagon. The most common side effects associated with glucagon for injection are nausea and vomiting, a temporary increase in heart rate, as well as redness and swelling of the injection site.

The USFDA continually takes steps and initiatives to make high-quality generics available to people at affordable rates, and approval is another step in the direction. 

Teleflex Acquires Z-Medica

Teleflex Incorporated has finally completed the acquisition of Z-Medica, an industry-leading manufacturer of hemostatic products.

Teleflex is a global manufacturer of medical technologies and equipment aiming to add value to the healthcare and pharmaceutical industry. The company boasts of its wide spectrum of portfolio ranging from solutions in the fields of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology, and respiratory care. Acquisition of Z-Medica, is a Wallingford-based medical device company, will help bolster Teleflex’s overall armamentarium. 

Teleflex a few months back had announced a definitive agreement to acquire Z-Medica. As per the terms and conditions of the agreement, Teleflex will pay an upfront cash payment of USD 500 million at closing along with an additional sum of USD 25 million on achieving certain commercial milestones. Teleflex also took home certain tax attributes that might prove fruitful to the company.

The post A USD 4.2 Billion Myovant/ Pfizer Deal; Audentes Therapeutics’ ASPIRO Trial Free to Proceed; First Generic of Drug for Severe Hypoglycemia Gets Approval; Teleflex Acquires Z-Medica appeared first on DelveInsight Business Research.

NHS doctors ‘scrabbling’ to get vaccine amid alarm at Covid variant

Many medics ‘frustrated’ about low priority given to frontline staff at high risk of infection

Frontline NHS staff have been denied the Pfizer/BioNTech vaccine, leaving doctors alarmed and “scrabbling” to get immunised.

A new survey reveals that almost two-thirds of medics who responded to it have still not had the vaccine, half believe its delivery to the NHS frontline has been “ad hoc” and a third have no idea when they will be offered it. They fear the government’s decision to prioritise over-80s and care home staff above health workers has left them at risk of catching the disease, especially given the emergence of the coronavirus variant, which is 70% more transmissable.

Continue reading…

PharmaShots Weekly Snapshots (Dec 21-23, 2020)

Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer

Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s Approval, HER2-positive Breast Cancer, Phesgo, receives, Roche, Treatment

AMO Pharma Initiates P-II REACH-CDM study of AMO-02 (tideglusib) to treat Congenital Myotonic Dystrophy

Published: Dec 22, 2020 | Tags: AMO Pharma, AMO-02, Initiation, REACH-CDM, Treatment of Congenital Myotonic Dystrophy

Ocular Therapeutix Reports sNDA Submission of Dextenza (dexamethasone ophthalmic insert) to the US FDA for Ocular Itching

Published: Dec 22, 2020 | Tags: (dexamethasone ophthalmic insert), Dextenza, Ocular Itching, Ocular Therapeutix, reports, sNDA Submission, Us FDA

Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma

Published: Dec 21, 2020 | Tags: Autoleucel (cilta-cel), BLA, Initiates, Janssen, Multiple Myeloma, Rolling, Submission, Us FDA

Voyager Therapeutics Provides Update on NBIB-1817(VY-AADC) Program to Treat Parkinson Disease

Published: Dec 22, 2020 | Tags: (VY-AADC), NBIB-1817, Parkinson Disease, Provides, Update, Voyager Therapeutics

Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of Multiple Myeloma

Published: Dec 22, 2020 | Tags: (daratumumab), DARZALEX, Health Canada Approval, Janssen, Multiple Myeloma, receives, Treatment

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma

Published: Dec 22, 2020 | Tags: Asthma, AstraZeneca, Corticosteroid, Dependent, Oral, P-III, patients, reports, results, Severe, SOURCE, Tezepelumab, Trial

Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19

Published: Dec 21, 2020 | Tags: (BNT162b2), BioNTech, Comirnaty, Conditional Marketing Authorization, COVID-19, EC, Pfizer, receives

Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS

Published: Dec 21, 2020 | Tags: (peginterferon beta-1a), Biogen, European Commission, Marketing Authorization, Plegridy, receives, Relapsing-Remitting MS

Servier to Acquire Agios’ Oncology Business for ~$2B

Published: Dec 21, 2020 | Tags: $2B, Agios, Agreement, business, Its, Oncology, Royalties, Sell, Servier, Signs

Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema

Published: Dec 21, 2020 | Tags: Diabetic, Edema, Faricimab, Global, Macular, P-III, reports, results, Roche, Studies, Two

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Published: Dec 21, 2020 | Tags: (osimertinib), approval, AstraZeneca, Early-Stage, EGFR-mutated Lung Cancer, receives, Tagrisso, US FDA’s

Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19

Published: Dec 18, 2020 | Tags: Against, COVID-19, EUA, Moderna, mRNA-1273, receives, US, Us FDA

Ultragenyx Signs a License Agreement with Mereo for Setrusumab in Osteogenesis Imperfecta

Published: Dec 17, 2020 | Tags: Agreement, Imperfecta, Mereo BioPharma, Osteogenesis, Setrusumab, Signs, Ultragenyx

ViiV Healthcare’s First Long-Acting Injectable Receive EC’s Approval for the Treatment of HIV

Published: Dec 21, 2020 | Tags: EC Marketing Authorization, Edurant Receives, HIV-1 Infection, Rekambys, ViiV Healthcare, Vocabria (cabotegravir)

Philips to Acquire BioTelemetry for ~$2.8B

Published: Dec 18, 2020 | Tags: Acquires, BioTelemetry, Philips

Merck Signs a ~$1B Pact with Janux to Develop Cancer Therapies Using T Cell Engager Technology

Published: Dec 18, 2020 | Tags: Agreement, Candidates, Develop, Drug, Engager, Immuno, Janux Therapeutics, Merck, Novel, Oncology, Signs, T Cell, technology, Using

GSK Signs a License Agreement with Sosei Heptares Targeting Immune Disorders of the Digestive System

Published: Dec 21, 2020 | Tags: Digestive System, Global License Agreement, GPR35, GSK, Immune Disorders, Signs, Sosei Heptares

Related News: PharmaShots Weekly Snapshots (Dec 14-18, 2020)

The post PharmaShots Weekly Snapshots (Dec 21-23, 2020) first appeared on PharmaShots.

AMA Adds 3 Additional CPT Codes for AstraZeneca’s COVID-19 Vaccine

AMA Adds 3 Additional CPT Codes for AstraZeneca's COVID-19 Vaccine

What You Should Know:

– The American Medical Association (AMA) announced the addition of three Current Procedural Terminology (CPT) codes for AstraZeneca’s COVID-19 vaccine.


The American Medical Association (AMA) today announced that
the Current Procedural Terminology (CPT®) code set is
being updated by the CPT Editorial Panel to include immunization and
administration codes that are unique to the COVID-19 vaccine under development
by AstraZeneca and University of Oxford.

The new CPT codes will be effective for use on the condition
that the AstraZeneca vaccine receives approval or emergency use authorizations
from the Food and Drug Administration (FDA). The AMA is publishing the new CPT
codes now to ensure electronic systems across the U.S. health care
system are updated and prepared for the prospect of FDA approval or
authorization for the AstraZeneca vaccine.

Growing List
of CPT Codes to Support COVID-19 Vaccines

The AstraZeneca vaccine joins two other COVID-19 vaccines that were previously issued unique CPT codes to report vaccine-specific immunizations once FDA approval or authorization has been granted. On Nov. 10, the AMA announced that COVID-19 vaccines developed by Pfizer and Moderna had been issued unique CPT codes to clinically distinguish each vaccine for better tracking, reporting, and analysis that supports data-driven planning and allocation

AstraZeneca COVID-19 Vaccine CPT Codes Overview

The new
Category I CPT code and long descriptor for the AstraZeneca vaccine are:

91302: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative-free, 5×1010 viral particles/0.5mL dosage, for intramuscular use

In addition to the new vaccine-specific product CPT code, the AstraZeneca vaccine has been issued vaccine administration CPT codes that are distinct to its two-dose immunization schedule. These CPT codes report the actual work of administering the vaccine, in addition to all necessary counseling provided to patients or caregivers and updating the electronic record.

For quick reference, the new vaccine administration CPT codes and long descriptors for the AstraZeneca vaccine are:

0021A: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative-free, 5×1010 viral particles/0.5mL dosage; first dose 

0022A: second dose

In addition to the long descriptors, short and medium descriptors for all the new vaccine-specific CPT codes can be accessed on the AMA website, along with several other recent modifications to the CPT code set that have helped streamline the public health response to the SAR-CoV-2 virus and the COVID-19 disease.

“A mass vaccination effort with the first available COVID-19 vaccines presents enormous logistical challenges,” said AMA President Susan R. Bailey, M.D. “The ability to correlate each COVID-19 vaccine with its own unique CPT code provides analytical and tracking advantages that ensures optimal vaccine distribution and administration, especially for patients who will need to complete the two-dose immunization schedule.”


INVEST Precision Medicine Pitch Perfect winner spotlight: TrialSpark

Judges picked TrialSpark as the winner on the life sciences track of the pitch competition at MedCity’s virtual precision medicine conference. While the company is focused on improving clinical trials for others, it hopes eventually to bring drugs of its own to market.

Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19

Shots:

  • The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio of (1:1) for COVID-19. The approval follows CHMP’s positive opinion to authorize the vaccine
  • The P-III demonstrated 95% ER in participants without prior SARS-CoV-2 infection (first primary objective) and in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose
  • The CMA is valid in all 27 member states of the EU while the companies are ready to immediately ship initial doses to all the member state

Click here ­to­ read full press release/ article | Ref: BusinessWire  | Image: Market Place

The post Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19 first appeared on PharmaShots.

‘Highly likely’ BioNTech vaccine will work against new strain, says CEO

BioNTech CEO Ugur Sahin has said that it is “highly likely” the company’s COVID-19 vaccine will work against the more infectious strain circulating in the south east of England, although further studies will be needed.

Sahin was addressing a news conference after the vaccine was approved by the European Union, three weeks after the shot was independently backed by the UK’s regulator.

The variant has caused concern globally, prompting dozens of countries to close travel borders with the UK to prevent it from spreading.

There is no evidence to suggest the new strain causes more serious illness, but it does show variations in the “spike” protein that the virus uses to infect cells – the same protein that the Pfizer/BioNTech shot uses to confer immunity.

Sahin said: “We don’t know at the moment if our vaccine is also able to provide protection against this new variant.

“But scientifically, it is highly likely that the immune response by this vaccine also can deal with the new virus variants.”

Proteins on the UK variant are 99% the same as on the prevailing strains and BioNTech has “scientific confidence” that the vaccine will be effective.

“But we will know it only if the experiment is done and we will need about two weeks from now to get the data,” Sahin said. “The likelihood that our vaccine works … is relatively high.”

It would take around six weeks to adjust the vaccine for the new variant in a worst-case scenario, although regulators would likely have to approve the changes before the vaccines could be used.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is reportedly close to a decision on a rival vaccine from Oxford University and AstraZeneca and may make a ruling in the coming days.

The MHRA begun a rolling review of the vaccine early in November, around the same time as it began to review Pfizer’s shot.

It is thought the review has been delayed by the range of results produced by the vaccine, after a manufacturing error led to the accidental discovery that an initial half dose of the two-shot vaccine seemed to produce stronger protection.

Feature image copyright BioNTech SE 2020, all rights reserved

The post ‘Highly likely’ BioNTech vaccine will work against new strain, says CEO appeared first on .

FDA gives nod to Moderna vaccine for Covid-19

The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.

Belgian minister tweets EU’s Covid vaccine price list to anger of manufacturers

Pharmaceutical companies complain of breach of confidentiality after amount EU has agreed to pay for leading vaccines goes public

A Belgian minister has inadvertently blown the lid off a sensitive and commercial secret – the price that the EU has agreed to pay for the leading Covid vaccines.

Belgium’s budget state ecretary, Eva De Bleeker, posted the price list on Twitter, with the amounts of each vaccine that her country intends to buy from the EU. The tweet was quickly deleted, but not soon enough to prevent interested parties taking screenshots, which have now made it public knowledge.

Oxford/AstraZeneca: €1.78

Johnson & Johnson: $8.50

Sanofi/GSK: €7.56

Pfizer/BioNTech: €12

CureVac: €10

Moderna: $18

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FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote

The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts.

Yesterday’s advisory panel meeting voted 20-0 in favour of approving Moderna’s vaccine and although the vote is non-binding, you could probably bet your house on the FDA backing the shot as it rarely goes against the advice of its experts after such strong backing.

The vaccine was also given a glowing review by FDA staffers in a briefing document posted ahead of the meeting and looks set to become the second COVID-19 vaccine to hit the US market after Pfizer/BioNTech’s rival was approved last week.

Pfizer’s vaccine was approved within a day of a positive vote from the Vaccines and Related Biological Products Advisory Committee.

Roll-out of the Pfizer vaccine has already begun and FDA commissioner Stephen Hahn said the agency will work “rapidly” towards issuing an Emergency Use Authorization for Moderna’s shot.

The US has agreed to buy 200 million doses and there are six million doses ready move to ship as soon as the vaccine is officially approved.

Yesterday’s panel vote heard that the vaccine worked in 94% of cases, based on clinical data gathered so far, and is safe.

It is also slightly easier to move around – although it is an mRNA-based shot like Pfizer the storage temperature is around -20C, considerably less demanding than temperatures of around -75C required to maintain the integrity of its already-approved rival.

Moderna’s vaccine is also given in two shots, with the injections four weeks apart compared with the three-week interval required for Pfizer’s.

The UK has also pre-ordered seven million doses of the Moderna vaccine, which is also being reviewed by the country’s regulator the Medicines and Healthcare products Regulatory Agency (MHRA).

Canada also plans to get two million doses by March, part of a total 56 million doses ordered from Moderna.

The European Union has also announced a contract to buy 80 million doses and an option to buy 80 million more once the vaccine is formally approved.

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Precision measurement in 2021: Why accuracy is key to the vaccine ‘cold chain’ and disrupting the spread of Covid-19

By creating new networks for 24/7 temperature monitoring, alerts and reporting, the challenges of deploying transportation at ultra-low temperatures can be overcome. This also illustrates the crucial role that precision measurement will have to play.

Trials of Valneva COVID-19 vaccine begin in UK

Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech.

France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR).

It is the first publicly announced inactivated COVID-19 vaccine candidate to begin clinical development in Europe.

The vaccine is based of inactivated viruses grown in culture and includes an adjuvant used to boost the immune response.

Primary endpoint read-out will be two weeks of completion of the immunisation given in two doses, 21 days apart.

Valneva plans to include more than 4,000 participants in additional trials, which it believes could support an initial regulatory approval in the fourth quarter of 2021.

But the two-dose schedule being used by many of the vaccines is proving to be a stumbling block as the shot is rolled out across the UK.

It’s vital to track who received the vaccine and when, so they can be called in for the second booster shot at the right time.

But according to Sky News GP practices have been forced to collect data on the rollout of the vaccine shot by hand.

This follows problems with the software being used to keep track of who has been given the jab.

Citing a senior health official, Sky said that the IT system used was “failing constantly” and that GPs were “having to record on paper and then transfer”.

Vaccine minister Nadhim Zahawi tweeted what the Department for Health Social Care described as “provisional figures” on how many people had received the vaccine on Wednesday morning.

The official said GPs were not able to find out who had already been vaccinated by a hospital, causing delays as checks were made and raising the risk people might get missed, or even vaccinated twice.

In the US, advisers to the FDA are to meet later today in a vote that will inform whether Moderna’s rival vaccine should get an Emergency Use Authorization.

The vote from the Vaccines ands Related Biological Products Advisory Committee is non-binding but the FDA usually follows the advice of its experts.

FDA staffers have already given the vaccine a glowing review ahead of the meeting.

According to the World Health Organization, there are 52 candidate vaccines in clinical development, and 13 have made it through to phase 3 trials.

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Tensions mount over handling of UK Covid vaccine rollout

With overall costs for vaccinating the UK population at £12bn, the public accounts committee flags ‘highly unusual’ arrangements

Vaccinating the population against Covid-19 will cost up to £12bn, Whitehall’s spending watchdog has disclosed, amid details of tensions between health bodies over the rollout.

The National Audit Office said the government would spend up to £11.7bn on purchasing and manufacturing Covid-19 jabs for the UK before deploying them in England.

Related: Can the UK deliver on the Covid vaccine rollout? | Stephen Buranyi

Related: Kate Bingham: well-connected but under-fire UK vaccines chief

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Pfizer/BioNTech COVID-19 vaccinations start across the US

Hospitals in the US have started vaccinating their front-line staff against COVID-19, as deaths in the country crossed the 300,000 threshold with more than 200,000 new cases reported yesterday.

Shipments of Pfizer/BioNTech’s mRNA vaccine BNT-162b are being shipped to hundreds of hospitals and other distribution facilities across the US, with the first three million doses earmarked for  healthcare workers and elderly.

Just three days after the FDA granted Emergency Use Authorisation for the shot, the first dose administered outside a clinical trial was given yesterday to intensive care nurse Sandra Lindsay at the Long Island Jewish Medical Center in Queens, New York.

It’s likely to be months before all eligible healthcare workers for the first wave receive vaccinations. Hopeful eyes are already turning to the Moderna’s mRNA-1273 vaccine, which is scheduled to be reviewed by FDA advisors on Thursday, to help boost available supplies.

The first nursing home residents aren’t expected to start receiving their doses until next week, according to Army General Gustave Perna, chief operating officer for Operation Warp Speed, the US vaccination task force.

The immunisation programme comes as hospitals around the country say they are already struggling to cope with the influx of COVID-19. The US has the highest death toll from the disease worldwide, ahead of Brazil, India and Mexico, and there are fears of a further spike as the holiday season gathers pace.

The US government is predicting that 20 million Americans will have received at least one of the two doses of the vaccines by the end of the year, with another 30 million set to be immunised during January and another 50 million by the end of March.

President Trump took a break from his relentless tweeting about alleged election fraud to briefly acknowledge the milestone on the path to recovery from the pandemic.

Canada also gave the first doses of BNT-162b to healthcare workers yesterday, a week after the UK started the ball rolling on its own vaccination programme – the first to get started in the world.

Because BNT-162b is made from RNA, it has strict temperature requirements and has to be stored at -70 C in dry ice to prevent it from breaking down, although it can be kept at regular refrigeration temperatures temporarily – around three days – after being defrosted for administration.

That will pose a logistical challenge for all countries, requiring a massive and carefully controlled shipping operation as doses come off the production line at Pfizer’s facility in Michigan.

Around 5 million doses of Moderna’s vaccine could be ready to ship straightaway if the FDA gives a green light, possibly as soon as Friday, with distributor McKesson handling that roll-out. Moderna’s shot is a little easier to handle as it only needs to be kept at -20 C.

Meanwhile, Operation Warp Speed’s chief executive Dr Moncef Slauoi also suggested yesterday that Johnson & Johnson could get approval for its shot in late January or early in February, while AstraZeneca may be in a position to seek FDA approval as early as February.

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FTA for Gannex’s ASC4; Disappointment for Incyte’s Ruxolitinib; Historic win for Pfizer, BioNTech’s COVID Vaccine; Alexion buyout; the debut of InnoSkel

Gannex received US FDA fast track designation for its NASH drug, ASC42 an FXR Agonist

Gannex Pharma has received Fast Track designation approval from FDA for its drug candidate ASC42 for non-alcoholic steatohepatitis (NASH). The FTA designation will help the pharma company to advance its research and development in the NASH landscape and help its commercialization in the market.

At present, there are no approved therapies for NASH. The present NASH treatment market is dominated and supported by off-label therapies. DelveInsight estimated that the coming future for NASH market is expected to experience entry of more such off-label therapies unless an approved cure arrives.

The US FDA decision to grant FTA to ASC42 depicts the potential of the therapy in addressing the unmet medical needs for NASH patients. ASC42 is an oral fatty acid synthase (FASN) inhibitor that has managed to significantly reduce the liver fat in Phase II clinical trial (FASCINATE-1).

Gannex has two additional drug candidates as well that are at the clinical stage in its NASH pipeline, ASC40 and ASC41.

Incyte’s Ruxolitinib failed to meet Primary Endpoint in the Phase 3 RUXCOVID Study for COVID-19 Associated Cytokine Storm

Incyte announced the results from the Phase III RUXCOVID study investigating the safety and efficacy of ruxolitinib (Jakafi®) for patients 12 years and older with COVID-19 associated cytokine storms.

Ruxolitinib is an orally administered inhibitor of the JAK 1 and JAK 2 tyrosine kinases. The Phase III RUXCOVID study tested ruxolitinib on top of standard of care or SoC therapy compared to SoC treatment alone in patients with COVID-19.

The initial data from the trial demonstrated no statistically significant reduction in the number of hospitalized COVID-19 patients receiving ruxolitinib plus SoC therapy who experienced severe complications including death, mechanical ventilation or ICU care by Day 29, compared to SoC treatment alone.

The drug, Ruxolitinib, is commercialized by Incyte in the US; and is licensed to Novartis outside the U.S. Sold under the name Jakafi, it is FDA-approved for the treatment of polycythemia vera (PV) in adults.

Pfizer, BioNTech COVID-19 Vaccine rolls out in a watershed moment

In a historic first, the US FDA issued an Emergency Use Authorization (EUA) to the COVID-19 mRNA, BNT162b2, vaccine candidate for COVID-19 of Pfizer-BioNTech. The duo plans to accumulate additional data and file for Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.

COVID-19 still continues to ravage human society turning the economy upside down. And, the EUA is a pivotal move in the quest to turn back things to normal. The vaccine is the first-ever mRNA vaccine to get to the EUA and is developed in record-time low.

The decision of the regulatory agency was based on the results from a pivotal Phase 3 clinical study announced last month and published this week in The New England Journal of Medicine. The data depicted the efficacy rate of the vaccine of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective).

The U.K. was the first to give its nod to the vaccine followed by Bahrain, Canada, Saudi Arabia and now, the U.S.

In a rare move for rare portfolio, AstraZeneca buys Alexion for USD 39B cash/stock deal

AstraZeneca is ready to dish-out USD 39 Billion to acquire rare disease stalwart Alexion. It seems a global oncology performer, AZ is now taking interest in the rare disease landscape.

Not long ago, another pharma titan, Gilead acquired Immunomedics by shelling-out USD 21 Billion in one of the most expensive and bold moves. However, AstraZeneca has outwon Gilead with even a large one with a prime focus on rare disease portfolio.

After the acquisition, the companies plan to strengthen a spectrum of domains, technologies, and therapeutic areas to bring innovative therapies to people. The duo will also have an expanded coverage across primary, speciality and highly specialised care and increased geographical reach.

The combined entity will put forward two rapidly converging, patient-centric models of care delivery with combined strengths in immunology, biologics, genomics and oligonucleotides to drive future medicine innovation

Welcome the new entrant in Gene therapy market: InnoSkel

Elvire Gouze, a scientist, entrepreneur, and an expert in skeletal disorders, has come up with another startup company, InnoSkel, with an aim to move forward in developing innovative gene therapy platform for a wide variety of life-threatening skeletal diseases.

The company is officially launched with €20 million ($24 million) in first-round financing led by Jeito Capital alongside Vida Ventures and the Turenne Group to advance the platform. InnoSkel is Jeito’s third investment in the past four months, after SparingVision and Neogene.

Earlier the scientist has sold her first biotech, Therachon, to Pfizer for a hefty USD 810 million. In similar lines with Therachon, InnoSkel is also committed to focusing on diseases that cause dwarfism, however, this time the approach towards treatment is different.

The proceeds from the financing are expected to be consumed in advancing InnoSkel’s asset pipeline from its dedicated gene therapy platform, including a group of rare and life-threatening skeletal disorders collectively known as type 2 collagenopathies, the most severe being, a neonatal presenting skeletal disorder called Spondyloepiphyseal Dysplasia congenita (SEDc).

The post FTA for Gannex’s ASC4; Disappointment for Incyte’s Ruxolitinib; Historic win for Pfizer, BioNTech’s COVID Vaccine; Alexion buyout; the debut of InnoSkel appeared first on DelveInsight Business Research.

Family doctors begin COVID-19 immunisation drive in UK

The roll-out of the biggest vaccination programme in the history of the UK’s NHS is gathering pace, as family doctors and their teams begin taking delivery of Pfizer/BioNTech’s COVID-19 shot.

In a statement the NHS said that GP practices in more than 100 parts of the country are taking delivery of the vaccine today.

Some clinics will begin immunisations this afternoon and the majority will start tomorrow (Tuesday), the NHS said.

The vaccine, which was approved in the UK earlier this month, will be administered by teams of nurses, paramedics and pharmacists.

Those aged over 80, as well as care home workers and residents, will get the vaccine first as they are considered to be in the group at highest risk of getting the disease.

Care home residents will start to receive the vaccine later this week as distributors finalise the processes to deliver the Pfizer/BioNTech vaccine, which must be stored at around -70c to maintain its integrity.

Practice teams are redesigning sites to put in processes to meet these logistical challenges and the NHS will contact people in the priority groups when it is their turn to receive the vaccine.

Dr Simon Hodes, a GP from Watford told the BBC that his surgery is due to begin vaccinations on Monday, adding that very few of his patients had worries about the shot.

Hodes said his surgery had introduced a “military-style operation” to ensure vaccine doses are not wasted.

Dr Nikki Kanani, a practising GP and NHS director of primary care, said: “GPs, nurses, pharmacists and other primary care staff are eager to play their part in protecting people against coronavirus.

“This is the greatest vaccination programme ever undertaken by the NHS and, to help vaccinate people safely we will be working with local communities to deliver it in convenient and familiar settings.

“As a GP I am proud to be part of this huge national effort to protect our patients against the virus and I would urge the public to come forward when they are called up for the vaccine.”

Feature image copyright BioNTech SE 2020, all rights reserved

 

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Pfizer and BioNTech’s BNT162b2 Receives the US FDA’s EUA to Prevent COVID-19

Shots:

  • Pfizer & BioNTech received the US FDA’s EUA for BNT162b2 for patients aged ≥16yrs with COVID-19. The companies are gathering additional data & prepared to file a planned BLA with the US FDA anticipating full approval in 2021
  • The EUA is based on P-III pivotal study demonstrating 95% efficacy in participants without prior SARS-CoV-2 infection & also in participants with/ out prior infection
  • In Jul 2020, the companies collaborated with the HHS & DoD to meet the Operation Warp Speed program goal to deliver doses of a vaccine for COVID-19

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Financial Times

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PharmaShots Weekly Snapshots (Dec 7-11, 2020)

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, Sign

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

Published: Dec 10, 2020 | Tags: (atezolizumab), ESMO Virtual Congress 2020, IMvigor010 Study, Muscle-Invasive Urothelial Cancer (MIUC), P-III, reports, results, Roche, Tecentriq

Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

Published: Dec 9, 2020 | Tags: (BIIB037) US FDA, aducanumab, Alzheimer Disease, Biogen, J-NDA Submission, reports

Gilead to Acquire MYR for ~$1.4B

Published: Dec 10, 2020 | Tags: ~$1.4B, Acquire, Gilead Sciences, MYR GmbH

Boehringer Ingelheim to Acquires NBE-Therapeutics ~ $1.5B

Published: Dec 10, 2020 | Tags: Acquires, Boehringer Ingelheim, NBE-Therapeutics

Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Published: Dec 9, 2020 | Tags: (BNT162b2), BioNTech, COVID-19, Health Canada Authorization, Interim Order, patients, Pfizer, receives

Google Launches Health Research App Focusing on Respiratory Illnesses

Published: Dec 9, 2020 | Tags: App, COVID-19, Flu, Google, Launches, Virtual Medical Research

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

Published: Dec 9, 2020 | Tags: HR+/HER2- Metastatic Breast Cancer, Kisqali, MONALEESA-7 Trial, Novartis, P-III, reports, results

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Published: Dec 9, 2020 | Tags: Collaborates, COVID-19, Moderna, Roche, SARS-CoV-2 Ab Test, Vaccine Trials

Lilly Reports Results of Tirzepatide in P-lll SURPASS-1 Monotherapy Trial for Type-2 Diabetes

Published: Dec 9, 2020 | Tags: Lilly, Monotherapy Trial, P-lll, reports, results, SURPASS-1, Tirzepatide, Type-2 diabetes

Boehringer Ingelheim to Acquires Labor Dr. Merk & Kollegen for Boosting its Next Generation Cancer Immunology Program

Published: Dec 9, 2020 | Tags: Acquires, Boehringer, Cancer Immunology Program, Kollegen, Labor Dr. Merk, Next Generation, Strength

Elsevier Acquires Shadow Health

Published: Dec 9, 2020 | Tags: Acquires, Elsevier, Extensive Portfolio, Shadow Health

Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

Published: Dec 8, 2020 | Tags: 62, Across, ALL, Annual, antibody, ASH, Bispecific, Blood, cancers, Data, From, Meeting, Portfolio, Presents, Range, Roche, Virtual

Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

Published: Dec 8, 2020 | Tags: Advanced or Metastatic Non-Small Cell Lung Cancer, Amgen, Breakthrough Therapy Designation, KRAS G12C, Mutation, receives, Sotorasib, US FDA’s

Medtronic Launches Carpediem as the First Pediatric and Neonatal Acute Dialysis Machine in the US

Published: Dec 8, 2020 | Tags: Acute, Carpediem, Dialysis, First, Launch, Machine, Medtronic, neonatal, Only, Pediatric, System, US

AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19

Published: Dec 8, 2020 | Tags: AstraZenca, AZD1222, Clinical Trials, COVID-19, Four, Interim Analysis, P-lll, reports, results

Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

Published: Dec 8, 2020 | Tags: (ABL001), ASCEMBL Study, Asciminib, Chronic, Chronic Myeloid Leukemia, Novartis, P-lll, Philadelphia Chromosome, reports, results

RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

Published: Dec 8, 2020 | Tags: Artificial Intelligence, Multi-Year Collaboration, Novartis, Ophthalmology, Provide, RetinAI, Signs, Solutions

Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2

Published: Dec 7, 2020 | Tags: Agreement, Astellas, Commercialization, Development, KaliVir Immunotherapeutics, Novel, Oncolytic, Signs, VET2-L2, Virus

Qiagen Launches QuantiFERON SARS-CoV-2 RUO Solution for COVID-19

Published: Dec 7, 2020 | Tags: COVID-19, Launches, Qiagen, QuantiFERON, SARS-CoV-2 RUO, Solution

Bayer Signs an Exclusive Worldwide License Agreement with Atara for Mesothelin-Targeted CAR T-cell Therapies to Treat Solid Tumors

Published: Dec 6, 2020 | Tags: Agreement, Atara, Bayer, Exclusive, License, Mesothelin-Targeted CAR T-cell Therapies, Signs, Solid Tumors, Worldwide

Nektar Therapeutics Presents Preclinical Data of NKTR-255 in P-Ib/II Study at ASH 2020

Published: Dec 7, 2020 | Tags: 2020, 62nd, Annual, ASH, Meeting, Nektar Therapeutics, NKTR-255, P-Ib/II, preclinical, Presents, results, study

AbbVie Reports Results of Imbruvica (ibrutinib) in Two P-III Studies as 1L Treatment for Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, AbbVie, CLL, ILLUMINATE Study, Imbruvica, Integrated Analysis, Long-Term, P-lll, reports, RESONATE-2

Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma

Published: Dec 7, 2020 | Tags: (polatuzumab vedotin), (R/R) Diffuse Large B-Cell Lymphoma, Bendamustine, GO29365 Study, MabThera / Rituxan (rituximab), P-lb/ll, Polivy, reports, Result, Roche

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Published: Dec 7, 2020 | Tags: 62nd, Annual, ASH, Haemophilia A, HAVEN, Hemlibra, I-IV, Meeting, P-III, People, Presents, results, Roche, Studies, Virtual

AstraZeneca Reports Long-Term Efficacy and Tolerability of Calquence (acalabrutinib) in P-ll ACE-LY-004 Study for MCL

Published: Dec 7, 2020 | Tags: (acalabrutinib) in P-ll ACE-LY-004 Study for Relapsed or Refractory Mantle Cell Lymphoma, AstraZenca, Calquence, Long-Term Efficacy, reports, Tolerability

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

Published: Dec 5, 2020 | Tags: Based, CLL14, combination, MURANO, P-III, People, R/R CLL, reports, results, Roche, Studies, Venclexta, Venclyxto

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin Lymphoma

Published: Dec 5, 2020 | Tags: Adult, iNHL, Kite, P-II, patients, Refractory, Relapsed, reports, results, study, Yescarta, ZUMA-5

Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, High-Risk Chronic Lymphocytic Leukaemia, ILLUMINATE Study, Imbruvica, Janssen, P-lll, reports, RESONATE-2, results

Related Post: PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

The post PharmaShots Weekly Snapshots (Dec 7-11, 2020) first appeared on PharmaShots.

FDA advisers vote in favour of Pfizer/BioNTech COVID-19 shot

Advisers to the FDA have voted in favour of approving Pfizer and BioNTech’s COVID-19 vaccine, with a near-unanimous backing from an expert committee.

While the decision of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is non-binding, the FDA seldom goes against the ruling of its advisers when making regulatory decisions.

However has were some concerns raised, reflected in the 17 to 4 vote in favour of approval.

Some experts in the public meeting were concerned about the short length of the human trial so far as well as the potential side-effects for people with allergies or pregnant women.

Already approved in the UK, this is the first time that mRNA technology has been used to create a vaccine.

There were also concerns about whether the vaccine should be used in 16-17 year-olds because of a lack of safety data in this group, balanced against the fact people from this age group are unlikely to fall seriously ill.

The committee also considered two cases of allergic reactions seen in the UK this week and has asked Pfizer to monitor for severe allergic reactions.

This may lead to further advice on the label of the vaccine if the FDA decides to go ahead with the Emergency Use Authorization that Pfizer is asking for.

The phase 3 data demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose.

Pfizer pointed out that the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine.

Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored for an additional two years after their second dose to assess long-term protection and safety.

 

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Can the UK deliver on the Covid vaccine rollout? | Stephen Buranyi

The challenge of delivering vaccines on this scale are hard, but are firmly within the world of logistics, engineering, and politics

The UK has become the first country to approve one of the coronavirus vaccines that the entire world has been desperately waiting for. And on Tuesday it delivered the first dose, to 90-year-old Margaret Keenan in Coventry. We should be very pleased about this. But, as with every other stage of the pandemic, the final stretch brings a new set of unprecedented challenges. The world is watching as the UK becomes the first test case of our collective ability to manufacture, ship, and deliver an entirely new class of vaccines, on a scale and speed that no previous vaccination drive in history has ever approached.

The thing everyone knows about the Pfizer-BioNTech vaccine is that it needs to be extremely cold. The mRNA that makes up the vaccine payload is the same stuff your cells use to send short-lived genetic instructions. It’s a messenger that isn’t supposed to stick around, as temporally fragile as a Snap on Snapchat. The vaccine is happiest at -70C, and after thawing can be kept at between 4C and -8C – the temperature of a regular fridge – for just five days before it degrades. Most logistics providers aren’t set up to ship at -70C, and while university labs and large hospitals generally have some -70C freezers, GP surgeries and smaller centres do not. The temperature for shipping and storage has been identified as one of the biggest challenges in getting this vaccine out.

The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.

Stephen Buranyi is a writer specialising in science and the environment

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Cyberattack targets EMA, hacks COVID-19 vaccine data

The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed.

In a terse statement, the EU regulator confirmed its security had been breached and said it had launched an investigation with law enforcement, but would not be providing any additional information while that probe was underway.

Shortly after however BioNTech confirmed that documents submitted as part of its marketing application for coronavirus vaccine BNT-162b had been accessed by the hackers.

Responding to fears that the review could be delayed, the company said it had been assured by the EMA that the timeline should not be affected. The agency has indicated it should complete its review by 29 December.

BNT-162b is already approved in the UK and Canada, and the first UK patients started to receive the shot on Tuesday this week. The EMA is also reviewing another vaccine from Moderna, but at the moment it’s not clear if data from that programme has also been compromised.

“It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed,” said BioNTech in a statement on its website.

It added that it had publicised the breach “given the critical public health considerations and the importance of transparency”.

The cyberattack came just days after international enforcement agency Interpol warned that organised criminals may try to target COVID-19 vaccine supply chains, for example by falsification, theft and illegal advertising of unlicensed shots.

Europol meanwhile warned earlier this year that criminal networks are exploiting the COVID-19 pandemic with a surge in cybercrime, targeted thefts and counterfeiting, including attempts to target organisations through business email compromise (BEC), which can be used to harvest sensitive data, siphon off funds or damage its reputation.

There’s no indication yet who was behind the EMA hack, but a volunteer group set up to tackle cybercrime related to COVID-19 – CTI League – has suggested that one motivation could be to uncover details about the supply and distribution of vaccines.

The group’s found Marc Rogers told Reuters that information “potentially significantly increases the attack surface for the vaccine”.

IBM recently said an email phishing campaign had targeted organisations linked to the Cold Chain Equipment Optimisation Platform (CCEOP) of Gavi, the international vaccine alliance, suggesting that the sophistication of the assault pointed to a nation state being the culprit.

“Without a clear path to a cash-out, cyber-criminals are unlikely to devote the time and resources required to execute such a calculated operation,” according to the tech giant’s Security X-Force.

There has also been reports that hackers linked to North Korea, South Korea, Iran, Vietnam, China and Russia have tried to steal information about vaccines, targeting pharma companies and other organisations involved in COVID-19 medicine R&D, according to the news agency.

In October, Indian pharma company Dr Reddy’s Laboratories, which is helping to conduct late-stage testing of Russia’s Sputnik V COVID-19 vaccine, said it had been hit by a cyberattack that disrupted its production facilities.

Sam Curry, chief security officer at Cybereason, is convinced that a nation state is behind the EMA attack, saying: “Cyberattacks on the global COVID-19 vaccine distribution network from nation-states China, Russia and North Korea are diabolical in nature and acts of war.”

While acknowledging the average person “might be asking themselves why nation-state actors…are deliberately sowing doubt and confusion around the world at the worst possible time,” Curry says there is tremendous value in interfering with the distribution of COVID-19 vaccines.

“A COVID-19 vaccine is a strategically valuable asset to nation-states; whoever gets a vaccine distributed first has an economic advantage. It is the ultimate IP with immediate value. It is like having an oil rush, a data advantage or territorial gain in older real political terms.”

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Top 20 Generics Pharma Companies Based On 2019 Revenue

The global generics pharmaceutical market has become an intimidating segment of the pharmaceutical drug market which continuously growing and increasing with its accessibility & benefits offered as efficient and economical drugs. Generics are approved copies of small molecule drugs that contain the same amount of active ingredients, dosage form, safety, strength, route of administration, quality, performance characteristics, as of originally marketed products. A report by Global Data says that Indian generic manufacturers are doing particularly well in the generic marketplace, and more and more companies are moving their manufacturing facilities overseas to cut costs. In the list of top 20 companies, Mylan reserved the top position with a revenue of $11.5B in 2019. Our team at PharmaShots has compiled a list of the top 20 generics developing companies based on their 2019 generics revenue.

Generic Segment Revenue: $0.24B

Founded Year: 1980

Market Cap: ~$4.41B

Total Employees: ~6,579

Headquarter: Mumbai, India

Stock Exchange: NSE

Piramal Healthcare is a global pharmaceutical company offering therapies focussed on CNS, cardiovascular, anti-infective, and anti-diabetic. Piramal Healthcare has generated a revenue of $0.24B in 2019 from its generic segment.

Generic Segment Revenue: $0.73B

Founded Year: 1867

Market Cap: ~$0.02B

Total Employees: ~3,400

Headquarter: Surrey, United Kingdom

Stock Exchange: OTCMKTS

Mallinckrodt is a global pharmaceutical company that develops and manufactures therapies for multiple therapy areas including autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology, immunotherapy, and neonatal respiratory critical care therapies, and analgesics. Mallinckrodt has generated a revenue of $0.73B in 2019.

Generic Segment Revenue: $0.87B

Founded Year: 1997

Market Cap: ~ $1.21B

Total Employees: ~3,172

Headquarter: Dublin, Ireland

Stock Exchange: NASDAQ

Endo International is an Ireland-based, global pharmaceutical company focusing on generic and branded pharmaceuticals for therapeutic areas that include Endocrinology, Medical Aesthetics, Orthopedics, Urology & Men’s Health. Endo’s Percocet (Oxycodone/acetaminophen) is an opioid analgesic approved for the treatment of moderate-to-moderately-severe pain. Endo has generated global sales of $0.87B in 2019.

Generic Segment Revenue: $1.05B

Founded Year: 1959

Market Cap: ~$6.13B

Total Employees: ~12,881

Headquarter: Ahmedabad, India

Stock Exchange: NSE

Torrent Pharma is a pharmaceutical company focused on developing therapies for Cardiovascular, Central Nervous System, GI, Vitamins Minerals Nutritionals (VMN), and Women’s Healthcare. The Company also has a focus on diabetology, pain management, gynecology, oncology, and anti-infective segments. Torrent has generated a sale of $1.05B from the generic portfolio in 2019.

Generic Segment Revenue: $1.20B

Founded Year: 1973

Market Cap: ~$124.6=06B

Total Employees: ~1,00,000

Headquarter: Paris, France

Stock Exchange: EPA

Sanofi is a leading global healthcare company, focused on patient needs and engaged in the research, development, manufacturing, and marketing of therapeutic solutions. The company is focused on Rare Diseases, Multiple Sclerosis, Immunology, Rare Blood Disorder, Oncology, Diabetes, Cardiovascular, Established Prescription Products, Generics, Consumer Healthcare, and Vaccines. Sanofi has generated $1.20B sale from its generic portfolio.

Generic Segment Revenue: $1.30B

Founded Year: 2002 

Market Cap: ~$1.26B

Total Employees: ~5,500

Headquarter: New Jersey, United States

Stock Exchange: NYSE

Amneal Pharmaceuticals is a global company developing and marketing generic and specialty drugs in multiple dosage forms for various diseases. The generic drug has generated a global sale of $1.30B in 2019.

Generic Segment Revenue: $1.41B

Founded Year: 1977

Market Cap: ~$2.02B

Total Employees: ~13,014

Headquarter: Mumbai, India

Stock Exchange: NSE

Glenmark is a global pharmaceutical company focusing on Generics, Specialty, and OTC business in therapy areas like Dermatology, Respiratory, and Oncology including Cardiology, Diabetes, and Oral Contraceptives. In 2019, Glenmark reported sales of $1.41B from its generic segment.

Generic Segment Revenue: $1.69B

Founded Year: 1929

Market Cap: ~$2.04B

Total Employees: ~2,568

Headquarter: Osaka, Japan

Stock Exchange: TYO

Sawai Pharmaceutical is a generic pharmaceutical focus on drugs for multiple therapy areas i.e. cardiovascular, antihyperlipidemic agents, diabetes drugs, anticancer drugs, and OTC drugs. Sawai Pharmaceutical has generated a revenue of $1.69B in 2019.

Generic Segment Revenue: $1.72B

Founded Year: 1895

Market Cap: NA

Total Employees: ~11,100

Headquarter: Bad Vilbel, Germany

Stock Exchange: NA

STADA is an international pharmaceutical company that focuses on Generics and Branded Products. Its branded portfolio includes non-prescription (OTC), prescription (RX), and discretionary prescription (OTX) products. Naxolone (Tilidin Naloxone) is a generic drug targeted for pain. STADA has generated worldwide sales of $1.72B from its generic segment in 2019.

Generic Segment Revenue: $1.83B

Founded Year: 1984

Market Cap: ~$11.32B

Total Employees: ~21,000

Headquarter: Telangana, India

Stock Exchange: NSE

Dr. Reddy’s Laborataries is a global pharmaceutical company with three divided segments Pharmaceutical Services & Active Ingredients, Global Generics, and Proprietary Products. The company focuses on GI, cardiovascular, diabetology, oncology, pain management, and anti-infective. In 2019, Dr. Reddy’s has recorded the sale of $1.83B from its generic segment.

Generic Segment Revenue: $2B

Founded Year: 1968

Market Cap: ~$5.80B

Total Employees: ~24,301

Headquarter: Mumbai, India

Stock Exchange: NSE

Lupin is a pharmaceutical firm involved in developing and delivering a wide range of generic formulations, biosimilar products, and APIs globally. The company holds the 3rd largest position as pharmaceutical-based on global revenue in India and 6th as a generic leader in Japan. The company is focused on multiple therapy areas including Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective, and NSAID space and holds a global leadership position for the Anti-TB segment. Lupin has generated total revenue of $2B from its generic segment in 2019.

Generic Segment Revenue: $2.20B

Founded Year: 1978

Market Cap: ~$7.63B

Total Employees: ~8,600

Headquarter: London, United Kingdom

Stock Exchange: LON

Hikma is a global pharmaceutical firm focusing on the development and marketing of generics, branded products, and injectables anti-infectives, cardiovascular, CNS, diabetes including oncology, pain management, and respiratory. The company’s generic segment has demonstrated the sale of $2.20B in 2019.

Generic Segment Revenue: $2.27B

Founded Year: 1935

Market Cap: ~$8.31B

Total Employees: ~26,000

Headquarter: Mumbai, India

Stock Exchange: NSE

Cipla is a global leading pharmaceutical company ranked at 10th position among the US firms. Cipla is a leading firm in generics that majorly focuses on Cardiology, Oncology, and Diabetology. In Apr’20 Cipla received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation from the FDA. In 2019, Cipla has generated a revenue of $1.79B from its generic segment.

Generic Segment Revenue: $3.06B

Founded Year: 1986

Market Cap: ~$7.09B

Total Employees: ~18,469

Headquarter: Telangana, India

Stock Exchange: NSE

Aurobindo Pharma Limited is a world-leading manufacturer of generic pharmaceuticals and active pharmaceutical ingredients. The company is focused on therapeutic/product areas encompassing Antibiotics, Antiretrovirals, CVS, CNS, Systemic Gastroenterologicals, Anti-Allergies, Anti-Diabetics, and other therapeutic areas. Aurobindo has generated a total sale of $3.06B in 2019 from its generic segment.

Generic Segment Revenue: $3.29B

Founded Year: 1996

Market Cap: ~$25.63B

Total Employees: ~2,94,134

Headquarter: Bad Homburg, Germany

Stock Exchange: ETR

Fresenius Kabi is a global healthcare company that develops and provides products as well as services for Dialysis, Generic & IV drugs, Biosimilars, Medical Devices in addition to Infusion and Nutrition therapies. Fresenius portfolio has around 90+ intravenously administered generic anesthetics, analgesics, anti-infectives, and drugs that treat multiple disorders. In 2019, the company has generated a total revenue of $3.29B from its generic sales.

Generic Segment Revenue: $4.28B

Founded Year: 1983

Market Cap: ~$18.33B

Total Employees: ~36,000

Headquarter: Mumbai, India

Stock Exchange: NSE

Sun Pharma is the world’s fourth-largest and India’s top generic pharmaceutical company. Sun Pharma’s manufacturing operations are focused on producing generics, branded generics, specialty products, over-the-counter products, anti-retroviral, and active pharmaceutical ingredients (APIs). Apart from this, the firm offers products for several therapy areas such as dermatology, psychiatry, neurology, cardiology, nephrology, gastroenterology, orthopedics, and ophthalmology. Sun Pharma has a pipeline of 98 ANDAs and 5 NDAs awaiting approval from the US FDA. Sun Pharma has reported a global sale of $4.28B in 2019.

Generic Segment Revenue: $9.32B

Founded Year: 1944

Market Cap: ~$11.67B

Total Employees: ~40,039

Headquarter: Petah Tikva, Israel

Stock Exchange: NYSE

Teva is a global pharmaceutical firm leading in generic products with a portfolio consisting of over 35,000 products in every therapy area. The products manufactured include a variety of dosage forms, including tablets, capsules, injectables, inhalants, liquids, ointments, and creams. Teva has generated a revenue of $9.32B in 2019.

Generic Segment Revenue: $9.73B

Founded Year: 1886

Market Cap: NA

Total Employees: ~26,500

Headquarter: Holzkirchen, Germany

Stock Exchange: NA

Sandoz, a Novartis division is a global leader in developing, manufacturing, and marketing finished dosage form medicines as well as intermediary products including active pharmaceutical ingredients. The company is organized globally into three divisions Retail Generics, Anti-Infectives, and Biopharmaceuticals. Sandoz is focused on therapies for Cardiovascular, CNS, Dermatology, Gastrointestinal & Hormonal disorders, Metabolism, Oncology, Ophthalmic pain, and Respiratory disorders. In 2019, Sandoz has generated revenue of $9.73B from its generic segment.

Generic Segment Revenue: $10.23B

Founded Year: 1849

Market Cap: ~$232.68B

Total Employees: ~83,000

Headquarter: New York, United States

Stock Exchange: NYSE

Pfizer is a research-based global biopharmaceutical company with a portfolio of Internal Medicine, Vaccines, Oncology, Inflammation & Immunology, Rare Disease, and Consumer Healthcare. Upjohn-Pfizer’s generic business unit has an off-patent branded and generic products business, headquartered in China includes approximately 20 off-patent solid oral dose brands as well as certain generic products. In 2019, Pfizer’s generic segment has generated a global sales revenue of $10.23B.

Generic Segment Revenue: $11.5B

Founded Year: 1961

Market Cap: ~21.57B

Total Employees: ~35000

Headquarter: Pennsylvania, United States

Stock Exchange: NASDAQ

Mylan is a global pharmaceutical company focused on manufacturing of prescription generic, branded generic, brand-name including biosimilar drugs and OTC drugs for multiple diseases. Mylan focuses on drugs that are challenging to formulate and manufacture and usually have longer product life cycles than usual generic pharmaceuticals. Mylan has generated a revenue of $11.5B in 2019 from its generic segment. In Sep’19 Mylan launched its Fulvestrant Injection (50 mg/mL)/single-dose prefilled syringe which is a generic version of AstraZeneca’s Faslodex Injection and has received FDA’s ANDA as monothx. for advanced BC in women with menopause and combination therapy for advance & m-BC.

Related Post: Top 20 Generics Pharma Companies Based On 2018 Revenue

The post Top 20 Generics Pharma Companies Based On 2019 Revenue first appeared on PharmaShots.

Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Shots:

  • Health Canada has granted authorization under interim order for the emergency use of BNT162b2. The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the NACI
  • BioNTech will hold the regulatory approval in Canada while Pfizer will have the commercialization rights. The approval is based on data that was filed through the rolling submission regulatory pathway and data from the P-l/ll clinical trial that began recruiting in Jul’2020 & enrolled ~44,000 patients across ~150 sites in multiple countries
  • The companies will supply ~20M doses of vaccine to Canada through 2021

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Bloomberg Quint

The post Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19 first appeared on PharmaShots.

Coronavirus vaccine may have allergy warning in US, says expert

The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions.

Moncef Slaoui, co-head of the US government’s Operation Warp Speed COVID-19 vaccine programme, made the comments after the UK drugs regulator advised those with severe allergies to avoid the vaccine.

According to press reports, Slaoui expects an influential FDA advisory committee to say today that people with severe allergies “should not take the vaccine until we know exactly what happened.”

According to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), people with a “significant history of allergic reactions” should avoid the shot.

This followed two NHS staff members, who both carried adrenaline auto-injectors and had a history of allergic reaction, developing an anaphylactoid reaction after receiving the vaccine on Tuesday.

These individuals developed symptoms of anaphylactoid reaction – a milder reaction than a severe anaphylactic shock – shortly after receiving the vaccine. Both recovered after appropriate treatment.

Professor Stephen Powis, national medical director for the NHS, said in a statement: “As is common with new vaccines the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday. Both are recovering well.”

It’s an issue that’s also likely to come up at today’s meeting of US vaccine experts, who are advising the FDA on whether to go ahead with an Emergency Use Authorization for the shot.

FDA reviewers have already concluded that the vaccine is safe and effective in a briefing document ahead of the Vaccines and Related Biological Products Advisory Committee’s meeting.

The committee will meet in public to discuss the shot and although the FDA is not bound to follow its advice, the regulator usually follows its experts’ advice when making decisions on drugs.

The regulator has run its own analysis of the vaccine and concluded there was a “slight numerical imbalance”, with more adverse events representing allergic reactions in those taking the vaccine compared with the placebo group.

There were 137 people reporting hypersensitivity-related adverse events in the vaccine group and 111 in the placebo group, according to the analysis in the briefing document.

This represented a tiny fraction of the 38,000 people tested in the phase 3 trial at the time of data read-out although the trials so far have excluded people with histories of allergic reactions.

Feature image copyright BioNTech SE 2020, all rights reserved

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NHS told not to give Pfizer vaccine to extreme allergy sufferers after two people have reaction

Anyone scheduled to receive vaccine will be asked about history of allergic reactions

Regulators have issued a warning that people who have a history of “significant” allergic reactions should not currently receive the Pfizer/BioNTech Covid-19 vaccine after two people who had the jab on Tuesday had allergic reactions.

Two NHS staff members who received the vaccine on the first day of the mass vaccination programme experienced an allergic reaction, the NHS in England has confirmed.

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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading.

The gist of a briefing document published from FDA reviewers ahead of an expert advisory board meeting is that the vaccine is good to go.

But there are still unanswered questions that can only be addressed once the shot is administered to the wider public.

Thursday’s vote of the Vaccines and Related Biological Products Advisory Committee is non-binding – but the FDA seldom takes a different viewpoint from its experts when it makes a final regulatory decision.

Pfizer and BioNTech are asking for an Emergency Use Authorization of their vaccine based on phase 3 data, which can be converted into a full licence at a later date once further trial information is published.

Phase 3 trials are designed to test whether vaccines are safe and effective and in this regard FDA reviewers said in the document that the Pfizer/BioNTech vaccine is a success, effective in around 95% of cases and with “favourable safety profile”.

The most common adverse reactions seen in a trial cohort of 38,000 patients were at injection sites (84.1%) followed by fatigue (62.9%) and headache (55.1%), and serious adverse reactions occurred in 0% to 4.6% of participants.

There were four cases of Bell’s palsy – a sudden muscle weakness – in the vaccine group and none in a placebo arm.

However the FDA noted there are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating women, and those with compromised immune systems.

The biggest issue for the FDA staffers is one that will only be resolved with time – whether or not the shot can prevent people from infecting each other.

Reviewers said that “additional evaluations including data from clinical trials and from vaccine use post-authorisation will be needed to assess the effect of the vaccine in preventing virus shedding and transmission, in particular in individuals with asymptomatic infection”.

Reviewers noted there was no evidence of “vaccine-enhanced disease” but whether the vaccine could lead to a more resistant strain of the virus emerging is also unclear.

The regulator will be keeping a watching brief on this as more study data emerges over the course of the pandemic.

This risk “needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorisation and/or licensure,” reviewers said.

Hospitals in the UK have already begun immunising high-risk patients after the country’s regulator became the first in the world to approve the Pfizer/BioNTech vaccine last week.

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Nine out of 10 in poor nations to miss out on inoculation as west buys up Covid vaccines

Billions unlikely to get jabs as rich countries secure 53% of most promising vaccines

Nine out of 10 people in 70 low-income countries are unlikely to be vaccinated against Covid-19 next year because the majority of the most promising vaccines coming on-stream have been bought up by the west, campaigners have said.

As the first people get vaccinated in the UK, the People’s Vaccine Alliance is warning that the deals done by rich countries’ governments will leave the poor at the mercy of the rampaging virus. Rich countries with 14% of the world’s population have secured 53% of the most promising vaccines.

Continue reading…

FDA: Pfizer Covid vaccine data fits with guidance on emergency authorization

Comments raise hopes that the vaccine could soon be available to Americans aged 16 and above

US Food and Drug Administration (FDA) staff said on Tuesday that data on Pfizer’s coronavirus vaccine was in line with its guidance on emergency use authorization, raising hopes it could soon be available to Americans aged 16 and above.

The comments were made in documents released ahead of Thursday’s meeting of outside experts to discuss whether the vaccine developed by Pfizer with German pharmaceutical partner BioNTech should be authorized for emergency use in America.

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First COVID-19 vaccinations begin in UK hospitals

A 90-year-old woman has become the first person given a COVID-19 vaccine as part of the UK’s mass vaccination programme.

Margaret Keenan was given the injection at 06:31 this morning at University Hospitals Coventry and Warwickshire NHS Trust.

Keenan turns 91 next week and the BBC said she described receiving the shot as “the best early birthday present”.

It was the first of 800,000 doses of the Pfizer/BioNTech vaccine that will be given in the coming weeks, and up to four million more are expected by the end of the month.

The logistical challenges of storing and distributing the vaccine, which must be kept at around -70C to retain its integrity, mean that distribution will occur at around 50 hubs nationally.

Keenan said: “I feel so privileged to be the first person vaccinated against COVID-19, it’s the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the New Year after being on my own for most of the year.

“My advice to anyone offered the vaccine is to take it – if I can have it at 90 then you can have it too!”

NHS nurse May Parsons said it was a “huge honour” to be the first in the country to deliver the vaccine to the patient.

NHS England chief executive Sir Simon Stevens added: “Less than a year after the first case of this new disease was diagnosed, the NHS has now delivered the first clinically approved COVID-19 vaccination – that is a remarkable achievement.

“Today is just the first step in the largest vaccination programme this country has ever seen. It will take some months to complete the work as more vaccine supplies become available and until then we must not drop our guard.

“But if we all stay vigilant in the weeks and months ahead, we will be able to look back at this as a decisive turning point in the battle against the virus.”

The vaccine has also been given to the first person in Wales, where 48 year-old Craig Atkins from Ebbw Vale became the first to receive the shot.

Wales has been hit badly by the virus and unlike England the numbers of cases are continuing to rise, prompting the country’s devolved government to consider a third national lockdown as hospital cases rose to a record high.

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UK faces “V-Day” and largest ever vaccination programme

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial.

Health secretary reportedly Matt Hancock came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history.

The UK last week became the first country in the world to officially authorise the vaccine, which has so far shown an effectiveness of around 95% and minimal side effects in a late-stage clinical trial.

But the logistics of delivering the vaccine are hugely challenging, with up to 4 million sent out this month alone.

The most at-risk groups of people will be first to get the vaccine, with people in care homes, those aged over 80 and healthcare workers targeted first.

On top of this is the requirement for the cutting-edge RNA-based vaccines to be stored at ultra-low temperatures.

According to Luxembourg-based cold chain specialist B Medical Systems, demand for ultra-cool freezers has gone “off the chart” in recent weeks.

Pfizer’s vaccine needs to be stored at around -70C to retain its integrity, while its rival from Moderna that is under review by regulators needs to be stored at -20C.

The company has developed a product that can operate as both a vaccine freezer and a vaccine refrigerator, which could be used to store the Pfizer/BioNTech and Moderna vaccines, as well as the potential shot from AstraZeneca that requires standard refrigerator temperatures for storage.

However the waiting list for the vaccine fridges is expected to grow as more and more companies authorise various coronavirus vaccines.

CEO Luc Provost said: “Normally we would be supplying 2,000-3,000 units typically for a country. We expect this to increase 5-7 fold to some 15,000 units at least. In places like India we are seeing orders reach six figures.”

The biggest challenge is maintaining an unbroken “cold chain”, something that is already common in medicine logistics, but more challenging on this occasion because of the specialist requirements of the vaccine and the sheer scale of the operation.

According to Provost the biggest challenge will be distribution within the UK and other countries and in particular “the last mile” to the patient.

“Vaccine wastage happens in two areas – in-country transport and vaccine administration at health facilities.

“Most portable vaccine carriers and cold containers cannot keep cold beyond 12 hours, especially if it is hot outside.

“Transportation for the last mile to where the immunisation is happening – for example care home residents which will be amongst the first in the UK to get vaccinated – is time consuming and monitoring this journey presents a big problem.”

Feature image copyright BioNTech SE 2020, all rights reserved

 

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Covid vaccine arrives in UK hospitals ready for first jabs

Medical director warns of great hurdles in largest vaccination campaign in UK history

Batches of the Covid vaccine have begun to arrive in hospitals around the UK, ready for the first jabs on Tuesday in what NHS England’s medical director warned would be the largest and most complex vaccination campaign in the country’s history.

The UK’s record-breaking approval of the vaccine and the rapid start of immunisation against Covid-19 did not mean the end of the pandemic was in sight, said Prof Stephen Powis. It would be a marathon and not a sprint, he said.

Related: How does the Pfizer/BioNTech vaccine work and who will get it?

Related: How vaccine approval compares between the UK, Europe and the US

Continue reading…

Covid-19 vaccine ‘very safe and highly effective’, UK health chief says

Vaccine safety message ‘vitally important’, head of medicines regulator tells Andrew Marr Show

Public health messaging that people can have faith in the safety of coronavirus vaccines is “vitally important”, the leader of the body that has approved the Pfizer jab has said.

Dr June Raine, the chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), said of the Pfizer treatment that there “should be no doubt whatever that this is a very safe and highly effective vaccine”.

Related: The vaccine miracle: how scientists waged the battle against Covid-19

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The vaccine miracle: how scientists waged the battle against Covid-19

We trace the extraordinary research effort, from the discovery of the virus’s structure to the start of inoculations this week

In the early afternoon of 3 January this year, a small metal box was delivered to the Shanghai Public Health Clinical Centre addressed to virus expert Prof Zhang Yongzhen. Inside, packed in dry ice, were swabs from a patient who was suffering from a novel, occasionally fatal respiratory illness that was sweeping the city of Wuhan. Exactly what was causing terrifying rises in case numbers, medical authorities wanted to know? And how was the disease being spread?

Related: ‘I worked so hard in the lab. I cried when the news came’

What Zhang did was critical … Without the information he provided no one could have started working on vaccines

Related: Team behind Oxford Covid jab start final stage of malaria vaccine trials

Related: NHS staff no longer at front of queue for Covid vaccine after rethink

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Covid vaccines offer chance for big pharma to improve its image

They make life-saving medicines, but no one likes them. Could this year be a turning point?

Never before has the world awaited a new medicine with such bated breath. A vaccine for Covid-19 has the potential to unlock society and save millions of people from death and serious disease, and the hero of the hour is an industry that is often regarded with disdain.

“Traditionally and historically, public trust in pharma has been comparable to the trust they put in their broadband provider,” said Alex Davies, a healthcare PR expert at Hanover Communications, which counts many drug companies as clients.

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PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M

Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC

Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, Jazz Pharma, P-III, patients, PharmaMar, results, SCLC, study, Zepzelca

reMYND Commences P-l Study of RES19-T for Alzheimer’s Disease

Published: Dec 3, 2020 | Tags: Alzheimer, Commencement, First-in-Human, P-l, reMYND, RES19-T, Treatment, Trial

Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes

Published: Dec 2, 2020 | Tags: Abbott, Adults, approval, canada, Children, Diabetes, FreeStyle Libre 2, health, receives

Exactech Acquires Muvr and its Digital Health Tech for Orthopedic Practices

Published: Dec 2, 2020 | Tags: Acquires, Exactech, Muvr Labs, Orthopedic

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Published: Dec 3, 2020 | Tags: Janssen, Reports, BLA Submission, Amivantamab, US FDA, Metastatic NSCLC, EGFR Exon 20 Insertion Mutations

Merck KGaA Collaborates with Artios Pharma for DNA Damage Cancer Therapies

Published: Dec 3, 2020 | Tags: Agreement, Artios Pharma, Damage, DNA, Merck KGaA, Novel, Oncology, Response, Signs, Targets

Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

Published: Dec 2, 2020 | Tags: Acquires, Age Related Macular Degeneration, Biosciences, Gene, Hemera, Janssen, Late, Novel, Pioneering, Rights, Solutions, Stage, therapy, Treatment

AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS

Published: Dec 3, 2020 | Tags: AstraZenca, DESTINY-Breast01, Enhertu, HER2 -Positive Metastatic Breast Cancer, HR, P-l, P-ll, reports, results, SERD AZD9833, SERENA-1 Study

AbbVie Collaborates with Frontier Medicines to Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets

Published: Dec 2, 2020 | Tags: AbbVie, Agreement, Develop, Discover, E3 Degraders, Frontier Medicines, Novel Therapies, Sign

Roche’s Elecsys Anti-SARS-CoV-2 S Receives the US FDA’s EUA to Detect Ab Against SARS-CoV-2 Spike Protein

Published: Dec 2, 2020 | Tags: (Anti-SARS-CoV-2 S), COVID-19, Elecsys, EUA, Receive, Roche’s, US FDA’s

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Published: Dec 2, 2020 | Tags: Against, BioNTech, BNT162b2, COVID-19 COVID-19, EUA, MHRA, Pfizer, receives, Regulatory, UK

Roche’s Gavreto (pralsetinib) Receives the US FDA’s Approval for Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers

Published: Dec 2, 2020 | Tags: (pralsetinib), Advanced or Metastatic RET-Mutant, Gavreto, receives, RET Fusion-Positive Thyroid Cancers, Roche’s, US FDA’s Approval

AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M

Published: Dec 1, 2020 | Tags: $350M, Acquire, Agreement, AstraZeneca, CRESTOR, European, Grünenthal, Rights, rosuvastatin, Signs

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform

Published: Dec 1, 2020 | Tags: Casirivimab, Collaborates, COVID-19 Antibody Cocktail, Delivery, Gene Therapy Platform, Imdevimab, Investigate, Penn, Regeneron

Boston Scientific to Divest BTG’s Specialty Pharma Business for ~$800M

Published: Dec 1, 2020 | Tags: Agreement, Boston, BTG, business, International, Pharmaceuticals, Scientific, Sell, Signs, Specialty, Stark

BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19

Published: Dec 1, 2020 | Tags: application, BioNTech, BNT162b2, CMA, Covid-19 Vaccine, EMA, Pfizer, Submitted

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Published: Dec 1, 2020 | Tags: Adults, approval, Genentech Xolair, Nasal Polyps, Novartis, omalizumab, receives, US FDA

Eisai Sign a Research Agreement with Wren Therapeutics to Discover Potential Treatment for Synucleinopathies

Published: Nov 30, 2020 | Tags: Discover, Eisai, Novel Small Molecule, Research Agreement, Sign, Synucleinopathies, Wren Therapeutics

 AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol

Published: Nov 30, 2020 | Tags: Antisense, AstraZeneca, Initiates, ION449, Ionis, LDL-C, Lower, Medicine, P-IIb, PCSK9, reports, study, Targeting

Kaia Health Allied with Chiesi Group to Commercialize COPD App in Europe

Published: Nov 30, 2020 | Tags: Agreement, Chiesi Group, Europe, Kaia Health, Sign

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study

Published: Dec 1, 2020 | Tags: Amgen, COMMUNITY, COVID-19, enrolled, First, Patient, patients, reports, Takeda, Trial, UCB

Sanofi’s Dupixent (dupilumab) Receives EC’s Approval for Children with Severe Atopic Dermatitis

Published: Nov 30, 2020 | Tags: (dupilumab), Atopic Dermatitis, Dupixent, European Commission Approval, receives, Sanofi’s

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

Published: Nov 30, 2020 | Tags: 100%, 94.1%, COVID-19, Effective, EUA, Filing, Moderna, mRNA, Severe, Shows, Today, Us FDA, vaccine

AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure

Published: Nov 30, 2020 | Tags: approval, AstraZeneca, Chronic Heart Failure, dapagliflozin, Forxiga, Japan, MHLW, receives, Treatment

AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum

Published: Nov 27, 2020 | Tags: (adalimumab), AbbVie, Additional, Eisai, Humira, Indication, MHLW Approval, Pyoderma Gangrenosum, receives

Shionogi and Nagasaki University Collaborate with the Kitasato Institute for Antimalarial Drugs

Published: Nov 25, 2020 | Tags: Agreement, Antimalarial, drugs, Kitasato Institute, Nagasaki, Shionogi, Signs, University

Shionogi Receives MHLW’s Approval for Xofluza’s sNDA to Treat Post-Exposure Prophylaxis of Influenza Virus Infection

Published: Nov 27, 2020 | Tags: (baloxavir marboxil), approval, Infection, Influenza Virus, MHLW, Post-Exposure Prophylaxis, receives, Shionogi, sNDA, Treat, Xofluza

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Published: Nov 29, 2020 | Tags: 2M, Additional, Against, Agreement, Amends, COVID-19, doses, Government, Moderna, mRNA, mRNA-1273, UK, vaccine

Dr. Reddy’s to Divest Select Anti-Allergy brands to Dr. Reddy’s in Russia and Other CIS Countries

Published: Nov 28, 2020 | Tags:  Acquire, Dr. Reddy, Glenmark, Kazakhstan, Russia, Ukraine, Uzbekistan

Related Post: PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

The post PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020) first appeared on PharmaShots.

Valneva accelerates Lyme disease vaccine R&D project with Pfizer

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021.

Subject to approval from regulators the vaccine specialist said it plans the trial known as VLA15-221 as a randomised, observer-blind phase 2 study including around 600 healthy people aged 5-65 years of age.

They will receive VLA15 at the dose of 180 micrograms, which was selected based on data from two ongoing phase 2 studies.

First data from the study is expected by the second quarter of 2022 and all three studies will support a phase 3 pivotal efficacy trial including all main target populations for the Lyme vaccine, starting in 2022.

Starting the next phase 2 study will trigger a milestone payment from Pfizer to Valneva of $10 million under a collaboration announced in April this year.

Under the agreement Valneva could receive up to $308 million in cash payments, after Pfizer paid $130 million up front for marketing rights to the vaccine if it succeeds in the clinic.

Pfizer will pay up to $45 million in development related milestone payments and up to $143 million if the vaccine hits early sales targets.

Valneva is paying 30% of development costs and in return Pfizer will pay tiered royalties starting at 19% and will lead late-stage development.

VLA15 is the only active Lyme disease vaccine in clinical development today, and covers six strains that are prevalent in North America and Europe.

This investigational multivalent protein subunit vaccine targets the outer surface protein A (OspA) of the bacterium Borrelia that causes the disease, an established mechanism of action for a Lyme disease vaccine.

OspA is one of the most dominant surface proteins expressed by the bacteria when present in the ticks that spread the disease.

VLA15 has demonstrated a promising immune response and safety data in pre-clinical and clinical studies so far.

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Pfizer cut vaccine production targets because of raw material shortage – reports

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports.

The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.

That’s enough to inoculate 25 million people as the dosing schedule involves two shots three weeks apart.

A Pfizer spokesperson told Reuters that the “scale-up of the raw material supply chain took longer than expected”.

Results from Pfizer’s clinical trial also took longer than expected to materialise and caused further delays, the spokesperson added.

Modifications to Pfizer’s production lines are complete and finished doses are being made at a rapid pace.

The Wall Street Journal reported the news first, quoting an unnamed source directly involved in the development that some early batches of raw materials had failed to meet standards, causing production delays.

The first shipments of the vaccine are reportedly in the UK following approval by the country’s medicines regulator.

Pfizer has asked the FDA for an emergency authorisation of the vaccine in the US and the US government expects to the first tranche to include about 6.4 million doses.

In a separate announcement, rival vaccine firm Moderna said it expected to have between 100 and 125 million doses available globally in the first quarter of 2021.

Of those 85-100 million will be available in the US and 15-25 million will be available outside the US.

The company said it is still on course to manufacture between 500 million and up to a billion doses of the vaccine globally in 2021.

Moderna’s vaccine is also under review by regulators including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The UK has secured 7 million doses of Moderna’s vaccine after upping its order by 2 million earlier this week.

This could mean the UK could have access to up to 357 million doses of vaccines from seven different developers if they are all approved by regulators.

There are now more than 50 vaccines in clinical development and more than a dozen in late-stage trials, according to a regularly updated document from the World Health Organization.

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Insights+ Key Biosimilars Events of November 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties. During the month of November, Formycon and Bioeq reported the first patient dosing in the P-III study of FYB202 while Prestige collaborated with Teva to commercialize Tuznue. Our team at PharmaShots has summarized 21 key events of the biosimilar space of Nov 2020.

Celltrion Presented Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Published: Nov 03, 2020

Product: CT-P17 (biosimilar, adalimumab)

  • The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
  • Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
  • Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS)

Formycon Reported BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Published: Nov 06, 2020

Product: FYB201 (biosimilar, ranibizumab)

  • Formycon & Bioeq reported the BLA resubmission strategy for FYB201 (biosimilar referencing Lucentis) has been adjusted
  • With the revised submission strategy, the companies expect a simplification of the approval procedure. The modified submission dossier is anticipated to be filed with the US FDA in H1’21
  • The adjustment of the regulatory strategy while optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US & EU

Formycon and Bioeq Reported First Patient Dosing in P-III Study of FYB202 (biosimilar, ustekinumab)

Published: Nov 09, 2020

Product: FYB202 (biosimilar, ustekinumab)

  • The focus of the P-III study is to demonstrate the comparability of FYB202 & the reference product Stelara in terms of efficacy, safety & immunogenicity in patients with moderate to severe psoriasis vulgaris
  • FYB202 is being developed as part of JV b/w Aristo Pharma & Formycon along with Bioeq. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US FDA & the EMA
  • The ustekinumab is mAb targeting the cytokines IL-12 & IL-23. Stelara is used to treat various severe inflammatory conditions such as mod. to sev. psoriasis, CD & for UC

Alvotech and Cipla Collaborated to Ensure Access to Biosimilars in South Africa

Published: Nov 09, 2020

Product: Biosimilar

  • Alvotech and Cipla entered an exclusive partnership to provide patients with better access to high quality and cost-effective biosimilar medicines in South Africa
  • Alvotech will be responsible for the development and supply of the products and Cipla will be responsible for the registration and commercialization
  • The biosimilar portfolio will include five biosimilars- two for oncology and three for treating auto-immune diseases

Genentech Filed Complaint Against Centus Over Proposed Bevacizumab Biosimilar

Published: Nov 13, 2020

Product: Proposed Bevacizumab Biosimilar

  • Genentech filed a complaint in the Eastern District of Texas alleging that the proposed biosimilar to Avastin (bevacizumab) product infringes 10 US patents
  • Genentech alleges that Centus and partners failed to disclose sufficient information about the proposed biosimilar to enable Genentech to do a sufficient analysis of potential patent infringements
  • Centus has a BLA under review with the FDA for the bevacizumab biosimilar candidate FKB238, and the company has filed a notice of intent to commercialize the agent

Prestige Signed an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Published: Nov 11, 2020

Product: Tuznue (biosimilar, trastuzumab)

  • Teva to get an exclusive right to commercialize Tuznu in Israel, leveraging its marketing capabilities and experience in bringing pharmaceutical products to market and will be responsible for local registration, sales, and marketing in Israel
  • Prestige will assume responsibility for product registration with the EMA and commercial supply of Tuznue from its manufacturing facilities in Osong, Korea
  • Tuznue is biosimilar referencing Roche’s Herceptin (trastuzumab), used to treat HER2-overexpressing BC & m-gastric adenocarcinoma. Additionally, the EMA has accepted an MAA for Tuznue based on the global clinical trial results

Samsung Bioepis Initiated P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Nov 11, 2020

Product: SB16 proposed biosimilar to Prolia

  • The P-I study assesses the PK/PD, safety, tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be 3 arms study that involves dosing with SB16 either the EU or US-sourced Prolia
  • The proposed biosimilar references Amgen’s Prolia which was approved in 2010 for osteoporosis with a high risk of fracture
  • With the initiation, Samsung Bioepis continues to advance its biosimilar portfolio covering immunology, oncology, ophthalmology, and hematology

Henlius Reported First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

Published: Nov 11, 2020

Product: HLX14 (denosumab, biosimilar)

  • The first patient has been dosed in a P-I study of HLX14, conducted in 2 parts, Part 1 is a pilot study assessing PK/PD, safety, tolerability & immunogenicity of HLX14 vs EU-sourced denosumab (SC) in healthy male volunteers
  • Part 2 is a four-arm study assessing the bioequivalence of HLX14 vs US-, EU-, CN-sourced denosumab. The study also evaluates PD, safety, tolerability, and immunogenicity between HLX14 and the reference drug
  • Results from the P-I study will provide reference for the dosing scheme in the clinical studies of HLX14

Xbrane Reported Patient Enrollment Completion in P-lll XPLORE Study of Xlucane (biosimilar, ranibizumab)

Published: Nov 11, 2020

Product: Xlucane (biosimilar, ranibizumab)

  • Xbrane reported that the last patient has been enrolled into the P-III XPLORE study assessing Xlucane vs Lucentis in 580 patients with wet AMD
  • The company will conduct an interim read-out from the XPLORE study when the last patient has reached 6mos. of their treatment schedule. Top-line data is expected to be communicated mid-2021 and filing of the MAA/BLA to EMA and the US FDA anticipated to take place imminently
  • Filing of MAA/BLA is expected to take place mid-2021. With an expected 12mos. regulatory process upon filing, MAA is expected in the EU and the US mid-2022 allowing for the launch of Xlucane

Henlius Reported the NMPA’s Acceptance of HLX15 (biosimilar, daratumumab) to Treat Multiple Myeloma

Published: Nov 16, 2020

Product: HLX15 (biosimilar, daratumumab)

  • The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment
  • The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
  • The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products

Samsung Bioepis Presented Results of SB11 Proposed Biosimilar to Lucentis in P-III Study at the AAO 2020 Virtual

Published: Nov 16, 2020

Product: SB11 proposed biosimilar to Lucentis

  • The P-III study involves assessing SB11 vs reference ranibizumab in monthly injections (0.5 mg) in 705 patients in a ratio (1:1) with nAMD while only 634 patients continued to receive treatment up to 48wks.
  • One-year results from the P-III study demonstrated equivalence between SB11 and reference ranibizumab in patients with nAMD
  • The study met its 1EPs i.e. changes from baseline in BCVA @8wks. and CST @4wks. The EMA has accepted for review the MAA of SB11 in Oct’2020

Samsung Bioepis and Biogen Reported the FDA’s Acceptance of BLA for SB11 Proposed Biosimilar to Lucentis

Published: Nov 18, 2020

Product: SB11 proposed biosimilar to Lucentis

  • The US FDA has accepted for review the BLA of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
  • The EMA has accepted for review the MAA of SB11 in Oct’2020. If approved, SB11 will add to the biosimilars portfolio developed under the collaboration of Samsung Bioepis and Biogen including Benepali, Imraldi & Flixabi
  • In Nov’2019, Samsung Bioepis entered into a commercialization agreement with Biogen for 2 ophthalmology biosimilar candidates, SB11 (ranibizumab) & SB15 (aflibercept) in the US, Canada, Europe, Japan & Australia. Ranibizumab is an anti-VEGF therapy for retinal vascular disorders

The US FDA Draft New Guidelines for Biosimilarity and Interchangeability

Published: Nov 19, 2020

Product: Biosimilar

Shots:

  • The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
  • The draft guidance is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as describe FDA’s interpretation of statutory requirements added by the BPCI Act
  • The draft guidance is to be published in the Federal Register on Nov 20, 2020

Alvotech Reported the US FDA and EMA’s Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab)

Product: Nov 20, 2020

Product: AVT02, a proposed biosimilar to Humira

  • The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4’21
  • The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of similarity b/w AVT02 and the reference products. AVT02-GL-101 study met its 1EPs of PK similarity while the later study confirmed the efficacy and safety of AVT02 in patients with mod. to sev. chronic psoriasis
  • AVT02 is a proposed biosimilar to the reference product Humira (adalimumab) with high concentration (100mg/mL) dosage forms

Henlius Presented Results of HLX04 (biosimilar, bevacizumab) in P-III Study at ESMO Asia 2020

Published: Nov 20, 2020

Product: HLX04 (biosimilar, bevacizumab)

  • The P-III HLX04-mCRC03 study involves assessing the efficacy, safety and immunogenicity of HLX04 vs reference bevacizumab (7.5 mg/kg, q3w or 5 mg/kg, q2w) + CT (Xelox or mFOLFOX6) as a 1L treatment in patients in the ratio of (1:1) with mCRC
  • Result: PFSR36wk (46.4% vs 50.7%); no significant difference b/w the treatment groups in 2EPs including OS, PFS, ORR, TTR and DoR; safety and immunogenicity profiles were similar b/w HLX04 and the reference
  • The NMPA has accepted the NDA for HLX04. Additionally, Henlius has submitted a patent for a new formulation of HLX04 with potential better safety and stability, designed for ophthalmic use

Samsung Biologics and AstraZeneca Dissolved Rituximab Alliance

Published: Nov 20, 2020

Product: SAIT101 (biosimilar, rituximab)

  • Samsung Biologics and AstraZeneca had decided to suspend long-running research and development activities by a jointly owned subsidiary, Archigen Biotech, which was solely engaged in development of SAIT101 (biosimilar, rituximab)
  • Samsung halted the P-III study of SAIT101 in Oct’2012 and resumed it in 2014 via Archigen. The P-III study similar therapeutic effect to Rituxan in 315 FL patients with ORR (66.3% vs 70.6%)
  • The companies decided to stop commercializing SAIT101 and take step for liquidation of Archigen as the product lacks commercial viability

The US FDA Approved Pfizer’s Oncology Supportive Care Biosimilar Nyvepria (biosimilar, pegfilgrastim)

Product: Nov 20, 2020

Product: Nyvepria (biosimilar, pegfilgrastim)

  • The EC has approved Nyvepria, a biosimilar referencing Neulasta to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic CT for malignancy
  • The EC approval is based data demonstrating a high degree of similarity of Nyvepria to its reference product
  • Pfizer plans to make Nyvepria available to patients in multiple EU countries starting in Q1’21. The EC’s approval follows the US FDA’s approval granted in Jun’2020

Innovent Reported Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Product: Nov 23, 2020

Product: Byvasda (biosimilar, bevacizumab)

  • The P-lll ORIENT-32 study involves assessing of Tyvyt (sintilimab) + Byvasda vs sorafenib as a 1L treatment in 571 patients in a ratio (2:1) with advanced HCC and the result were released in an oral presentation at the ESMO Asia Virtual Congress 2020
  • Result: Reduction in risk of all-cause mortality (43.1%); the median OS (not reached vs 10.4 mos.); reduction in risk of progression (43.5%); m-PFS (4.6 vs 2.8 mos.), results was presented at ESMO 2020
  • The improved OS and PFS benefits of the dual regimen were generally consistent across all subgroups and showed an acceptable safety profile with no new safety signals

Innovent’s Sulinno (biosimilar, adalimumab) Received NMPA’s Approval for Polyarticular Juvenile Idiopathic Arthritis

Published: Nov 23, 2020

Product: Sulinno (biosimilar, adalimumab)

  • The NMPA has approved Sulinno for the treatment of pJIA which is the fourth approved indication of the therapy in China. Earlier, Sulinno was approved for RA, PS, and psoriasis
  • The launch of Sulinno has provided more Chinese patients with high-quality and relatively affordable adalimumab injection, bringing hope and opportunities to more patients
  • Sulinno is a human anti-TNF-α mAb referencing Humira. The clinical results were published at the Inaugural Issue of The Lancet Rheumatology in 2019

Alvotech and Alvotech & CCHT Signed an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

Product: Nov 25, 2020

Product: Biosimilar

  • The companies collaborate with the Yangtze to commercialize eight biosimilars in China. The initial pipeline contains biosimilar candidates for the treatment of autoimmunity, ophthalmology, and oncology
  • Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China while Yangtze River Pharmaceutical will exclusively commercialize the biosimilars
  • The manufacturing of biosimilars will be made in a new state-of-the-art biopharmaceutical facility, currently being built in Changchun, China, through the Alvotech & CCHT. The first phase of the facility is expected to be completed in 2021

Bio-Thera Reported MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Product: Nov 26, 2020

Product: BAT1706 (a proposed biosimilar to Avastin)

  • The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein
  • The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma of the colon or rectum and NSCLC is under NMPA’s review
  • The company plans to submit a BLA for BAT1706 to the US FDA by the end of 2020. Bevacizumab is a mAb that targets VEGF thus reduces neovascularization, thereby inhibiting tumor growth

Related Post: Insights+ Key Biosimilars Events of October 2020

The post Insights+ Key Biosimilars Events of November 2020 first appeared on PharmaShots.

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Shots:

  • Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI
  • The MHRA’s decision is based on a rolling submission, including data from the P-III study, demonstrating 95% efficacy in participants without & with/ out prior SARS-CoV-2 infection, in each case measured from 7 days after the second dose
  • This marks the first EUA following a WW P-III trial of a vaccine to combat the pandemic. The companies are anticipating further regulatory decisions across the globe in Dec’2020

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: The Jakarta Post

The post Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19 first appeared on PharmaShots.

Social media erupts as anti-vaxxers respond to COVID-19 vaccine approval

In the midst of the jubilation about the UK’s emergency approval of Pfizer/BioNTech’s COVID-19 shot in the UK came the depressingly inevitable round of anti-vaccine social media activity and lobbying.

The green light for BNT162b was swiftly followed by posts on Twitter likening the vaccine to thalidomide – the drug that notoriously resulted in thousands of children being born with birth defects in the 1960s.

That ignores the fact that the thalidomide tragedy itself was responsible for the introduction of evidence-based medicine and reforms to the regulatory system that keep patients safe today.

While thalidomide is trending in the UK, it’s worth noting that many tweets are being posted by people slamming the #antivaxxers – a hashtag that is currently also riding high.

The Medicines and healthcare products regulatory Agency (MHRA) has been warning for some against anti-vaccine rhetoric that it fears could derail the coronavirus vaccination programme – which would be larger than any adult campaign carried out to date.

Pre-empting the backlash, MHRA’s chief executive Dr June Raine said at a Downing Street press briefing that despite the speed of its review, completed just three weeks after the final data were made available, no corners had been cut.

The vaccine had been approved after “an extremely thorough and scientifically rigorous review of all the evidence of safety, of effectiveness and of quality,” she asserted, adding: “The safety of the public will always come first.”

As the vaccine starts to be distributed, the National Institute for Biological Standards and Control (NIBSC) will be carrying out independent lab tests to confirm that every single shot that goes out meets the required standards for safety and quality, according to Raine.

Anti-vaxxers have been responsible for promulgating a series of fantastical rumours and conspiracy theories about coronavirus vaccines, including a persistent claim that vaccination will result in people being implanted with a microchip that will be used to track them.

Other false claims are that RNA-based vaccines like BNT162b can alter a recipient’s DNA and that the shots will contain tissue from aborted foetuses.

While some of these are frankly comical, the fear is that the spread of misinformation into mainstream media sources could result in fewer people taking up the opportunity to be vaccinated, undermining the programme.

Research published by the Vaccine Confidence Project – a unit of the London School of Hygiene & Tropical Medicine – found that misinformation around a COVID-19 vaccine induced a fall in the willingness to receive it among those who would otherwise “definitely” vaccinate.

VCP’s study found that only 54% of UK people would definitely have a COVID-19 vaccine – higher than the 41% seen in the US – with most of those who were reluctant citing safety concerns or a sense the threat posed by the pandemic had been overblown.

That’s already fewer than is required for herd immunity – a level of protection that would impact on virus transmission – but most worrying was that exposure to misinformation reduced the proportion of those definite responses by more than 6%.

“I hope that enough people take these vaccines, but I think it is going to be much more of a challenge than is recognised,” VCP director Heidi Larson told the Financial Times this week.

Speaking to the BBC today, Pfizer’s country manager for the UK, Ben Osborn said that “after the provision of clean water, vaccines are…the single most effective public health intervention we can make”. He also stressed that the study behind the approval was assessed by an independent panel with no links to Pfizer and BioNTech.

Health secretary Matt Hancock has also responded to questions about the anti-vax movement today, telling LBC radio that “the good news is that it’s not growing”.

“We monitor this very carefully and actually the number of people who want to have the vaccine is increasing,” he said

“The regulators are fiercely independent – they would not approve this if it wasn’t safe.”

800,000 doses of BNT162b have passed batch testing and should be ready within the next few days, and will be prioritised for elderly people in care homes and care home staff, followed by over-80s and health and care service workers.

The UK has ordered 40 million doses – enough for 20 million people – with several million doses expected to be available by year-end. Scottish leader Nicola Sturgeon said the first vaccines would be available in Scotland from Tuesday next week.

Twitter has also seen a debate about how the UK was able to become the first country in the world to approve the vaccine.

Hancock said the country was able to move quickly because of Brexit, but Raine emphasised in the press briefing that the approval was “made under provisions under European law which exist until January 1”.

The European Medicines Agency will meet on 29 December to decide if the safety and efficacy of Pfizer and BioNTech’s vaccine supports its approval.

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A history of Pfizer

Few companies embody the term ‘pharma giant’ as much as Pfizer. Here we take a look at the colourful history of one of the biggest drugmakers in the world.

Pfizer was founded in 1849 by two recent German immigrants to the USA, Charles Pfizer and Charles Erhart. Both in their mid-twenties, the two men set up what was initially a fine chemicals business in a Brooklyn factory, using a loan from Pfizer’s father as capital. The company’s first product, a palatable anti-parasitic drug, made to taste like toffee, united Pfizer’s skills as a chemist with Erhart’s training as a confectioner. It was a success, and set the pattern for the company’s future development.

Pfizer’s Tokyo building

The convulsion of the American Civil War, which broke out soon after in 1862, had as much of an impact on the nascent pharmaceutical industry as on American society in general. The “first industrial war” involved drug producers as much as weapons manufacturers. Like their competitor Squibb, the sudden need for enormous quantities of painkillers and antiseptics for the Union armies provided a great scope to expand production. By 1868, Pfizer’s revenues had doubled since the start of the war, and their product lines had expanded greatly.

After the war, Pfizer continued to focus on industrial chemicals as much as medicines, producing the citric acid needed for the emerging soft drinks industry, fuelling brands like Coca Cola and Dr Pepper’s expansion in the 1880s. This became their mainstay for many years, laying the basis for their continued growth. Also, when supply of tartaric acid was disrupted due to the civil war and increased tariffs, Pfizer developed its production to become the leading supplier of chemicals in the US.

“The ‘first industrial war’ involved drug producers as much as weapons manufacturers”

Erhart died in 1891, and Pfizer in 1906, leaving a company of around 200 employees in the hands of Emil Pfizer, who served as president until the 1940s, the last member of the Pfizer family to be involved in managing the company. Under his stewardship, Pfizer’s expertise in scientific production methods developed greatly. In 1919 their scientists pioneered mould fermentation production of citric acid from molasses, freeing their citric acid business from European citrus fruit supplies, which had been disrupted by the First World War. They developed a deep tank fermentation process, the principles of which would later be applied to the production of penicillin. As a consequence of Pfizer’s innovation, the price of citric acid tumbled over the succeeding decades, with the value of the chemical falling by 5/6ths in 20 years. In 1936 the company discovered a fermentation free method of producing vitamin C, which they rapidly expanded into vitamins B2 and B12 amongst others, rapidly becoming a leading vitamin producer – chemicals that were very novel at the time.

This expertise in fermentation and large-scale pharmaceutical production put Pfizer in good stead when in 1941 the US government appealed to the pharma industry for support in producing penicillin for the war effort. In an unprecedented collaboration, Pfizer worked with government scientists, the researchers such as Frederick Banting who had been working on the drug before the war, and a plethora of other players in the industry to markedly improve the efficiency of drug production, as they proudly state “most of the penicillin that [went] ashore with Allied force on D-Day [was] made by Pfizer”.

Antibiotics marked the transition to the modern Pfizer. Their follow-up to penicillin, Terramycin, first marketed in 1950, was both their first proprietary drug, and the first for which the company used sales reps, their soon to be formidable force of salesmen starting with just eight members.

Pfizer initiated its first major internationalisation at this stage, moving into nine new countries in 1951. It was at this time they set their site at Sandwich in the UK, initially just to finish processing compounds imported from America, but due to tariffs on imported products the company rapidly expanded the plant to accommodate producing medicines from scratch. Pfizer’s international expansion put great trust in their local staff compared to other organisations, recruiting nationals and giving them a great deal of autonomy.

“Lipitor…became the biggest-selling prescription medicine ever, earning Pfizer $12 billion a year in 2007, one quarter of its total sales”

The areas that Pfizer directed its research into expanded in these years as well. In 1952, it established its Agricultural Division, beginning its foray into animal health, and in 1953 acquired Roerig, a nutritional supplement specialist, which became incorporated as a division in its own right. By the 1960s, Pfizer were at their “most diversified point in [its] history” – in its own words, its interests “stretched from pills to perfume, and petrochemicals to pet products”.

Throughout the 60s and 70s the company continued to bring out new drugs, such as the broad spectrum antibiotic Vibramycin, and broadening its research base, reorganising its R&D operations in 1971 into a Central Research Division, and increasing spend on this area of the company from 5% to 15% of revenue. This attention to innovation began to pay off in the 1980s, with a series of blockbusters, the first of which, the COX inhibitor Feldene, arrived in 1980 rapidly becoming one of the biggest-selling anti-inflammatories in the world. Others rapidly followed, including Glucotrol, aimed at diabetics, and Procardia, an anti-hypertensive. The 1990s and 2000s would soon take this blockbuster-based success to new levels.

The statin Lipitor, approved in 1997 for Warner-Lambert before their merger with Pfizer, became the biggest-selling prescription medicine ever, earning Pfizer $12 billion a year in 2007, one quarter of its total sales. It almost hadn’t made it through clinical development, facing problems with ineffective chiral isomers and limited efficacy in animal testing, but showed such impact in human trials that it blew the competition away.

But Pfizer’s almost Hollywood-level blockbuster of the 1990s was the little blue pill of Viagrar. Formulated initially at the Sandwich site in the UK as an anti-hypertensive, it was found have “unexpected” side effects that made the company rapidly change the indication to erectile dysfunction. But despite the cultural ubiquity, Viagra has recently faced the inevitable threat from competition and generics, dropping from 92% of the ED market in 2000 to around 50% in 2007, with vigorous competition from drugs such as Cialis and Levitra.

“Pfizer is the 6th largest lobbier in Washington, and spent $25 million on lobbying during the passing of Obama’s healthcare reform legislation alone”

Ups and downs

Like most pharma companies of its size, Pfizer has faced its fair share of controversy as one of the most well-known drugmakers in the world.

In 2009, Pfizer faced more than $2 billion in legal settlement payments over marketing practices for drugs, and around the same time announced it would close a large number of manufacturing and R&D sites worldwide, including its Sandwich facility, which at the time employed 2,400 people (though it ended up maintaining a reduced presence at the site).

In the late 2000s/early 2010s, Pfizer, like many other big pharma companies, was experiencing pipeline difficulties too, with drugs accounting for 40% of its sales coming off patent, and a series of high-profile failures of drugs in development, such as the anti-cholesterol drug torcetrapib that caused a marked increase in deaths compared with the control group in clinical trials. The news of this disastrous result came days after CEO Jeff Kindler had hailed the drug as potentially “one of the most important compounds of our generation”. Likewise, tanezumab, an anti-osteoarthritic, failed in trials.

However, these challenges in the core mission of drug discovery led Pfizer to focus on other means of keeping up its dominant position. One thing that highlighted this changed focus was the appointment of Kindler as CEO in 2006. Kindler was trained as a lawyer, and was a relatively new employee when he was given the top job in preference to others of much longer standing with scientific experience, highlighting the increasing importance of legal and marketing issues over traditional R&D. He was succeeded by Ian Read and later Albert Bourla.

Perhaps unsurprisingly for the biggest company in one of the biggest industries in the world, Pfizer has also been proficient in exerting its considerable political influence to preserve its interests, coming in as the 6th largest lobbier in Washington, and spending $US 25 million on lobbying during the passing of Obama’s healthcare reform legislation alone. It has been key in pushing counterfeit drugs up the political agenda, in part due to its ownership of that most counterfeited of drugs, Viagra. It has also been highly critical of parallel trade, and has been one of those militating for a pharmaceutical repackaging ban in the EU.

Despite this political clout, the company also tried to belay its image as a pharma monster, like many others in the industry, by spending generously on charity, donating AIDS drugs both to poor communities in the US, and to developing countries.

The era of mega-mergers

Since the turn of the millennium, Pfizer has embarked on a series of mega-mergers, gobbling up Warner-Lambert in 2000, Pharmacia and Upjohn in 2002, Wyeth in 2009, and Medivation in 2016.

In 2015 the company also paid $17 billion to acquire Hospira, a firm specialising in injectable drugs and biosimilars, at a time when copycat biologics were starting to make real waves in the market. The deal seemed to be a precursor to Pfizer’s plans to separate its patent-protected medicines business from its off-patent portfolio.

These plans were soon abandoned and Hospira has remained a key part of the core Pfizer organisation – but that didn’t put the idea of separate business units to rest completely.

In 2017/2018 Pfizer attempted to sell its consumer health unit, but buyers including Proctor & Gamble and GSK pulled out of negotiations.

This caused Pfizer to change its tactics, and instead the company ended up signing a deal with GSK to combine the two companies’ consumer health businesses and form a joint venture with combined annual sales of $12.7 billion.

Pfizer and GSK plan to divest the business completely in the long term and reap the rewards, while merging the two businesses is also expected to create cost savings for both partners.

Similarly, in 2019 Pfizer announced a deal to merge its Upjohn generics business with Mylan, creating a combined company called Viatris. The $12 billion deal was cleared in November 2020, creating a generics behemoth with annual sales of around $19 to $20 billion and operations in 165 markets around the word.

This era, though, was also marked by two major failed acquisitions, which both courted controversy due to Pfizer’s intention to exploit tax loopholes.

In 2014 the company made an offer of around $100 billion to acquire UK firm AstraZeneca (which at the time was going through a rough patch).

AZ seemed to have little interest in the idea, and the deal was instantly controversial in both Europe and the US. The merger would have created the biggest pharmaceutical company in the world – and would have given Pfizer a way to avoid paying costly US taxes on foreign earnings (a stance that president Barack Obama criticised heavily).

Indeed, critics feared this redomiciling was the main aim of the merger, and that Pfizer wouldn’t sustain investment in UK R&D in the long term.

Unusually, the UK parliament ended up getting involved, perhaps underlining the importance of AZ to the country’s life sciences sector, with both AZ and Pfizer asked to argue for the future of the company in parliamentary hearings. Pfizer seemed unable to allay the concerns of prime minister David Cameron and business secretary Vince Cable.

After numerous “friendly bids” and just as many rejections, Pfizer eventually made a final offer of £69.3 billion ($118 billion) – which was also turned down by AZ, with the company saying it was “inadequate”.

Leif Johansson, AZ’s chairman, did not mince his words, saying: “Pfizer’s approach throughout its pursuit of AstraZeneca appears to have been fundamentally driven by the corporate financial benefits to its shareholders of cost savings and tax minimisation.

“From our first meeting in January to our latest discussion yesterday, and in the numerous phone calls in between, Pfizer has failed to make a compelling strategic, business or value case. The Board is firm in its conviction as to the appropriate terms to recommend to shareholders.”

This did not stymie Pfizer’s desire to move its HQ out of the US, though. The next year it also attempted a ‘reverse takeover’ of Irish Pharma firm Allergan – where, technically, Allergan would acquire the US company and rename itself as Pfizer, allowing Pfizer to have its tax base in Ireland.

At the time $160 billion deal was the biggest ever seen in the pharma sector.

But soon the Obama administration came down hard on such ‘tax inversion’ deals, changing laws such that the deal was no longer attractive to Pfizer.

No signs of slowing down

Despite some setbacks, Pfizer remains one of the biggest pharma companies in the world today. The sheer size of the organisation is mindboggling, totalling well over 100,000 employees. One commentator compared the company’s 38,000 sales reps to “three army divisions”, a sales team that has been immortalised in a Hollywood rom-com of all things – Love and Other Drugs, starring Jake Gyllenhaal and Anne Hathaway.

And with the company becoming one of the first in the world to get a COVID-19 vaccine approved – via its collaboration with  BioNTech – it feels like we’re only on the cusp of seeing where the company could head in the future.

Pfizer’s sheer diversity and economies of scale likely mean it will have the power to shape the pharmaceutical industry well into the 21st century. With fingers in every pie, ranging from small molecules to biologics in every clinical area, to stem cells and consumer goods, Pfizer will surely celebrate its 200th anniversary in as strong a position as it spent the last 160 years.

For all the latest Pfizer news follow pharmaphorum’s Pfizer tag.

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Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it.

As predicted by pharmaphorum, the regulator was able to move faster than its counterparts from the European Medicines Agency, who are also conducting a separate review of the data.

Pfizer and BioNTech have an agreement to supply the UK with 40 million doses of the vaccine, which is called BNT162b2 and was shown to be 95% effective in a phase 3 trial.

The companies said they will take immediate action to begin delivery of the vaccine and the first doses are expected to arrive in the country over the coming days, with the entire tranche expected to be complete next year.

Distribution will be prioritised – the Joint Committee on Vaccine and Immunisation has already set out priority groups who will receive the vaccine.

There are 11 groups, with older adults living in care homes and care home workers in the first group and those aged 80 years of age and older and health and social care workers second on the list

Delivery will begin throughout 2020 and 2021 to ensure fair allocation of the vaccines across different areas.

Another issue will be the logistical challenges of storing the RNA-based vaccine at around -70C and sending it out to clinics and GP surgeries across the country.

Danny Mortimer, chief executive of the NHS Confederation, which represents organisations across the healthcare sector, said there are still questions that need to be ironed out to support the delivery process.

Mortimer said: “This is the starting klaxon for people readying to deliver the vaccine. What’s ahead will be a marathon and not a sprint, with many months ahead to vaccinate everyone who needs it.

“This welcome news, however, does not mean that we are immediately out of the woods.

“Our already-stretched NHS faces a monumental effort now to roll-out the vaccine quickly and effectively.”

Nevertheless the UK health secretary Matt Hancock tweeted that “help is on its way” after the announcement.

Earlier this month the UK became the first country in Europe to pass 50,000 deaths from the coronavirus.

Transmission rates have fallen in the last month but only because of another economically crippling national lockdown, which has cost thousands of people their livelihoods as businesses struggled to survive.

Pfizer’s CEO Albert Bourla said: “As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”

The MHRA is not the first national regulator to approve a coronavirus vaccine – that accolade goes to the Russian regulator, which backed the “Sputnik V” vaccine developed independently by a team in Moscow.

But this is the first approval based on phase 3 data as the Russian vaccine was only licensed on an interim basis after a review of earlier clinical data.

Other regulators are also reviewing the Pfizer/BioNTech vaccine, including the FDA, and the MHRA is also reviewing data rivals from Moderna and AstraZeneca/Oxford University.

Feature image © BioNTech SE 2020, all rights reserved

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BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19

Shots:

  • The companies have submitted CMA to the EMA for BNT162b2, against COVID-19. The submission completes the rolling review process initiated on Oct 6, 2020
  • The submitted data showed a 95% efficacy rate, efficacy was consistent across age, gender, race, and ethnicity demographics, with an observed efficacy in adults aged ≥65yrs. of >94%, favorable tolerability with no safety concerns
  • In addition to submission to EMA, FDA & MHRA, the companies have also initiated additional rolling submissions across the globe including in Australia, Canada, and Japan, and plan to submit applications to other regulatory agencies globally

Click here ­to­ read full press release/ article | Ref: Globe Newswire | Image: Stat

The post BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19 first appeared on PharmaShots.

How does the Pfizer/BioNTech vaccine work and who will get it?

Covid vaccine with an efficacy of almost 95% has been authorised by the UK medicines regulator

The Pfizer/BioNTech Covid vaccine, which has an efficacy of almost 95%, has been authorised by the UK medicines regulator, making the UK the first western country to license a vaccine against the disease. The UK has 40m doses of this vaccine on order.

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Pfizer/BioNTech say COVID-19 vaccine could be approved in Europe by year-end

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year.

The filing for a conditional marketing authorisation completed the rolling submission process that began on October 6.

The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results.

If the EMA decided that the benefits of the vaccine candidate outweigh its risks in protecting against COVID-19, it will recommend a conditional marketing authorisation that could enable use of the vaccine in Europe by the end of 2020.

The data submitted show a vaccine efficacy rate of 95% in the companies’ phase 3 clinical study, which involved patients without previous infection with the SARS-CoV-2 infection and also people with and without previous infection.

Efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%, the companies said.

The first primary objective analysis was based on 170 confirmed cases of COVID-19. In the trial, BNT162b2 also showed an overall favourable tolerability with no safety concerns reported to date.

Approximately 42% of global participants and 30% of US participants in the phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age, the companies noted.

The FDA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have already begun their reviews and similar rolling submissions have begun in countries including Australia, Canada and Japan.

Despite the fast review, the company insisted that the potential vaccine will be assessed according to the EMA’s normal standards for quality and safety.

The EMA has also confirmed it has received a filing from Moderna, which is producing a rival vaccine based on similar RNA technology.

If approved these vaccines will break new ground as it will be the first time RNA vaccines have been used.

They work by using a short length of genetic code that makes the body produce the “Spike” protein seen on the surface of the SARS-CoV-2 coronavirus.

This encourages the body to produce antibodies that neutralise the virus in the event of an infection.

 

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UK appoints COVID-19 vaccine rollout minister as country preps for launch

The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine.

According to press reports, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) could become one of the first bodies to approve the vaccine.

According to the Financial Times, the MHRA could approve the vaccine by 7th December after the companies announced supportive data from a phase 3 trial mid-way through November.

Nadhim Zahawi

Zahawi will therefore face the difficult task of overseeing distribution arrangements for the shot, which must be stored at around -70c during transit to retain its integrity.

A minister for business and industry, Zahari will temporarily relinquish responsibility for most of his duties at the Department for Business, Energy and Industrial Strategy (BEIS).

The interim arrangement will see the MP for Stratford-on-Avon serve as a joint minister between the BEIS and the Department for Health and Social Care.

The vaccines can only be kept in a fridge for up to five days before being administered, although Pfizer has designed a “pizza box” style transportation container.

The UK has ordered 40 million doses of the two-shot product, which could be up to 95% effective in preventing diseases, according to the companies’ top-line data.

Although the European Medicines Agency technically has authority to authorise medicines for the UK until December 31 under Brexit transition arrangements, the MHRA can temporarily authorise products in cases of urgent need.

The government has also written to the MHRA, asking it to use the same process to authorise the rival vaccine from AstraZeneca and Oxford University.

As reported by pharmaphorum, the MHRA’s forthcoming spilt from the EMA could potentially allow it to be more agile in its decision-making after Brexit.

Emergency approval is also expected in the US next week, the FT added, with shipments starting across the country within 24 hours of the announcement.

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BioNTech’s Covid vaccine is a triumph of innovation and immigration | Hans-Werner Sinn

Pioneered by a Turkish-German couple, its significance exceeds its practical value

The world took note when the German startup BioNTech announced its breakthrough in the development of a new type of vaccine to combat Covid-19. After testing tens of thousands of people, BioNTech’s vaccine has been shown to be 95% effective in providing protection for those who would otherwise have been infected. The company was the first to apply for emergency use authorisation for a coronavirus vaccine in the US and it has announced it will soon take similar steps in Europe.

Antiviral vaccines are usually made with devitalised viral materials fabricated outside the body but BioNTech has pursued a new method of injecting genetically modified RNA into the patient. This prompts the patient’s cells to produce a characteristic protein of the relevant Sars-CoV-2 virus themselves, enabling the body’s immune system to build up an effective response before it encounters the real virus.

Related: Uğur Şahin and Özlem Türeci: German ‘dream team’ behind vaccine

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Concerns emerge after AZ’s lucky vaccine trial ‘mistake’

AstraZeneca may have tried a positive spin on the trial mistake that led to the accidental discovery of the low dose COVID-19 vaccine regime with the highest efficacy– but the revelation has drawn a mixed response from commentators.

The company’s share price has tumbled since the announcement of the trial results from AZD-1222 at the beginning of the week, reflecting an overall loss of confidence in the company’s handling of the trial.

This was also reflected in numerous press reports that called into question the strength of the findings, particularly in the smaller group of patients who were given the lower dose.

As pointed out by the New York Times, there were fewer than 2,800 volunteers who got the more effective dose, which was accidentally given at half strength followed by a full strength dose 28 days later.

There were more than 23,000 participants in the data from the UK and Brazil, and the numbers used to calculate efficacy are lower than those used by rivals such as Moderna and Pfizer/BioNtech to calculate efficacy.

Pfizer tested its vaccine on more than 43,000 people and Moderna based its findings on more than 30,000 patients.

And then there’s the question of the deviation from the trial protocol that AZ’s research chief Mene Pangalos admitted to earlier this week.

After realising several thousand volunteers had accidentally received the wrong dose, Oxford University academics running the trial decided to press on regardless with the weaker dosing regime, breaking with the predetermined design.

As pointed out by Canada’s CBC, the change was okayed by regulators but nevertheless the stronger effect could still be a statistical quirk.

There was another confounding factor in that none of the people in the low-dose group were more than 55 years old.

Younger people would tend to produce a stronger immune response than older people, which could account for the differing results.

The decision to pool results and give a composite figure from the two dose strengths is another factor that is causing concern.

Moncef Slaoui, who leads the US COVID-19 vaccine programme Operation Warp Speed has told reports that his team are trying to determine what immune response the vaccine produced.

A separate study being conducted in the US may be modified to include the half-dose followed by a full strength booster, said Slaoui, who used to be GlaxoSmithKline’s vaccines chief.

Many reports point out that AZ’s shot has an advantage in that it can be stored in fridges instead of at the ultra-cool temperatures required by those from Moderna and Pfizer.

But trial results from these mRNA-based rivals seem to be much cleaner and could pave the way to faster decisions from regulators, which could be due in the next few days.

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A vaccine revolution | podcast

Results from clinical trials have shown that the world has three apparently highly effective vaccines for Covid-19. With the race now on for regulatory approval, production and distribution, is the end of the pandemic within reach?

After a gruelling year of successive waves of Covid-19 infections and national lockdowns there has been a burst of good news this month, with three separate vaccine candidates performing extremely well in clinical trials.

First, Pfizer and Moderna announced that their vaccines were testing at an efficacy of around 95%. Then came the news that the AstraZeneca vaccine (the one pre-ordered in bulk by the UK government) was hitting 90%. It marks not just a new phase in the Covid-19 pandemic but potentially a revolution in vaccine technology itself.

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AstraZeneca, Oxford are latest to unveil Covid-10 vaccine results

The partners pooled results from two trials and two different dosing regimens, one appearing to be more effective than the other. They hope to produce 3 billion doses in 2021 with an emphasis on serving poorer countries.

AZ preps filings for COVID-19 jab, UK nears decision on Pfizer rival

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective.

AZ made the announcement as the UK regulator reportedly gears up to make a decision on the rival vaccine from Pfizer and BioNTech, ahead of counterparts in the US and Europe.

Results from trials conducted in the UK and Brazil showed an efficacy of 90% in 2,741 patients receiving the vaccine as a half dose, followed by a full dose at least one month apart.

Another regimen of the vaccine codenamed AZD1222, given to 8,895 patients showed 62% efficacy when given as two full doses at least one month apart.

The combined analysis shows efficacy of 70% and the company said there were no serious safety events confirmed as related to the vaccine.

AZ said the trial has therefore met its main efficacy goal and will immediately prepare filings to regulators around the world to allow early approval.

It will also seek an Emergency Use Listing from the World Health Organization to make the shot quickly available in low income countries.

AZ made no further reference to the safety scare that caused trials of the vaccine to be halted for several weeks in September.

The AZ vaccine also has a considerable convenience advantage over RNA-based vaccines from Pfizer and Moderna.

The AZ shot can be stored at refrigerator temperatures making distribution much easier, while the vaccines from Pfizer and Moderna require ultra-cool temperatures to prevent their active ingredients from breaking down.

AZD-1222 is based on a weakened cold virus that causes the disease in chimpanzees, which has been modified so that it causes the body to code for the “spike” protein seen on the surface of the SARS-CoV-2 coronavirus that causes COVID-19.

The body produces antibodies against the protein, which neutralise the coronavirus in the event of an infection.

AZ announced the news as reports suggested the UK could approve Pfizer’s rival by the end of the week.

Citing a gated report from the Daily Telegraph, Reuters said the Medicines and Healthcare Products Regulatory Agency could have concluded its review of the shot developed by Pfizer and BioNTech by the end of the week.

This would allow distribution of the vaccine to begin during the first week in December.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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The Guardian view on coronavirus and vaccine scepticism: time to act | Editorial

Plans for mass immunisation against Covid-19 are developing fast, but concerns must be addressed

In the 1960s, academics studying rumours drew inspiration from epidemiology. They noted how such stories spread through communities, “infecting” some individuals while others seemed immune, and how more resistant populations could stop their spread.

Their insights have in turn been taken up by health professionals. Hearsay can be useful, helping to catch disease outbreaks. It can also be deadly. Though vaccine hesitancy is as old as vaccines themselves, it has risen sharply in many countries in recent years. Unfounded scare stories about the safety of immunisation programmes have contributed to growing scepticism and outright refusal, with fatal consequences. In her new book Stuck: How Vaccine Rumours Start – and Why They Don’t Go Away, Prof Heidi Larson notes the paradox: we have better vaccine science, more safety regulations and processes than ever before, yet a doubting public.

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First Americans may get Covid vaccine in December if US approves Pfizer request

Pharmaceutical partners submitted bid to the FDA for vaccine to be reviewed and emergency authorization may occur within weeks

It could take as little as three weeks for US regulators to approve Pfizer and partner BioNTech’s emergency authorization request for their Covid-19 vaccine – with the first Americans being offered the first inoculation outside clinical trials in early December.

The major turning point in the worsening coronavirus pandemic came on Friday morning when the pharmaceutical partners submitted their bid to the Food and Drug Administration (FDA) for their vaccine to be reviewed.

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PharmaShots Weekly Snapshot (Nov 16-20, 2020)

Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19

Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir

Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, Develop, Manufacture, Mesoblast, Novartis, Remestemcel-L, Signs, Treatment

Alvotech Reports the US FDA and EMA’s Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab)

Published: Nov 20,2020 | Tags: (adalimumab), Alvotech, AVT-301 Study, AVT-GL-101, AVT02, Chronic Plaque Psoriasis, EMA, Humira, Proposed Biosimilar, Regulatory Applications, Submits, Us FDA

Lilly Signs Agreement with Ypsomed to Advance an Automated Insulin Delivery System for People with Diabetes

Published: Nov 20, 2020 | Tags: Lilly, Signs, Agreement, Ypsomed, Advance, Automated Insulin Delivery System, People, Diabetes

Pfizer And LianBio Collaborate to Expand the Development of Novel Therapeutics in Greater China

Published: Nov 20, 2020 | Tags: Pfizer, LianBio, Collaborate, Expand, Development, Novel Therapeutics, Greater China

AstraZenca’s Imfinzi (durvalumab) Receives the US FDA’s Approval for Less-Frequent Fixed-Dose Use

Published: Nov 20,2020 | Tags: AstraZenca, CASPIAN Study, durvalumab, Imfinzi, P-lll, PACIFIC, US FDA’s

Chiesi’s Bronchitol (mannitol) Inhalation Powder Receives the US FDA’s Approval for Cystic Fibrosis

Published: Nov 19, 2020 | Tags: approval, Bronchitol, Chiesi, Cystic Fibrosis, Inhalation, Mannitol, Powder, Pulmonary, receives, US FDA

Lucira’s All-In-One Test Kit Receives the US FDA’s EUA as the First COVID-19 Test for Self-Testing at Home

Published: Nov 19, 2020 | Tags: Authorization, COVID-19, First, Home, Lucira, Lucira Health, Molecular, Prescription, receives, Test, Us FDA

Bayer to Fund Five New Startup Companies as Part of G4A Digital Health Partnerships Program

Published: Nov 19, 2020 | Tags: Bayer, Collaborate, Developed, G4A Digital Health, Healthcare Solutions, Integrated

ViiV’s PROgress Study Demonstrates Inclusion of PROs into Clinical Practice Can Improve HIV Care

Published: Nov 19, 2020 | Tags: Progress, reports, results, study, ViiV Healthcare

Pear Therapeutics Launches Somryst Insomnia App Via an End-to-End Virtual Care Experience

Published: Nov 19, 2020 | Tags: Chronic Insomnia, Launches, Pear Therapeutics, Somryst

Pfizer and BioNTech’s BNT162b2 Demonstrates 95% Efficacy in Preventing COVID-19

Published: Nov 19, 2020 | Tags: 95%, BioNTech, BNT162b2, COVID-19, Demonstrates, Efficacy, Pfizer, Preventing

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza

Published: Nov 19, 2020 | Tags: EC’s, Influenza, Marketing Authorization, patients, quadrivalent recombinant influenza vaccine, receives, Sanofi, Supemtek

Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders

Published: Nov 18,2020 | Tags: Acceptance, Biogen, Biosimilar, FDA Filing, Lucentis, ranibizumab, Retinal Vascular Disorders, Samsung Bioepis, SB11

BioMarin Pharmaceutical Signs an Agreement with Deep Genomics on Advancing Programs Identified Using Artificial Intelligence

Published: Nov 18, 2020 | Tags: Advancing, Agreement, Artificial Intelligence, BioMarin Pharmaceutical, Deep Genomics, Identified, Programs, Signs, Using

Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2

Published: Nov 18, 2020 | Tags: 4, COVID-19, Delivery, Deployment, Immunization, Pfizer, Pilot, Program, states, Updates, US,

Sanofi’s Avalglucosidase alfa Receives US FDA’s Priority Review as Enzyme Replacement Therapy for Pompe Disease

Published: Nov 18, 2020 | Tags: Avalglucosidase-alfa, BLA, Enzyme Replacement Therapy, Pompe disease, Priority Review, receives, Sanofi, US, FDA

ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

Published: Nov 18,2020 | Tags: Breakthrough, Cabotegravir, Designation, HIV, receives, therapy, Us FDA, ViiV Healthcare

Bayer’s Finerenone Demonstrates Positive Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes

Published: Nov 18,2020 | Tags: BAY 94-8862, Bayer, Cardiovascular Disease, Chronic Kidney Disease, FIDELIO-DKD Study, Finerenone, Inflammatory, Type 2 Diabetes

QBiotics’ Stelfonta (tigilanol tiglate) Receives the US FDA’s Approval as the First Treatment for Non-Metastatic MCT in Dogs

Published: Nov 17, 2020 | Tags: (tigilanol tiglate injection), Non-Metastatic Mast Cell Tumors, QBiotics Group, receives, Stelfonta, US FDA’s Approval

Johnson & Johnson Initiates Second Global P-III Study of its COVID-19 Vaccine

Published: Nov 17, 2020 | Tags: COVID-19, ENSEMBLE, ENSEMBLE-2 Study, Initiates, Johnson & Johnson, P-lll

Roche Signs a License Agreement with Lead Pharma to Develop Oral Therapies for Immune-Mediated Diseases

Published: Nov 17,2020 | Tags: Develop, Immune Mediated Diseases, Lead Pharma, License Agreement, Research Collaboration, Roche, Signs, Small Oral Molecules

Zymeworks and ALX Oncology Collaborate to Evaluate Zanidatamab + ALX148 for Advanced HER2‑Expressing Breast Cancer

Published: Nov 17,2020 | Tags: Advanced, ALX Oncology, ALX148, Breast Cancer, Collaborate, Evaluate, HER2‑Expressing, Zanidatamab, Zymeworks

Moderna’s mRNA-1273 Demonstrates 94.5% Efficacy in Preventing Symptomatic COVID-19

Published: Nov 17, 2020 | Tags: COVE Study, COVID-19, Interim Analysis, Moderna, mRNA-1273, P-lll, reports, results

Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19

Published: Nov 17,2020 | Tags: Against, Bharat Biotech, Covaxin, COVID-19, Initiates, P-III, study

Microsoft Collaborates with Twist and Illumina to Advance Data Storage in DNA

Published: Nov 16, 2020 | Tags: advance, Collaborates, Data Storage, DNA, Illumina, Microsoft, Twist

J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development

Published: Nov 16, 2020 | Tags: Agreement, Candidate, Covid-19 Vaccine, Development, Expand, J&J, U.S. Department of Health & Human Services

Eisai’s Fycompa (perampanel) Receives EC’s Approval for Expanded Indication in Pediatric Patients with POS and PGTCS

Published: Nov 16, 2020 | Tags: Eisai’s, EU’s Approval, Fycompa, perampanel, PGTCS, POS, receives

Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to Treat Influenza

Published: Nov 16, 2020 | Tags: baloxavir marboxil, EU’s Approval, Influenza, receives, Roche, Xofluza

Eli Lilly Signs a License Agreement with Seed Therapeutics for Protein Degradation-Based Therapies

Published: Nov 16, 2020 | Tags: Eli Lilly, License Agreement, Protein Degradation-Based Therapies, Seed Therapeutics, Signs

Henlius Report the NMPA’s Acceptance of HLX15 (biosimilar, Daratumumab) to Treat Multiple Myeloma

Published: Nov 16, 2020 | Tags: (biosimilar, Acceptance, daratumumab, Henlius, HLX15, Multiple Myeloma, NMPA, Report, Treat

Related Post: PharmaShots Weekly Snapshots (Nov 09-13, 2020)

The post PharmaShots Weekly Snapshot (Nov 16-20, 2020) first appeared on PharmaShots.

Pfizer/BioNTech prep US COVID-19 vaccine launch after emergency filing

Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end.

The announcement is no surprise as earlier this week, Pfizer’s CEO Albert Bourla said the company was preparing to file phase 3 data from the vaccine known as BNT162b2 with the FDA after gathering the required amount of safety data.

On the efficacy side, the filing will highlight a vaccine efficacy rate of 95% in a phase 3 study testing patients with and without previous infection with SARS-CoV-2.

There was also solicited safety data from a random subset of around 8,000 patients aged 18 or above and unsolicited safety data from around 38,000 trial participants.

Pfizer said the companies are ready to distribute the vaccine candidate “within hours” after authorisation, which should occur within the next month or so.

The FDA this week authorised Eli Lilly’s baricitinib, just over a month after the company announced supportive phase 3 data in COVID-19.

While the regulator has not given guidance on how long the review will take, expect a similar, if not quicker, timeline given the importance of a working vaccine in the effort against the pandemic.

The companies have already begun rolling submissions across the globe including in Australia, Canada, Chile, Europe, Japan and the UK, and plan to submit applications immediately to other regulatory agencies around the world.

Based on current projections the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

Pfizer and BioNTech are also working with governments and health ministries around the world to set up delivery arrangements for the vaccine, which must be stored at around -70C to maintain its integrity.

According to reports Pfizer has already designed “pizza box” storage cases for the vaccine to help with this and will likely distribute them from several hubs in each country.

The companies said they had already built up expertise after delivering the vaccine to more than 150 clinical trial sites across the US, as well as Europe, Latin America, and South Africa.

The phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate or placebo as of 13 November, 2020.

It is one of 11 vaccines that are in phase 3 development, including contenders from Moderna, Novavax and AstraZeneca, according to the World Health Organization’s regularly updated tracker document.

Feature image courtesy of NIAID/Rocky Mountain Laboratories

The post Pfizer/BioNTech prep US COVID-19 vaccine launch after emergency filing appeared first on .

Pfizer and BioNTech’s BNT162b2 Demonstrates 95% Efficacy in Preventing COVID-19

Shots:

  • The primary efficacy analysis demonstrated that BNT162b2 is 95% effective against COVID-19 beginning 28 days after the first dose. The study evaluated 170 confirmed cases of COVID-19 with 162 in PBO group vs 8 in the vaccine group
  • The observed efficacy in adults over 65yrs. of age was ~94% and was well tolerated across all populations with ~43,000 participants, no serious safety concerns were observed
  • The companies plan to submit the data within days to the FDA for EUA and share data with other regulatory agencies across the globe and expect to produce globally ~50M vaccine doses in 2020 and ~1.3B doses by the end of 2021

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Pfizer

The post Pfizer and BioNTech’s BNT162b2 Demonstrates 95% Efficacy in Preventing COVID-19 first appeared on PharmaShots.

Pfizer Covid-19 vaccine has 95% efficacy and is safe, further analysis shows

Among first 170 Covid cases in trial, eight had received vaccine and 162 were in placebo group

The Pfizer/BioNTech vaccine against Covid-19 performs even better than previously thought, with 95% efficacy, equalling the early results from Moderna on Monday, according to an analysis of the final data from their trials, which paves the way for regulators to grant an emergency licence and vaccination campaigns to begin.

The news will excite scientists, public health experts and politicians. Pfizer/BioNTech say they also have the necessary safety data that regulatory bodies require, and will submit the vaccine for emergency approval within days to the US Food and Drug Administration and other regulators around the world.

Continue reading…

Standing ovation: Spike Lee to direct musical about Viagra

The director’s next project after Da 5 Bloods is based on a 2018 Esquire article and will be co-written by Kwame Kwei-Armah

Spike Lee is to direct a musical about the impotence medication Viagra, it has been revealed.

According to Deadline, the film will be Lee’s next project after Da 5 Bloods and American Utopia, and is based on a 2018 Esquire article headlined All Rise, which chronicled the discovery and marketing of the drug (called sildenafil citrate). Lee is co-writing the script with British playwright Kwame Kwei-Armah, current artistic director of the Young Vic, and the music is by songwriters Stew Stewart and Heidi Rodewald (who previously collaborated on the stage musical Passing Strange, filmed by Lee in 2008).

First And Foremost, I Thank Ms. Jacquelyn Shelton Lee. I Thank My Late Mother For As She Would Say Taking “My Narrow, Rusty Behind” Dragging, Kickin’ And Screamin’ To The Movies When I Wuz A Nappy Headed Kid Growing Up In Da Streets Of Da People’s Republic Of Brooklyn. I Did Not Want To See Corny People Singin’ And Dancin’. I Instead Wanted To Play With My Friends On Da Block, Stoop Ball, Stick Ball, Punch Ball, Soft Ball, Basketball, 2 Hand Touch, Tackle Football, Coco Leevio, Johnny On Da Pony, Hot Peas And Butter, Crack Top, Down Da Sewer And Of Course-Booty’s Up. All The Great New York City Street Games That Might Be Sadly Lost Forever. My Father, Bill Lee, Jazz/Folk Bassist, Composer HATED HollyWeird Movies, Henceforth And What Not, Me Being The Eldest Of 5 Children I Became Mommy’s Movie Date. She Was A Cinefile. Thank You Lawdy She Didn’t Listen To My Ongoing Complaints About Musicals. So Finally Going Into My 4th Decade As A Filmmaker I Will Be Directing A DANCIN’, ALL SINGIN’ MUSICAL Spike Lee Joint And I Can’t Wait. My Moms Has Been Waiting TOO!!! And Dats Da Rodgers And Hammerstein Truth, Ruth.

Continue reading…

Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2

Shots:

  • Pfizer launched a pilot program to support the state’s planning, deployment & administration of the COVID-19 vaccine candidate, to build on coordination with the relevant US agencies
  • Pfizer has been working with US officials in OWS & the US CDC to help ensure that after potential authorization or approval, the Pfizer-bioNtech COVID-19 vaccine can reach those in most need as quickly and equitably as possible
  • The BNT162b2 COVID-19 vaccine is not currently approved for distribution anywhere in the world, both collaborators are committed to developing these novel vaccines with preclinical & clinical data at the forefront of all their decision making

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: Pfizer

The post Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2 first appeared on PharmaShots.

Pfizer prepares to file COVID-19 shot after reaching safety milestone

Pfizer is preparing to file its COVID-19 vaccine after a trial reached the safety milestone required by US regulators for emergency use, according to press reports.

The company’s CEO Albert Bourla said that the company is preparing to submit its data to the FDA following last week’s announcement that the vaccine is more than 90% effective, according to an interim analysis of a phase 3 trial.

Bourla was speaking at a virtual conference hosted by the New York Times, without saying when the company expected to file for the Emergency Use Authorization with the FDA.

“We are preparing now for submissions,” said Bourla.

However the company has already said it would have the two months of safety data required by the FDA by the third week of November.

But according to Bloomberg he conceded that there are important questions about the vaccine that remain to be answered, such as how long it remains effective.

“When it comes to how durable the protection could be, this is something we don’t know yet,” he said.

More efficacy results are due soon, he said.

Developed in partnership with Germany’s BioNTech, Pfizer’s vaccine is slightly ahead of a rival from Moderna in development.

Both vaccines are based on mRNA technology but Moderna’s rival seems to be slightly more effective with an efficacy of 94.5%.

Moderna’s shot is also easier to handle, requiring storage at -20C instead of the much more challenging -70C for the Pfizer vaccine.

There are also issues with access to an already available therapy for COVID-19, Eli Lilly’s antibody therapy bamlanivimab, according to reports.

Reuters reported that hospitals in the US are rationing use of the drug because demand is outstripping supply following an EUA from the FDA last week.

The federal government has paid $1,250 per dose for 300,000 doses of bamlanivimab, enough to last for a week at current infections levels, according to Reuters.

The post Pfizer prepares to file COVID-19 shot after reaching safety milestone appeared first on .

Pfizer begins US pilot delivery programme for COVID-19 vaccine

Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by its ultra-cold storage requirements.

The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials.

But it has a major drawback in that it must be shipped and stored at around -70C, unlike conventional vaccines that are stored at standard refrigerator temperatures.

The company has picked four US states – Rhode Island, Texas, New Mexico and Tennessee, to trial a delivery programme that aims to overcome this challenge.

Pfizer told Reuters in a statement: “We are hopeful that results from this vaccine delivery pilot will serve as the model for other US states and international governments, as they prepare to implement effective COVID-19 vaccine programmes.”

The four states will not receive the vaccine earlier because of the pilot, according to Pfizer.

Pfizer is poised to file the vaccine with the FDA in the coming days, seeking an Emergency Use Authorization (EUA) after gathering enough safety data required by the regulator.

It was the first company to announce top-line phase 3 results showing that its vaccine is effective last week.

Pfizer and BioNTech have a $1.95 billion deal to supply 100 million doses of the vaccine to the US government, which has an option to acquire up to 500 million additional doses.

There are 11 potential COVID vaccines in late-stage clinical development and since Pfizer’s announcement two more groups from Russia’s Gamaleya Research Institute and US biotech Moderna have published favourable efficacy results.

Both Pfizer and Moderna vaccines use synthetic messenger RNA to activate the immune system against the virus.

They both code for the “Spike” protein seen on the surface of the SARS-CoV-2 coronavirus, which causes the body to produce antibodies that neutralise the virus in the event of an infection.

Feature image courtesy of Rocky Mountain Laboratories/NIH

The post Pfizer begins US pilot delivery programme for COVID-19 vaccine appeared first on .

Easier distribution may make Moderna’s vaccine much more valuable | Nils Pratley

While Pfizer/BioNTech’s version requires -75C storage, Moderna’s could be easier to roll out

A second coronavirus vaccine candidate was always likely to struggle to match the excitement of the first, at least in stock market terms. Sure enough, Moderna’s promising trial results merely added to the generally bullish mood in markets without generating the same sense of wild relief, and 5% rise in the FTSE 100 index, that Pfizer and BioNTech achieved a week ago.

But, actually, the key difference with Moderna’s version looks significant. It’s the fact the company says its vaccine can be transported and stored for up to six months at -20C and will then remain stable for 30 days at fridge temperatures. By contrast, Pfizer and BioNTech spoke about -75C in storage and then only five days of stability in conventional fridges.

Continue reading…

Moderna vaccine’s effectiveness bodes well for Oxford/AstraZeneca jab

Phase 3 success rate of 95% for US firm’s treatment is promising for UK vaccine trial

Hopes are rising for the Covid jab being developed by Oxford University, after Moderna became the second company to reveal impressive results from its vaccine trials.

Interim results from phase 3 clinical trials of the Covid vaccine from US company Moderna has revealed it to be almost 95% effective at preventing the disease. The news followed an announcement last week from Germany-based Pfizer and BioNTech that their vaccine was more than 90% effective.

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It’s the ‘vaccine hesitant’, not anti-vaxxers, who are troubling public health experts | Gaby Hinsliff

To make vaccination work, we must reach out to the naturally cautious – a bigger proportion than you might assume

Lydia Guthrie is not very daring by nature. A psychotherapist and mother of two from Oxford, she couldn’t be persuaded into bungee jumping for all the money in the world, and even shudders at skiing. “I’m very risk averse and a bit of a coward. I can’t even watch horror films.” Yet nonetheless, earlier this year she volunteered to be injected with an experimental Covid-19 vaccine as part of a clinical trial in the city, a partnership between the university, the NHS and drug company AstraZeneca.

Like all the guinea pigs, she doesn’t yet know if she got the real thing or the meningitis vaccine used as a dummy. She had a headache afterwards and felt exhausted for a couple of days, but has never regretted taking part. She trusts the university’s ethics panel, having encountered it through her own degree research, and was also swayed by gratitude towards the city’s John Radcliffe hospital, where she had her own children. “If it hadn’t been for the NHS we might all have died. I feel I owe them.”

Continue reading…

BioNTech vaccine scientist says jab could halve Covid transmission

Uğur Şahin ‘very confident’ vaccine candidate developed with Pfizer will cause big reduction in cases

The scientist behind the first potential Covid-19 vaccine to clear interim clinical trials says he is “very confident” the jab will reduce transmission of the disease, perhaps by 50%, resulting in a “dramatic” reduction in cases.

The German company BioNTech and the American pharmaceutical firm Pfizer announced to worldwide acclaim last week that their jointly developed vaccine candidate had proved 90% effective in stopping people from falling ill.

The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

Continue reading…

Vaccination hesitancy is about lack of trust. Compulsion is not the answer | Kenan Malik

Better to build social solidarity than to dismiss reluctance to be immunised as ignorance

“If a strain as deadly as the 1918 influenza emerges and people’s hesitancy to get vaccinated remains at the level it is today, a debilitating and fatal disease will spread.” So wrote Heidi Larson in 2018. Larson is director of the London-based Vaccine Confidence Project and probably the most knowledgeable person on the question of “vaccine hesitancy” – the unwillingness of some to get vaccinated.

Two years after Larson wrote those words, we do have a pandemic that so far has taken more than a million lives, including at least 50,000 in the UK. We also have the possibility of a vaccine, the first of a number that could transform the Covid-19 landscape. Whether they do depends not just on how effective they are, but also on the willingness of people to be vaccinated. In the US, just half the population seems so inclined. In Britain, the figure is higher – about 70% – but still probably insufficient to generate herd immunity.

The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

Continue reading…

PharmaShots Weekly Snapshots (Nov 09-13, 2020)

Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US

Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US

GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine

BD Acquires the Medical Business Assets of CUBEX

Published: Nov 13, 2020 | Tags: BD, Acquires, Medical Business, Assets, CUBEX

Health2Sync Divulges Benefits of Integrating Fitbit Wearable Devices into Diabetes Care in Taiwan

Published: Nov 13,2020 | Tags: Health2Sync, Divulges, Benefits, Integrating, Fitbit, Wearable Devices, Diabetes, Care, Taiwan

UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

 Published: Nov 13,2020 | Tags: UCB, Acquires, Handl Therapeutics, Augment, Gene Therapy,  Portfolio

Medtronic Launches InPen Integrated with CGM Data for People with Diabetes on MDI

Published: Nov 13,2020 | Tags: CGM Data, Diabetes, InPen, Integrated, Launches, MDI, Medtronic

Qiagen Collaborate with TScan to Develop T Cell-Based COVID-19 Test

Published: Nov 12,2020 | Tags: COVID-19, Exclusive, License Agreement, Option, Qiagen, Research, Signs, TScan Therapeutics

AstraZenca’s Calquence (acalabrutinib) Fails to Meet its Primary Endpoint in P-II Studies for COVID-19

Published: Nov 12,2020 | Tags: acalabrutinib, AstraZenca, CALAVI, Calquence, COVID-19, P-ll Study, Report, Respiratory Complications, results

Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19

Published: Nov 12,2020 | Tags: Agreement, BioNTech, BNT162b2, EU, European Commission, m-RNA Vaccine, Pfizer, Signs, Supply

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Published: Nov 12,2020 | Tags: Abrocitinib, JADE REGIMEN Study, moderate to severe Atopic Dermatitis (AD), P-lll, Pfizer, Positive, Report, results

Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC

Published: Nov 12,2020 | Tags: HNSCC, Interim, Moderna, mRNA-4157, P-l study, pembrolizumab, Report, results, SITC 2020

J&J Resumes all Clinical Trial of its COVID-19 Vaccine in the EU

Published: Nov 12,2020 | Tags: Clinical Trial, COVID-19, EU, J&J, Resumes, vaccine

CureVac Publishes Results of CVnCoV in Interim P-l Study for COVID-19

Published: Nov 11,2020 | Tags: COVID-19, CureVac, CVnCoV, Interim, P-l study, reports, results

Prestige Signs an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Published: Nov 11,2020 | Tags: Agreement, Biosimilar, Commercialize, Israel, Prestige, Signs, Teva, trastuzumab, Tuznue

NightWare Receives the US FDA’s Approval for the First Medical Device to Stop NightMAres Related to PTSD

Published: Nov 11,2020 | Tags: Designed, Marketing, New Device, Nightmare Disorder, Permit, PTSD, Reduce, Sleep, US FDA

Samsung Bioepis Initiates P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Nov 11,2020 | Tags: (Denosumab), Initiates, P-I study, Prolia, Proposed Biosimilar, Samsung Bioepis, SB16

Abbott Launches IonicRF Generator for Patients with Chronic Pain in the US

Published: Nov 11,2020 | Tags: Abbott, Chronic, Generator, IonicRF, Launch, Pain, patients, US, Use

Henlius Reports First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

Published: Nov 11,2020 | Tags: Henlius, Reports, First, Patient Dosing, P-l Study, HLX14, denosumab, biosimilar

Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373 to Treat COVID-19

Published: Nov 10, 2020 | Tags: COVID-19, Fast Track Designation, Novavax, NVX-CoV2373, receives, Treat, US FDA

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Published: Nov 10,2020 | Tags: Amgen, Asthma, AstraZeneca, NAVIGATOR, P-III, patients, Positive, reports, results, Severe, Tezepelumab, Trial, Uncontrolled

Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19

Published: Nov 10,2020 | Tags: Bamlanivimab, COVID-19, Diagnosed, EUA, Lilly, LY-CoV555, receives, recently, Treatment, Us FDA

Pfizer and BioNTech’s BNT16`2b2 Demonstrates 90% Efficacy in Preventing COVID-19

Published: Nov 10,2020 | Tags: Against, BioNTech, BNT162b2, Clinical, Pfizer, reports, study

AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia

Published: Nov 10,2020 | Tags: (acalabrutinib), AstraZeneca’s, Calquence, Chronic Lymphocytic Leukaemia (CLL), EU’s Approval, receives

Bayer Reports Regulatory Submission of Finerenone (BAY 94-8862) to the US and EU for CKD and T2D

Published: Nov 10,2020 | Tags: (BAY 94-8862), Bayer, EMA, Finerenone, Regulatory Applications, Submits, Treat Chronic Kidney Disease (CKD), Type 2 Diabetes (T2D), Us FDA

Alvotech and Cipla Collaborate to Ensure Access to Biosimilars in South Africa

Published: Nov 9,2020 | Tags: Access, Alvotech, Biosimilars, Cipla, Ensure, Exclusive Partnership, Expand, South Africa

Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

Published: Nov 9,2020 | Tags: (canakinumab), CAN-COVID Trial, Covid-19, Pneumonia, Cytokine Release Syndrome (CRS), Ilaris, Novartis, P-lll, Report, results

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma

Published: Nov 9,2020 | Tags: 2020, 218, Advanced, Renal, Cell, Carcinoma, Eisai, Everolimus, IKCS, lenvatinib, Lenvima, P-II, Presents, results, study

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Published: Nov 9, 2020 | Tags: 2020, Celltrion, Clinical, Conference, CT-P59, Fall, Korean Society of Infectious Diseases, P-I, Presents, results, Trial

The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

Published: Nov 9, 2020 | Tags: aducanumab, Advisory, Biogen, Committee, EMERGE, ENGAGE, Meeting, P-III, reports, study, Updates, Us FDA

Merck and Transcenta Collaborate to Implement Continuous Manufacturing for Protein Therapeutics

Published: Nov 9, 2020 | Tags: Collaborate, Continuous Manufacturing, Implement, Merck, Protein Therapeutics, Transcenta

Related Post: PharmaShots Weekly Snapshot (Nov 02-06, 2020)

The post PharmaShots Weekly Snapshots (Nov 09-13, 2020) first appeared on PharmaShots.

BioNTech chief rejects Trump claim it delayed Covid vaccine news

Exclusive: Ugur Şahin says he and Pfizer CEO received results night before announcement

The scientist behind the BioNTech/Pfizer coronavirus vaccine has defended his company from Donald Trump’s accusation that it deliberately delayed news of its rapid progress until after the election, saying “we don’t play politics”.

BioNTech, a German company, and the US pharmaceutical giant Pfizer announced on Monday that their jointly developed vaccine candidate had exceeded expectations in the crucial phase 3 vaccine trials, proving 90% effective in protecting people from coronavirus infections.

The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

Continue reading…

Scientist behind BioNTech/Pfizer vaccine says it can end pandemic

Exclusive: BioNTech’s CEO Uğur Şahin says he is confident vaccine can ‘bash the virus over the head’

The scientist behind the first Covid-19 vaccine to clear interim clinical trials says he is confident his product can “bash the virus over the head” and put an end to the pandemic that has held the world hostage in 2020.

The German company BioNTech and the US pharmaceutical giant Pfizer announced via a press release on Monday that their jointly developed vaccine candidate had outperformed expectations in the crucial phase 3 trials, proving 90% effective in stopping people from falling ill.

Related: 6 key questions about the Pfizer/BioNTech Covid-19 vaccine

Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

Continue reading…

The Covid vaccine will benefit humanity – we should all own the patent | Owen Jones

The pharmaceutical industry has long made exorbitant profits by free-riding on research carried out by the public sector

Hooray for Pfizer! As news of a vaccine potentially offering 90% protection against Covid-19 offers a life raft for lockdown-weary humanity, perhaps those home-drawn posters on people’s windows thanking the NHS will soon be applauding big pharma instead.

The hope of a successful vaccine to liberate us from protracted economic misery should be embraced – but we should be sparing with the bunting for the pharmaceutical industry. If you want a particularly egregious case study of “socialism for the rich”, or of private businesses dependent on public sector research and innovation to make colossal profits, look no further than big pharma.

Related: The race to find a coronavirus treatment has one major obstacle: big pharma | Ara Darzi

Continue reading…

EU orders 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine

The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% of patients.

The companies said deliveries of an initial order of 200 million vaccines will be subject to approval by European regulators and are expected to start by the end of this year. There is an option for a further 100 million doses.

The vaccine supply for the EU will be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium and based on current projections, the companies expect to produce globally up to 1.3 billion doses in 2021.

Regulators sitting on the European Medicines Agency’s CHMP scientific committee have already begun a rolling review of the vaccine, which will accelerate the process as they will be able to study trial results as they are made available.

Vaccine doses for Europe will be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. If the BNT162b2 vaccine candidate receives approval from the European Medicines Agency (EMA), then doses will be ordered by the EU Member States who have elected to receive the vaccine as part of this agreement.

The Pfizer/BioNTech vaccine is based on mRNA, which instructs the body to produce the “Spike” protein on the surface of the SARS-CoV-2 coronavirus that causes COVID-19.

It does have one practical drawback as it must be stored at around -70C until the day it is used and there are already concerns this may make large scale vaccination schemes difficult.

The Independent reported that AstraZeneca’s rival vaccine, which is based on a viral vector and is also nearing the end of clinical development, could be easier to work with.

The AZ vaccine can be stored at fridge temperature, although there have been concerns about its safety after a late stage clinical trial was put on hold at the beginning of last month before resuming.

While Pfizer was keen to take the plaudits for developing a vaccine at speed from a standing start at the beginning of the year, it also faced uncomfortable questions about the conduct of its CEO Alfred Bourla.

It emerged that Bourla sold shares worth almost $5.6 million on Monday as part of a pre-planned sale on the day of the vaccine news release – which sent the company’s stock price soaring.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19

Shots:

  • The companies sign an agreement with the EC to supply 200M doses of BNT162b2 mRNA-based vaccine candidate against SARS-CoV-2 to EU member states, with an option to request an additional 100M doses
  • Deliveries are anticipated to start by the end of 2020, following clinical success and regulatory authorization. The companies expect to produce ~1.3B doses in 2021 globally
  • Pfizer and BioNTech initiated a rolling submission to the EMA in Oct’2020 and will continue a regular and open dialogue with the EMA providing results from their ongoing P-III study

Click here­ to­ read full press release/ article | Ref: Pfizer | Image: MedPage Today

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Why a Covid vaccine doesn’t mean the end of face masks yet | David Salisbury

Despite the Pfizer breakthrough, social distancing and remote working won’t disappear overnight

The news this week that the Pfizer/BioNTech vaccine protected more than 90% of recipients is of huge importance. The vaccine efficacy is higher than we had hoped for.

There appear to be no safety concerns, although the final safety data along with other data on manufacturing and the full efficacy results will need to be submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) to review whether it’s safe enough to grant temporary authorisation. This would allow the vaccine to be rolled out before a full product licence is issued.

Related: Speed trumps efficacy in UK’s Covid vaccine rollouts, says adviser

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Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Shots:

  • The P-lll JADE REGIMEN study involves assessing of Abrocitinib (100/ 200mg) vs PBO in 1233 patients aged ≥ 12 yrs. in a ratio (1:1:1) with mod. to sev. AD following response to initial open-label induction treatment with abrocitinib (200mg)
  • Result: The study met its 1EPs i.e. probability of not experiencing a flare @52wks. (81.1%, 57.4% vs 19.1%) and 2EPs i.e. patients maintain an IGA response of clear or almost clear relative
  • Following an initial 12wks. induction treatment phase, fewer patients experienced a flare at any point in the trial @40wks. Abrocitinib is a JAK inhibitor, which modulates multiple cytokines involved in the pathophysiology of AD, including IL-4, IL-13, IL-31, IL-22, and TSLP

Click here­ to­ read full press release/ article | Ref: Pfizer | Image: Forbes

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Where will poorer countries stand in the queue for a Covid-19 vaccine? | Clare Wenham and Mark Eccleston-Turner

The lion’s share of the potential Pfizer vaccine is already claimed by high-income nations

The news that joint efforts by the US pharmaceutical company Pfizer and the German biotech company BioNtech have produced a vaccine that is 90% effective at protecting people from Covid-19 has been understandably applauded – in spite of the caveats. Pfizer states that it can manufacture up to 50m doses by the end of 2020 and up to 1.3bn doses in 2021.

Given the desire to get life back to normal, these doses will be in incredibly high demand. Some governments around the world, including the UK, have already begun to indicate to their populations that they will receive a vaccine by Christmas. But how will the distribution of this finite number of vaccines work when we only have enough for one seventh of the global population?

Related: Pfizer and BioNTech’s vaccine poses global logistics challenge

Clare Wenham is assistant professor of global health policy at the LSE. Mark Eccleston-Turner is a lecturer in Global Health Law at Keele University

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Important questions about Pfizer’s Covid-19 vaccine

News of positive results from Pfizer’s Covid-19 vaccine is heartening but historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions, not through company press releases.

Pfizer chief sold $5.6m of shares on day Covid vaccine was announced

Pfizer said sale of shares by Albert Bourla was automated under plan set up in August

Pfizer’s chief executive sold shares in the company worth $5.6m (£4.2m) on the day the drugmaker announced that its Covid-19 vaccine was more than 90% effective in protecting people from transmission of the virus, triggering a surge in the company’s stock.

Albert Bourla sold 132,508 shares at $41.94 a share, equivalent to 62% of his shareholding in Pfizer, according to filings with the US Securities and Exchange Commission (SEC). This is close to the $41.99 peak the share price hit on Monday.

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Mini-nuclear plants may be an experiment worth exploring

Roll-Royce gave an eye-catching pitch but the economics of nuclear power needs further inspection

An energy white paper is in the offing, so consider Rolls-Royce’s pitch for the wonders of small modular reactors (SMRs) a piece of last-minute lobbying. After all, it is clear already that more nuclear, in combination with more offshore wind capacity, is likely to be judged a central way to meet the UK’s targets for cutting carbon emissions.

It’s an eye-catching pitch. “A domestic energy solution for the first time in a generation, with a product that is engineered, designed and manufactured in the UK,” as Tom Samson, the chief executive of the nine-member Rolls-led UK SMR consortium puts it. So not one of those mammoth £20bn-plus French-led and Chinese-backed Hinkley Point C constructions.

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UK security bill signals open door era for foreign takeovers is over

China’s ambition to build a nuclear plant in Essex will likely fail on national security grounds

The new national security and investment bill, aiming to give the government sweeping powers to block foreign takeovers and investments, will inevitably be viewed through the lens of China and new nuclear power plants in UK.

That is, indeed, one way to look at it. Even before the Huawei 5G saga and Beijing’s introduction of draconian security laws in Hong Kong, the mood had cooled on Chinese ownership of critical UK infrastructure.

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FTSE 100 recovers to highest level since June after vaccine unveiled

Promising clinical data from Pfizer and BioNTech help the index to a £28bn one-day gain

Optimism that a mass rollout of Covid-19 vaccines will lead to an economic recovery lifted stocks in London again on Tuesday, to their highest closing level in over four months.

London’s FTSE 100 index of blue-chip shares rallied by nearly 1.8% to finish at 6,296 points, the highest close since 23 June. This added £28bn to the index’s value, taking its gains so far this week to nearly £100bn after it surged 4.6% on Monday on news of a vaccine breakthrough.

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Pfizer and BioNTech could make $13bn from coronavirus vaccine

Johnson & Johnson and AstraZeneca pledged to make their vaccines available on a not-for-profit basis

The US drugmaker Pfizer and the German biotech firm BioNTech stand to bring in nearly $13bn (£9.8bn) in global sales from their coronavirus vaccine next year, which will be evenly split between the two companies, according to analysts at the US investment bank Morgan Stanley.

Pfizer’s half would be more than the US pharmaceutical group’s bestselling product, a pneumonia vaccine that generated $5.8bn last year.

Related: Pfizer and BioNTech’s vaccine poses global logistics challenge

Related: 6 key questions about the Pfizer/BioNTech Covid-19 vaccine

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Pfizer and BioNTech’s vaccine poses global logistics challenge

Europe and US create vast facilities for Covid-19 vaccine but poorer nations lack infrastructure say experts

Two vast football-pitch-sized facilities equipped with hundreds of large freezers in Kalamazoo, Michigan, and Puurs, Belgium, will be the centres of the huge effort to ship the coronavirus vaccine developed by US drug giant Pfizer and German biotech firm BioNTech, around the world.

Governments are scrambling to prepare for the rollout of the vaccine, which must be stored at -70C (-94F), after the announcement from the two companies that it was more than 90% effective and had no serious side-effects. The news sparked hopes of a return to normal life and a stock market rally, but now minds are turning to the practicalities of getting the vaccine quickly to populations across the world, in particular to the vulnerable people who need it most.

Related: 6 key questions about the Pfizer/BioNTech Covid-19 vaccine

The problem is particularly acute in the global south where many rural villages don’t even have a working vaccine fridge

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The Guardian view on the Covid vaccine breakthrough: making it work | Editorial

At last, there is hope of an end to this pandemic. Scientists appear to have performed an amazing feat, the rest of us must do our best too

Medicine is only partly a matter of science; it is, very much, the business of people. The inspiring news that a Covid vaccine appears within reach, with interim results showing the Pfizer/BioNTech candidate has 90% efficacy in protecting people from illness, reflects the extraordinary efforts of scientists this year. The speed with which this one has been developed – with others close behind – is remarkable. Detailed data has yet to be published, and much remains unknown, including how long individuals may be protected, whether it prevents infection and how effective it will be for older people, who are most vulnerable to Covid-19. There are still no guarantees it will be used, though manufacturing has begun. Nonetheless, this is a potentially transformative moment.

Now it is up to the rest of us to do our part. If this vaccine becomes available from the end of the year, as now looks likely, and others soon follow, the deployment will matter as much as its discovery. As one scientist has noted: “Vaccines don’t save lives. Vaccinations save lives.” Pfizer and BioNTech hope to make 50m doses available this year, but each patient requires two doses, and with the US, EU, UK and others all having placed advance orders, each country will get a tiny fraction of those it ultimately needs. Even if production of this vaccine is scaled up as planned, others will still be needed. The UK has a clear plan for who will be protected first, beginning with the oldest in society and those who care for them and thus might transmit the virus to them. Professor John Bell told MPs that there is a 70%-80% chance of having the most vulnerable covered by Easter if authorities “don’t screw up the distribution”. Mass inoculation will be a challenge; NHS England is planning seven-day services.

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Will enough people in the UK take the Covid-19 jab?

The UK usually has a high take-up for vaccines, experts say, but there are fears over misinformation and scepticism

The spread of scepticism and misinformation about coronavirus and the development of a vaccine for it has raised questions about whether it will pose a threat to the goal of achieving widespread immunity.

A report published on Tuesday by the British Academy and the Royal Society for the SET-C (Science in Emergencies Tasking: Covid-19) group said an 80% take up of a jab could be necessary in order for enough people to become immune to the virus and stop its spread. However, the actual threshold will depend on the efficacy of the vaccine, and the 90% achieved by the Pfizer/BioNTech candidate in trials was higher than many dared hope for.

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Cautious optimism over Covid-19 vaccine trials | Letters

Readers respond to news that an interim analysis has shown Pfizer/BioNTech’s vaccine candidate was 90% effective in protecting people from transmission of the virus in global trials

The media have been awash with stories about the apparent success of the Pfizer Covid vaccine following the publication of preliminary trial outcomes (Hopes rise for end of pandemic as Pfizer says vaccine is 90% effective, 10 November). I am not surprised that the public has latched on to these, as hope and positivity have been in short supply this past year. I have even had patients contacting me about when the vaccine will be available, stating that it will allow “normal” life to resume.

While the public can be forgiven for overoptimism, it is important that the medical profession, the media and the government keep expectations grounded and do not encourage the notion that we now have a panacea that will take us out of the pandemic.

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Despite the fine print, we can still feel optimistic about a Covid vaccine | Charlotte Summers

Pfizer’s preliminary results are a huge development, although hurdles still lie ahead

We could all do with some good news right now. After a long and difficult year of multiple lockdowns and numerous sacrifices, the announcement from Pfizer and BioNTech that preliminary results show their vaccine is 90% effective at protecting people from Covid-19 felt like the light at the end of the tunnel.

The announcement is based on interim results from phase 3 of a multinational, randomised controlled trial – considered the gold standard of clinical trials – involving 43,538 people. Each participant was given two doses of the vaccine or a placebo 21 days apart, to see if this would prevent them developing Covid-19. To date, 94 of those enrolled in the trial have developed confirmed Covid-19. The data suggests that just eight of these had been given the vaccine.

Related: If you’re pinning your hopes on a Covid vaccine, here’s a dose of realism | David Salisbury

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What does the Pfizer Covid vaccine breakthrough mean for Australia?

Interim results show vaccine to be 90% effective, but findings have not been peer-reviewed, Australia has only secured enough for five million people, and there are concerns around its storage temperature

• Pfizer says vaccine is 90% effective
What has Pfizer’s vaccine trial found?
Vaccine announcement is cause for cautious celebration

News that pharmaceutical giant Pfizer and partner company BioNTech have developed a vaccine that proved 90% effective in protecting people from Covid-19 in global trials has been heralded a “breakthrough”. Pfizer chief executive, Dr Albert Bourla, described the results as “a great day for science and humanity”.

But what do the findings mean for Australia, and for the other Covid-19 vaccines being researched?

Related: Hopes rise for end of pandemic as Pfizer says vaccine is 90% effective

Related: The race for a Covid vaccine: inside the Australian lab working round the clock to produce 100m doses

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Global markets: winners and losers as Covid vaccine hopes send shares surging

But the news highlighted divergences in fortunes across sectors during the pandemic

The FTSE 100 posted its biggest one-day gain since March on Monday after the drug companies Pfizer and BioNTech said their prospective coronavirus vaccine was 90% effective.

The news jolted global stock market indices to record levels but it also highlighted the stark divergences in fortunes across sectors during the pandemic. Those companies who gained from people spending their work and leisure time at home were among the biggest losers on Monday, while the vaccine news offered some welcome relief to previously hard-hit sectors such as travel and events.

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With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race

Finish line ahead

The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence in vaccines need to be boosted, an expert noted.

Pfizer/BioNTech vaccine announcement is cause for cautious celebration

Interim trial results are encouraging as scientists welcome news

It is not yet the end of the pandemic, but the announcement by Pfizer/BioNTech that their vaccine has been 90% successful in the vital large-scale trials has got even the soberest of scientists excited.

These are interim results and the trial will continue into December to collect more data. The two companies – a tiny German biotech with the big idea and the giant pharma company Pfizer with the means to develop it – have not yet published their detailed data, so it is all on trust. And yet, nobody is suggesting the results have been over-egged. It looks as though the vaccine not only works, but works better than anyone hoped.

Related: Covid-19 vaccine candidate is 90% effective, says Pfizer

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What has Pfizer’s Covid vaccine trial found and is this a breakthrough?

Early results from phase 3 trial look promising but there are still many questions to be answered

Pfizer and the German biotech company Biontech said on Monday that they had had encouraging early results from a phase 3 clinical trial of their coronavirus vaccine. The trial is assessing how well the vaccine works in preventing humans from becoming infected. Although details are scant, the news is positive.

Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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Global stock markets surge after Pfizer Covid vaccine news

FTSE 100 jumps as Pfizer and BioNTech report coronavirus vaccine is 90% effective

Global stocks have surged after the drug companies Pfizer and BioNTech announced that their coronavirus vaccine was 90% effective in tests, giving hope that economies around the world can soon return to normal.

The FTSE 100 soared on Monday by 5.5% to 6,242 points, up 332 points, its highest since mid-August. Most of the increase happened immediately after the vaccine announcement was first reported just before midday in London.

Related: Global stocks hit record high on Biden victory and Covid-19 vaccine news – business live

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Pfizer/BioNTech say vaccine works in 90% of COVID-19 patients

As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis.

The companies said they will be ready to file the vaccine with the FDA in the third week of November once they have enough safety data to meet the regulator’s requirements.

Top-line results come from a phase 3 trial of the candidate known as BNT162b2 and an evaluation of 94 cases from the trial of 43,538 patients.

The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at seven days after the second dose, the companies noted.

This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

The companies cautioned that as the study continues, the final vaccine efficacy percentage may vary.

The independent data monitoring committee that conducted the interim analysis said that there had been no serious safety concerns identified.

It recommended that the study continues to collect additional safety and efficacy data as planned.

Results will be discussed with regulators worldwide and the European Medicines Agency has already begun its rolling review of data to hasten a decision on the clinical trial dossier.

The phase 3 clinical trial of BNT162b2 began at the end of July and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020.

Around 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.

The vaccine is based on a strand of messenger RNA – a short segment of genetical material that codes for the “Spike” protein found on the surface of the coronavirus.

These cause the body to produce antibodies that neutralise the SARS-CoV-2 virus in the event of an infection.

Last month the companies aid that they are already producing hundreds of thousands of shots each day should the vaccine get approved.

However it remains to be seen whether countries such as the US and UK, which have ordered millions of shots, will be able to organise a mass vaccination programme after failing to implement track and trace measures that could also slow the spread of the disease.

Pfizer’s CEO Albert Bourla said: “Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.

“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

The vaccine is one of 47 in clinical development, according to the World Health Organization, showing several shots developed in China and a rival from the UK’s AstraZeneca are also close to reading out late-stage clinical results.

The pharma industry has developed vaccines for COVID-19 in record-breaking time after scientists from China published details of the SARS-CoV-2 virus shortly after the outbreak began in January.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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FTC clears Mylan merger with Pfizer’s Upjohn – with conditions

Mylan’s $12 billion takeover of Pfizer’s Upjohn unit has been cleared by the US authorities, but on the condition that the two companies divest various generic drug products.

The Federal Trade Commission (FTC) has ruled that the combined company – to be called Viatris – could have an anticompetitive position in the US market for seven generic drugs used for high blood pressure, heart failure, epilepsy, bacterial infections and uterine bleeding if the divestments don’t go ahead.

The FTC’s ruling means that Pfizer and Mylan have now obtained all the antitrust approvals needed for the merger to go ahead. Upjohn is now due to be spun off from Pfizer on 13 November, with the merger concluding three days later – around 16 months after first being announced. It was backed by the European Commission in mid-September.

Once formed, Viatris will be a generics behemoth with annual sales of around $19 to $20 billion and operations in 165 markets around the word. Mylan shareholders will hold approximately 43% of the new venture, with Pfizer investors taking 57%.

The deal is structured in a similar way to Pfizer’s joint venture with GlaxoSmithKline in consumer health, allowing the company to shed off lower-margin products whilst retaining an interest and generating cashflow to invest in its new product pipeline.

Mylan meanwhile will benefit from Upjohn’s greater global reach, allowing its generics to grow more quickly, according to the companies.

The generics that have to be divested include medroxyprogesterone, amlodipine besylate/atorvastatin, phenytoin, prazosin, spironolactone, gatifloxacin, and eplerenone products, according to the FTC.

Upjohn’s amlodipine besylate/atorvastatin, phenytoin, prazosin, spironolactone, gatifloxacin and medroxyprogesterone products must be divested to Prasco, and Mylan’s eplerenone product must also be shed.

The FTC was also concerned about three other drugs – sucralfate to treat and prevent ulcers in the small intestines, levothyroxine for hypothyroidism, and varenicline, the active ingredient in Pfizer’s smoking cessation brand Chantix.

The approval conditions also require a green light from the FTC before Pfizer, Mylan or Viatris may “gain an interest in, or exercise control over, any third party’s rights” to levothyroxine, sucralfate and varenicline tablets.

The divested products should continue to be manufactured by Upjohn and Mylan’s current suppliers in order to avoid any shortages in the market, and in some cases Pfizer will act as a contract manufacturer to Prasco.

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PharmaShots’ Key Highlights of Third Quarter 2020

The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B  Apart from acquisitions, big alliances were the highlights of the quarter which include Biogen collaboration with Denali on LRRK2 program for Parkinson’s Disease worth ~$2.125B, Sanofi’s agreement with Kymera to advance novel protein degrader therapies, Roche & UCB’s collaboration to develop UCB0107 for AD, Merck’s $4.5B oncology deal with Seattle Genetics. The third quarter of the year also showcases multiple approvals of the therapies which include Roche’s FDA’s approval for the VENTANA HER2 Dual ISH test as CDx, Genentech’ Gavreto (pralsetinib) got the US FDA’s approval for metastatic RET fusion-positive NSCLC. Meanwhile, AstraZeneca, J&J, and Novavax initiated the P-III development of their COVID-19 vaccine candidates. Our team at PharmaShots has summarized and complied with the insights of Q3’20.

Novavax Initiated P-III Study of its COVID-19 Vaccine in the UK

Date – Sept 25, 2020

Product – NVX-CoV2373

  • Novavax has initiated P-III study assessing the efficacy, safety and immunogenicity of NVX-CoV2373 vs PBO in Matrix-M in up to 10,000 individuals aged 18-84yrs. with/out relevant comorbidities, over the next 4-6wks.
  • Half the participants will receive two IM injections of vaccine comprising 5µg of protein antigen with 50µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive PBO
  • The 1EPs & 2EPs is the first occurrence of PCR-confirmed symptomatic COVID-19 & PCR-confirmed symptomatic mod. to sev. COVID-19 with the onset at least 7 days after second study vaccination in volunteers prior not infected with SARS-CoV-2 respectively. Novavax has continued to scale-up its manufacturing capacity, currently up to 2B annually

J&J Initiated Global P-III Clinical Study of its COVID-19 Vaccine

Date- Sept 24, 2020

Product- JNJ-78436735

  • The initiation of the ENSEMBLE trial follows positive interim results of P-I/IIa study demonstrating the safety and immunogenicity of JNJ-78436735 following a single vaccination. The results have been submitted to medRxiv and expected to be published imminently
  • The P-III ENSEMBLE study is design to assess the safety & efficacy of a single vaccine dose vs PBO in up to 60,000 adults aged ≥18yrs., including those that are over age 60. The trial will include both with/ out comorbidities associated with an increased risk for progression to severe COVID-19
  • The company will continue to ramp up its manufacturing capacity to meet its goal of providing 1B doses/year. J&J anticipates the first batches of a COVID-19 vaccine to be available for EUS in early 2021, if proven to be safe and effective

Illumina Acquired GRAIL for ~$8B

Date – Sept 22, 2020

Deal Value – ~$8B

  • Illumina to acquire GRAIL in cash & stock transaction for $8B including ~$3.5B in cash and $4.5B in shares of Illumina common stock. Illumina founded GRAIL in 2016 and later spun out it to develop state-of-the-art data science, ML and create the atlas of cancer signals in the blood, enabling multi-cancer early detection tests
  • GRAIL to receive CVR and future payments representing a pro rata portion of certain GRAIL-related revenues/ year for 12yrs., reflecting a 2.5% payment right to the first $1B of revenue each year for 12yrs. and 9% CVR if revenue is above $1B. Additionally, GRAIL to get the option to receive additional cash and/or stock consideration, prior to closing, in lieu of the CVR
  • The acquisition will transform cancer care using genomics and NGS platform and accelerates commercialization and adoption of transformative multi-cancer screening test with potential to detect cancer. GRAIL expects to launch Galleri in 2021 which can detect 50+ cancer indications

Fitbit to Launch ECG App in the US and EU in October 2020

Date – Sept 15, 2020

Product – ECG App

  • Fitbit’s ECG app has received the US FDA’s 510 (k) clearance and EC’s CE marking to assess heart rhythm for atrial fibrillation (AFib). The Fitbit ECG app will be available in Oct’2020 to the users on Fitbit Sense smartwatch
  • The company has launched a multi-site clinical trial across the US, to detect AFib from normal sinus rhythm and to generate an ECG trace, recording of a heart’s electrical rhythm, that is qualitatively like Lead I ECG. The study demonstrated that algorithm has an ability to detect 98.7% of AFib cases (sensitivity) and is 100% accurate in identifying study participants with normal sinus rhythm (specificity)
  • Fitbit Sense smartwatch is available today for pre-order on Fitbit.com with WW availability starting later this month and is available for $329.95 in carbon/graphite stainless steel and lunar white/soft gold stainless steel

Novartis’ Beovu (brolucizumab) Received EMA’s Approval for its Safety Label Update to Treat Wet Age-Related Macular Degeneration

Date – Sept 15, 2020

Product – Beovu (brolucizumab)

  • The EU label update includes additional categorization of retinal vasculitis and/or retinal vascular occlusion, usually in the intraocular inflammation. The approval follows Novartis completion of safety review and initiation of update to the Beovu prescribing information globally
  • The label update is applicable to all 27 EU member states as well as UK, Iceland, Norway, and Liechtenstein. Beovu is now approved for wet AMD treatment in 40+ countries including in the US, EU, UK, Japan, Canada, and Australia
  • Beovu (brolucizumab) is the clinically advanced humanized single-chain Ab fragment (scFv) which enhances tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics. Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors and mitigation of AEs

Gilead Acquired Immunomedics for ~$21B

Date – Sept 14, 2020

Deal Value – ~$21B

  • Gilead to acquire Immunomedics for $88.00/ share representing a 108% premium to Immunomedics’ closing price on Sept 11, 2020, making a total deal value $21B. The transaction is expected to be completed in Q4’20
  • The acquisition will add Immunomedic’s s Trodelvy to Gilead’s portfolio, expanding its oncology pipeline and accelerated its revenue and EPS growth. Additionally, the Trodelvy is being studied in an ongoing P-III study for 3L HR+/HER2- BC and a registrational P-II study in bladder cancer, NSCLC, and other solid tumors
  • Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed ADC, received accelerated approved for mTNBC in the US while the company plans to submit the sBLA for the full approval of the therapy in Q4’20. Immunomedics is on track to file for regulatory approval in EU in the H1’21

Merck Signed Up to $4.5B Oncology Deal with Seattle Genetics

Date – Sept 14, 2020

Deal Value – ~$4.5B

  • Seattle Genetics to receive $600M up front, $1B as equity investment, 5M shares of Seattle Genetics common stock at a price of $200/ share, $2.6B as milestones including $850M development milestones and $1.75B as commercial milestones. The companies will equally share costs and profits on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs
  • The companies will co-commercialize the therapy in the US and EU. Seattle Genetics will be responsible for approval in the US & Canada and will record sales in the US, Canada, and EU while Merck will be responsible for approval in EU & outside the US & Canada, and will record sales in countries outside the US, EU, and Canada
  • Additionally, companies enter exclusive license and co-development agreement to accelerate the global reach of Tukysa for HER2+ cancers in regions outside the US, EU & Canada. As per the agreement, Seattle Genetics to receive $125M as upfront and is eligible to receive up to $65M as progress-dependent milestones, $85M as research and development milestones, and royalties on sales of Tukysa in Merck’s territory

Novartis’ Kisqali (ribociclib) Received Highest Score on the ESMO Magnitude of Clinical Benefit Scale

Date – Sept 11, 2020

Product – Kisqali (ribociclib)

  • Novartis’ Kisqali + endocrine therapy has achieved 5 out of 5 score on ESMO-MCBS, confirming substantial benefit for premenopausal women with HR+/HER2- aBC, based on OS benefit and improved QoL in the P-III MONALEESA-7 study
  • Kisqali is also the only CDK4/6 inhibitor to receive a score of 4 out of 5 in combination with fulvestrant  for 1L postmenopausal women with HR+/HER2- aBC based on the OS benefit and maintained QoL observed in P-III MONALEESA-3. Additionally, Kisqali + fulvestrant receive a score of 4 out of 5 in 2L setting based on the MONALEEA-3 study
  • New data presented at ESMO 2020 add to the substantial body of evidence further differentiating Kisqali as the only CDK 4/6 inhibitor that improves OS in two P- III trials, with consistent results across patient subgroups, and with QoL benefits. Kisqali in patients with endocrine resistance led to a 30% & 41% reduction in the risk of death in the MONALEESA-3 & -7 studies over standard endocrine therapy respectively

AbbVie Licensed I-Mab’s Lemzoparlimab (TJC4) for ~$2B

Date – Sept 09, 2020

Deal Value – ~$2B

  • I-Mab to receive $180M upfront, $20M on P-I results and is eligible to receive $1.74B which include $840M as development & regulatory milestones while remaining as commercial milestones along with royalties on sales of the therapy outside China
  • AbbVie to get an exclusive global license (Ex-greater China) to develop and commercialize lemzoparlimab while I-Mab retain its right in China. Both the companies will conduct clinical trials to evaluate lemzoparlimab in multiple cancers while each partner have the potential to expand the collaboration to additional transformative therapies
  • The companies will have the opportunity to further licenses to explore each other’s related programs in their respective territories. Lemzoparlimab is an anti-CD47 mAb, designed to minimize inherent binding to normal RBCs while preserving its strong anti-tumor activity

Genentech’ Gavreto (pralsetinib) Received the US FDA’s Approval Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Date – Sept 07, 2020

Product – Gavreto (pralsetinib)

  • The approval is based on P-I/II ARROW study assessing Gavreto (400mg, qd) in RET fusion-positive NSCLC patients with or without prior therapy, and regardless of RET fusion partner or CNS involvement. The study also involves patients with RET-MTC, RET fusion-positive thyroid cancer and other RET-altered solid tumors
  • Results: ORR (57%) and CR rate (5.7%) in 87 NSCLC patients prior treated with Pt. based CT, m-DOR was not reached, in 27 treatment-naïve NSCLC patients, ORR (70%); CR rate (11%). Gavreto is now the 6th FDA-approved medicine in Genentech’s portfolio for lung cancer
  • Gavreto is an oral precision therapy targeting RET alterations, including fusions and mutations, regardless of the tissue of origin. Additionally, the US FDA has granted BT designation for RET fusion+ NSCLC and RET mutation+ MTC and PR for advanced or m-RET-mutant MTC and RET fusion+ thyroid cancer to the therapy with its anticipated PDUFA date as 28 Feb, 2021

AstraZeneca Expanded the Development of AZD1222 into P-III Study in the US Across All Adult Age Groups

Date- Sept 01, 2020

Product- AZD1222

  • AstraZeneca has expanded the development of AZD1222 into P-III D8110C00001 study to assess it safety, efficacy and immunogenicity. BARDA has funded the P-III study to accelerate the development of the vaccine
  • The P-III D8110C00001 study involves assessing of AZD1222 vs PBO for the prevention of COVID-19, in up to 30,000 participants aged ≥ 18yrs. in a ratio (2:1) across ~100 trial centers in and outside the US. Participants are being randomized to receive two doses of either AZD1222 or a saline control, 4wks. apart, with twice as many participants receiving the potential vaccine than the saline control
  • The company is evaluating the AZD1222 globally with late-stage clinical trials ongoing in the UK, Brazil, and South Africa, while the trials are planned to start in Japan and Russia

GSK and VIR Biotechnology Initiated P-II/III COMET-ICE Study of VIR-7831 Against COVID-19

Date- Sept 01, 2020

Product- VIR-7831

  • The first patient has been dosed last week in a P-II/III COMET-ICE study with VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization
  • The study will enroll ~ 1,300 patients globally who have early symptomatic infection. The P-II/III study comprises of two parts: The Lead-In phase will assess the safety and tolerability of VIR-7831 (IV, 500mg) vs PBO over a 14-day period in non-hospitalized patients and aims to recruit 20 patients across the US
  • Following this initial safety assessment, the Expansion phase will assess the safety and efficacy VIR-7831 (IV) vs PBO in ~1,300 non-hospitalized participants globally. The company expects the results in Q1’21 and early access to the Ab treatment in H1’21

World’s First App-Based Nicotine Addiction Treatment Received the MHLW’s Approval in Japan

Date – Aug 31, 2020

Product – CureApp

  • On Aug 21, 2020, CureApp receive MHLW’s approval for the manufacturing and sale of Asia’s first therapeutics app, the “CureApp SC Nicotine Addiction Treatment App and CO Checker’’. The company plans to receive insurance reimbursement and release CureApp SC in FY2020
  • CureApp SC is a prescription medical device designed to aid patients receiving outpatient smoking cessation treatment and supports patients to quit smoking in a home setting. The product consists of three components – a patient app, a doctor app, and a portable CO Checker
  • The patient app can provide personalized guidance and is used in tandem with the portable CO Checker, allowing patients to accurately measure the concentration of CO in their breath at home. The patient’s condition obtained from the patient app and the CO Checker will be shared with doctors via the doctor app

GSK’s Blenrep (belantamab mafodotin) Received EC’s Approval for R/R Multiple Myeloma

Date – Aug 27, 2020

Product – Blenrep (belantamab mafodotin-blmf)

  • The EC’s approval is based on DREAMM-2 study assessing Blenrep (2.5/ 3.4 mg/kg, q3w) as monothx. in adult patients prior treated with 4 therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 mAb, and who have demonstrated disease progression on the last therapy
  • The data demonstrated that Blenrep (2.5 mg/kg dose, q3w) resulted in 32% ORR, mDoR (11mos.) & mOS (13.7mos.) while the safety and tolerability profile is consistent with previous data of the therapy
  • Blenrep is a BCMA mAb conjugated to the cytotoxic agent auristatin F via a non-cleavable linker and has received EMA’s PRIME designation in 2017

Novartis’ Kesimpta (ofatumumab) Received the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Date – Aug 21, 2020

Product – Kesimpta (ofatumumab)

  • The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and a Sensoready pen in patients with RMS
  • ASCLEPIOS I & II studies results: reduction in ARR 51% & 59% (0.11 vs 0.22 & (0.10 vs 0.25), 34% reduction in 3mos CDP, reduction in number of Gd+ T1 (98% & 94%) and new/ enlarging T2 lesions (82% & 85%) respectively
  • In a post hoc analysis, Kesimpta may halt new disease activity in RMS with 47.0% & 7.8% of patients achieved (NEDA-3) within (0–12mos.) and (12–24 mos.) of treatment, respectively. The therapy is expected to be available in the US in early Sept’2020 along with its anticipated EU approval in Q2’21

Johnson & Johnson Acquired Momenta Pharmaceuticals for $6.5B

Date – Aug 19, 2020

Deal Value – ~$6.5B

  • J&J acquires Momenta in all cash transaction at a price of $52.50/ share, making a total deal value as $6.5B. The transaction is expected to be closed in H2’20
  • The acquisition allows J&J to expand its portfolio for autoimmune diseases with the addition of Momenta’s Nipocalimab (M281) to its pipeline. In addition to nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets
  • Janssen plans to retain Momenta’s presence in Cambridge, Massachusetts which will increase J&J footprint and capabilities in key innovation hub. Nipocalimab provides an opportunity for Janssen to deliver transformative treatments in autoantibody-driven autoimmune diseases

Sanofi Acquired Principia Biopharma for ~$3.68B

Date – Aug 17, 2020

Deal Value – ~$3.6B

  • Sanofi to acquire Principia Biopharma in all stock transaction, at $100/share making total deal value ~$3.68B in cash. The transaction is expected to be completed in Q4’20
  • The focus of the acquisition is to strengthen its R&D areas of autoimmune and allergic diseases with the expansion of SAR442168 development program into CNS disorders. Additionally, the deal also adds rilzabrutinib to Sanofi’s portfolio of immunology and inflammation indications
  • The Principia’s BTK inhibitor ‘168 is developed using its Tailored Covalency platform and was evaluated in P-IIb study for MS leading reduction of 85% Gd-enhancing T1 hyperintense lesions vs PBO. In 2017, Sanofi signed exclusive WW license agreement with Principia to develop and commercialize BTK inhibitor ‘168 in MS and other CNS diseases

Zydus Launched Cheapest Version of Remdesivir at $37.41 per Vial in India

Date – Aug 13, 2020

Product – Remdesivir

  • The company has launched Remdec at a price of $37.41 (Rs. 2800) for a 100mg lyophilized injection. The generic version is the most economical Remdesivir brand in India
  • In Jun’2020, Zydus signed a non-exclusive agreement with Gilead to manufacture and commercialize Remdesivir for severe COVID-19 in India. The API of the therapy has been developed and manufactured at the group’s API manufacturing facilities in Gujarat
  • The drug will be made available across India via Zydus’ strong distribution chain reaching out to government and private hospitals treating COVID patients

Biogen Signed an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B

Date – Aug 07, 2020

Deal Value – ~$2.125B

  • Denali to receive $560M up front, $465M as equity investment at a price of $34.94/ share, representing 11.2% of Denali’s pro-forma outstanding stock along with $1.125B as milestones.
  • The two companies will codevelop Denali’ LRRK2 inhibitor for PD and co-commercialize it the US and China while Biogen have the right to commercialize the therapy in other territories and will pay royalties for the same. Biogen & Denali will share global development cost (60% & 40%) with equal share in profit and loss in the US and in China (60% & 40%) respectively
  • Denali’ LRRK2 inhibitor (DNL151) has been progressed into late stage clinical studies expected to commence in 2021. Additionally, Biogen to receive exclusive option rights to two programs for neurodegenerative diseases utilizing Denali’s TV technology platform, including for amyloid beta + right of first negotiation for two additional unnamed TV platform programs

Siemens Healthineers Acquired Varian for $16.4B

Date – Aug 04, 2020

Deal Value – ~$16.4B

  • Siemens Healthineers to acquire Varian in all-cash transaction, at a price of $177.50/ share with 42% to the 30-day volume weighted average closing price of Varian’s common stock as of July 31, 2020, making a total deal value ~$16.4B
  • The transaction is expected to be closed in H1’21. The combined company will offer an integrated platform of end-to-end oncology solutions to addressing the complete continuum of cancer care, from screening and diagnosis to care delivery and post-treatment survivorship
  • Varian and Siemens Healthineers will lead the digital transformation of oncology healthcare, enabling more efficient diagnosis, increased treatment quality and access, personalized precision cancer care, and improved outcomes for millions of patients worldwide

Sanofi and GSK Received $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

Date – Aug 03, 2020

Value – $2.1B

  • The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine
  • The US government has an option to supply an additional 500M dose and helps the government’s Operation Warp Speed goals for providing millions of doses of a safe and effective COVID-19 vaccine
  • Additionally, the companies are in discussion with the EC for the supply of up to 300M doses of a COVID-19 vaccine. Both the companies are committed to making their COVID-19 vaccine affordable and available globally

Roche’s Actemra/RoActemra (tocilizumab) Failed to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Date – Jul 29, 2020

Product – Actemra/RoActemra (tocilizumab)

  • The P-III COVACTA study involves assessing of Actemra/RoActemra (IV) + SOC vs PBO + SOC in adult patients hospitalized with severe COVID-19 associated pneumonia. Patients will be followed for 60 days post randomization
  • The study did not meet its 1EPs i.e. improvement in clinical status and 2EPs i.e. difference in patient mortality @4wks. (19.7% vs 19.4%); median time to discharge (20 vs 28days); rate of infection (38.3% vs 40.6%); rates of serious infections (21.0% vs 25.9%)
  • Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both in IV/ SC formulations for the treatment of adult patients with moderate-to-severe active RA. Roche will continue the clinical study of Actemra in other treatment settings including in combination with an antiviral

Roche and UCB Collaborated to Develop UCB0107 for Alzheimer’s Disease

Date- Jul 29, 2020

Deal Value- ~$2B+

  • UCB to receive $120M and is eligible to receive $2B as cost reimbursement, development and commercial milestones as well as royalties on sales of the therapies, if Roche proceed the clinical development. Roche to get an exclusive license to develop and commercialize UCB0107 for AD
  • UCB to fund and perform a POC study in AD and, upon availability of the results of that study while Roche has the right to progress with the development or return full rights back to UCB
  • UCB0107 is an IgG4 mAb targeting a central Tau epitope, being developed to block/reduce the spread of Tau pathology. UCB continues to develop UCB0107 in PSP, with anticipated initiation of P-III study in Q2’21

AstraZeneca Signed an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Date – Jul 27, 2020

Deal Value – ~$6B

  • Daichii Sankyo to receive $1B as upfront of which $350M is due upon execution, $325M after 12mos. and $325M after 24 mos., ~$5B as contingent payment including $1B as regulatory milestones, and $4B as commercial milestones, making a total deal value up to ~6B
  • The companies will jointly develop and commercialize DS-1062 globally and share equal development & commercialization costs, except in Japan where Daiichi Sankyo will maintain exclusive rights and manufacture and supply DS-1062
  • Daiichi Sankyo is expected to book sales in US, certain EU countries, and other markets where the company has affiliates while AstraZeneca is expected to book sales in other markets globally, including China, Australia, Canada, and Russia. DS-1062 is a TROP2 directed DXd ADC, currently in P-I study for NSCLC and TNBC

Sanofi Signed an Agreement with Kymera to Advance Novel Protein Degrader Therapies Worth Up to $2.1B

Date – Jul 10, 2020

Deal Value – ~$2.1B

  • Kymera to receive $150M up front, $2B as development, regulatory and commercial milestones along with royalties on sales of therapies. Additionally, the company has an option to develop and commercialize the two programs in the US while retaining global rights to its IRAK4 program in oncology indications.
  • Sanofi will get a global right to develop and commercialize protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases and a second undisclosed preclinical program
  • Kymera will advance the IRAK4 program through P-I study, afterwards Sanofi will be further responsible for its development and will lead all clinical development activities for the second program. IRAK4 is a key protein involved in inflammation mediated by the activation of TLRs and IL-1Rs

Bausch Health Spun off its Eye Health Business

Date – July 08, 2020

Product – N/A

  • Bausch Health spin off its leading eye health business into an independent publicly traded company under the name Bausch + Lomb. The spinoff is expected to be completed in H1’21
  • The spinoff will lead to the formation of two separate companies that include an eye-health company built on the iconic Bausch + Lomb brand and a diversified company with leading positions in gastroenterology, aesthetics/dermatology, neurology, and international pharmaceuticals
  • Bausch + Lomb will consist of Bausch Health’s global vision care, surgical, consumer and ophthalmic Rx businesses which had generated $3.7B revenue in 2019. The other company would comprise brands across the Salix, International Rx, neurology, and medical dermatology businesses that generated a revenue of ~$4.9B in 2019

Roche Signed a ~$1B Agreement with Blueprint Medicines for its Precision Therapy to Treat Patients with RET-Altered Cancer Indications

Date – Jul 07, 2020

Deal Value – ~$1B

  • Blueprint Medicine to receive $675M as up front, $100M as equity investment and is eligible to receive up to $927M as development, regulatory and commercial milestones along with royalties on sales of therapy outside the US
  • Roche to get an exclusive right to co-develop globally and commercialize pralsetinib outside the US, excluding Greater China. In the US, Roche will get co-commercialization rights to pralsetinib. The companies will share global development expenses based on pre-specified cost-sharing percentages and equally share profits and losses in the US
  • Pralsetinib (qd, PO) is precision therapy for the treatment of patients with RET-altered NSCLC, MTC and other types of thyroid cancer, and solid tumors and has demonstrated tumour-agnostic potential with its PDUFA date as Nov 23, 2020

Merck KGaA and Pfizer’s Bavencio (avelumab) Received the US FDA’s Approval as a 1L Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

Date – Jul 01, 2020

Product – Bavencio (avelumab)

  • The approval is based on P-III JAVELIN Bladder 100 study assessing Bavencio (10 mg/kg, IV infusion, q2w) + BSC vs BSC as monothx. in 700 patients with LA/ m-UC whose disease had not progressed after 1L platinum-based induction CT as per RECIST v1.1
  • Results: median OS (7.1 vs 21.4mos.); improvement in OS represents a 31% reduction in the risk of death in the overall population, in PD-L1+ patients (44% reduction in risk of death), in an exploratory analysis of patients with PD L1 negative tumors, OS hazard ratio (0.85)
  • Priority review of the therapy was completed under FDA’s Real-Time Oncology Review (RTOR) pilot program, following the receipt of BT designation. In 2017, the US FDA approved the therapy under the accelerated approval program and now converted it to a full approval

The post PharmaShots’ Key Highlights of Third Quarter 2020 first appeared on PharmaShots.

FDA sets April verdict for Pfizer’s “underestimated” atopic dermatitis drug

Pfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in atopic dermatitis, a drug that CEO Albert Bourla believes hasn’t been given the credit it is due by Wall Street analysts.

The US regulator has started a priority review of abrocitinib for mediate to severe atopic dermatitis in patients aged over 12, setting up a decision next April, while the EMA has also started a standard review that could lead to approval in the EU in the second half of 2021.

Bourla told analysts on Pfizer’s results call yesterday that abrocitinib is “the one potential near-term compound where we see the biggest difference compared with consensus.”

Pfizer sees abrocitinib and other JAK drugs coming through the pipeline for atopic dermatitis as expanding the number of patients getting treatment for the more severe end of the spectrum of symptoms – and it reckons that unlocks blockbuster sales potential.

“This is not a zero-sum game with the biologics in the treatment of moderate to severe atopic dermatitis,” said Bourla.

These patients currently rely on biologic drugs like Sanofi and Regeneron’s Dupixent (dupilumab), which dominates the category and saw sales rocket to more than $2 billion last year.

Sanofi sees plenty of additional upside, suggesting the drug could become a $10 billion brand at peak from expansion in atopic dermatitis as well as new indications like asthma, chronic rhinosinusitis with nasal polyps and eosinophilic oesophagitis.

Abrocitinib has previously been shown as effective in the JADE-MONO-1 and JADE-MONO-2 trials in subjects aged over 12, with a profile that looks like it could challenge its biologic rivals.

In particular, Pfizer says the drugs seem to have an impact on itch – often cited as the most bothersome symptom by atopic dermatitis patients.

Bourla and Angela Hwang – group president of Pfizer’s biopharmaceuticals division – think analysts are overlooking the sheer scale of atopic dermatitis as a condition with around 60 million sufferers aged over 12 worldwide.

They are also discounting abrocitinib’s profile, and the fact that almost two-thirds of patients treated with Dupixent don’t achieve clear or almost clear skin at 16 weeks, leaving room for improvement.

“Of those 60 million, only 7% of them today are being treated with a systemic agent,” said Hwang on the call. “So the systemic market opportunity has real potential to more than double with the introduction of better systemic treatment, because the patient need is just so high.”

There’s a precedent for that level impact for new biologic drugs such as interleukin inhibitors for psoriasis, which doubled the market over a 10-year period.

Claiming just 8% of the systemic atopic dermatitis treatment market would equate to $3 billion in abrocitinib sales, said Hwang.

Pfizer’s drug seems to have a lead in atopic dermatitis over other JAK inhibitors, although AbbVie has trials on the go for its fast-growing Rinvoq (upadacitinib) rival in this indication – including a head-to-head comparison with Dupixent due to read out next year.

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Sidekick Health raises $20m to fund digital therapeutics expansion

Gamified digital therapeutics firm Sidekick Health has raised $20 million in a Series A funding round, which it plans to use to develop its product offering.

Based in Iceland, Sidekick said the oversubscribed funding round was led by Wellington Partners and Asabys Partners through its SAHII fund, with existing investors Novator and Frumtak Ventures.

The funding will be used to grow operations in Europe and the US, Sidekick said in a statement.

Sidekick specialises in developing gamified digital therapeutic solutions and programs aimed at managing chronic diseases, as well as encouraging users to proactively stave off onset with healthier lifestyles.

Therapeutic areas range from diabetes to ulcerative colitis and smoking cessation.

Proceeds help validate products and expand the company’s reach into new therapeutic areas and further its efforts in patient engagement and retention.

Dr Regina Hodits, managing partner at Wellington, and Josep Sanfeliu, partner and co-founder of Asabys will join Sidekick’s board following the fundraiser.

Fundraising efforts were supported by the EIT Digital Accelerator and it went on to be selected by EIT Digital as one of Europe’s ten best deep technology scale-ups.

EIT Digital is an innovation and entrepreneurial organisation that has supported start-up and scale-up companies, which have collectively raised 900 million euros.

Sidekick was founded by two medical doctors – Dr Tryggvi Thorgeirsson and Dr Saemundur Oddsson – who had worked for years treating tens of thousands of patients with lifestyle-related illnesses.

The company combines an evidence-based clinical approach with behavioural economics and gamification and is already working with big pharma clients including Pfizer.

This year’s COVID-19 pandemic has seen an increase in investment in digital health technology.

A quarterly report on the sector from Rock Health showed digital health-focused venture capital firms reported $4 billion in US-based digital startup investments during Q3 alone.

This brings the fundraising total to $9.4 billion for the first nine months of the year, already well ahead of the previous annual record set in 2018 of $8.2 billion.

However according to Rock Health M&A activity in the sector is down by volume – there were 63 acquisitions in the first nine months of this year, while in 2019 there were 113 for the whole year.

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COVID-19 bites into Pfizer’s Q3, but biopharma revenues rise

Pfizer is one of the front-runners in the race to approve a COVID-19 vaccine but the US company has had to weather lower revenues for the third quarter due to the ongoing impacts of COVID-19. Despite the decline, biopharma revenues increased overall.

Total third-quarter 2020 revenues hit $12.1 billion, a decrease of $549 million, or 4%, compared to last year

The company estimates an unfavorable impact of approximately $500 million due to COVID-19, primarily driven by lower demand for some products in China and disruptions to wellness visits for patients in the US, which negatively impacted prescribing patterns for certain products.

One surprise positive impact of the pandemic was an uptake of Pfizer’s blockbuster pneumonia vaccine Prevenar 13 due to increased vaccine awareness for respiratory illnesses.  The shot will soon face competition from Merck & Co.

Overall, biopharma revenues grew over the quarter, rising to $10.2 billion, an increase of 4% from last year. This was primarily driven by transthyretin amyloid cardiomyopathy (ATTR-CM) drug Vyndaqel/Vyndamax, which had global revenues of $351 million (up 125%), as well as novel anticoagulant Eliquis (apixaban), JAK inhibitor Xeljanz (tofacitinib) and prostate cancer drug Xtandi (enzalutamide).

Meanwhile, global biosimilar revenues jumped 80% to $424 million, driven by recent oncology biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) in global markets.

Enbrel revenues, however, fell 21% internationally due to biosimilar competition in developed Europe markets, as well as in Japan and Brazil. COVID-19 drove down hospital business sales in markets such as China due to lower infection rates driven by fewer elective surgical procedures, shorter in-patient hospital stays and improved infection control.

Pfizer also announced that is cutting three drugs from its pipeline.

The first is phase 2 drug PF-05221304, aimed at nonalcoholic steatohepatitis (NASH), a notoriously difficult disease area to develop drugs for. The drug had been given FDA fast track designation. No reason was given for the cut, but the drug is still in active combination trials, suggesting that will be the future of the compound.

Meanwhile, arthritis drug PF-06650833 was also cut, and the prostate cancer vaccine PF-06753512 seems to be sharing the fate of other cancer vaccines that haven’t made it out of phase 1. 

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Moderna nears COVID-19 vaccine finish line as it wraps up study enrolment

Moderna is close to completing its phase 3 trial of COVID-19 vaccine candidate mRNA-1273 after completing recruitment of the 30,000 subjects in the trial.

It’s also revealed that more than 25,000 of them have already received the second dose of the shot in the COVE study, putting it in contention to be the first coronavirus vaccine company to be ready to file for emergency use authorisation in the US.

As with all COVID-19 vaccines, Moderna will need two months of safety data following the final vaccine dose before it will be able to file for an EUA, but the milestone puts it just behind Pfizer and BioNTech in the race to that objective with a possible filing date in early December.

Shares in the company climbed nearly 5% after the announcement continuing an upwards trend that means the stock is now trading at almost four times its value at the start of the year.

The latest milestone follows a rolling reviews of mRNA-1273 in Canada, which allow the country’s regulator to start reviewing data as it becomes available, and Moderna is now gearing up to file via  similar mechanism in Europe.

Moderna shared demographic data from the study at an FDA committee meeting today which showed that it included some of the groups most at risk from COVID-19.

That includes 7,000 people aged over 65 and more than 5,000 younger people with chronic diseases that make them more likely to get severe symptoms like diabetes and obesity, while around a third of subjects of African American, Hispanic/Latin and Asian descent.

Last month, Moderna said it was slowing enrolment in COVE to “ensure the representation of…communities of colour, ” and on that measure it seems to have an advantage over Pfizer/BioNTech’s BNT162b2 vaccine, which completed phase 3 recruitment in mid-September but has only 25% ethnic minorities.

Studies have suggested that that black and minority ethic people are at higher risk of dying from COVID-19 than the rest of the population.

The study – funded with the help of $955 million of US government money – is comparing two 100 µg doses of mRNA-1273 given by intramuscular injection 28 days apart to a matched placebo, and the primary endpoint is the prevention of symptomatic COVID-19 disease 14 days after the second administration.

Like Pfizer/BioNTech and other coronavirus vaccine developers, Moderna has committed to ensuring that it has full safety and efficacy data available before filing for an EUA.

If COVE is positive and mRNA-1273 gets approved, Moderna has said it is on track to deliver up to 500 million doses per year, and possibly up to a billion doses per year beginning in 2021, thanks to a manufacturing collaboration with Lonza.

Initially supplies will be much more limited of course, and the US has already placed orders for 100 million doses of mRNA-123 in a $1.5 billion deal agreed in August.

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Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or heal the condition by modifying the way the immune system is working or, in the case of vaccines, instructing the immune system and enhancing the immune reaction to specific pathogens. In the top 20 ledgers, AbbVie again ensured the top position with total revenue of $19.57B with its blockbuster drug, Humira (adalimumab) from its immunological segment. Our team at PharmaShots has compiled a list of the top 20 immunology companies based on their 2019 immunology revenue

Immunology Segment Revenue: $0.01B

Founded Year: 1979

Market Cap: ~ $0.49B

Total Employees: ~178

Headquarter: New Jersey, United States

Stock Exchange: NASDAQ

Antares Pharma is an American pharmaceutical company focus on developing and commercializing therapies for rheumatology, urology, endocrinology, and neurology. Antares has reported a total sale of $0.01B from its immunology segment in 2019

Immunology Segment Revenue: $0.24B

Founded Year: 2008

Market Cap: ~$15.70B

Total Employees: ~1,200

Headquarter: Dublin, Ireland

Stock Exchange: NASDAQ

Horizon Therapeutics is an Ireland based biopharmaceutical company focused on developing and commercializing therapies for the treatment of gout, rheumatoid arthritis, and rare diseases. Horizon has generated the sale of $0.24B from its four approved immunology products including Tepezza, Rayos, Duexis and Vimovo. Horizon’s Tepezza was selected for “2020 R&D World R&D 100 Award”

Immunology Segment Revenue: $0.49B

Founded Year: 1993

Market Cap: ~$2.57B

Total Employees: ~5,047

Headquarter: Shenyang, China

Stock Exchange: HKD

3SBio is a fully integrated Chinese biotechnology company with market-leading biopharmaceutical franchises in oncology, auto-immune diseases, nephrology, metabolic diseases, and dermatology. There are three approved drugs in its immunology portfolio including Yisaipu, Tpiao and Xenopax. 3SBio’s Tpiao used to treat chemotherapy-induced thrombopenia (approved in 2005) and immune thrombocytopenia has generated global sales of $0.33B in 2019.

Immunology Segment Revenue: $0.73B

Founded Year: 1978

Market Cap: ~$42.57B

Total Employees: ~7,400

Headquarter: Massachusetts, United States

Stock Exchange: NASDAQ

Biogen is a global biopharma company focused on neurology, hematologic, and autoimmune diseases. Biogen has a total of six products in its immunology segment with four approved drugs including Tysabri, IMRALDI, FLIXABI, BENEPALI. Biogen’s lead drug Tysabri recorded a revenue of $1.89B. Biogen revealed the positive result of BIIB059 in the Phase 2 LILAC study for cutaneous lupus erythematosus and systemic lupus erythematosus.

Immunology Segment Revenue: $0.81B

Founded Year: 2000

Market Cap: ~$88.14

Total Employees: ~99,000

Headquarter: Brentford, United Kingdom

Stock Exchange: LON

GlaxoSmithKline (GSK) is a global healthcare company serving the world with drugs, vaccines & consumer healthcare products. With only approved products, Benlysta, GSK has generated a revenue of $0.81B in 2019. In Jul 2019, GSK initiated the phase 3 study of otilimab for rheumatoid arthritis. In Sep’19, EMA granted a positive CHMP opinion for intravenous Benlysta in children with lupus and was approved in Oct 2019.

Immunology Segment Revenue: $1.11B

Founded Year: 2007

Market Cap: ~$34.6B

Total Employees: ~7,228

Headquarter: Osaka, Japan

Stock Exchange: TYO

Mitsubishi Tanabe is a Japanese pharma company focused on autoimmune diseases, diabetes and kidney diseases, neurological disorders, and vaccines. Mitsubishi has reported a total sale of $1.11B from its immunology segment in 2019.

Immunology Segment Revenue: $1.24B

Founded Year: 1891

Market Cap: ~$197.46B

Total Employees: ~71,000

Headquarter: New Jersey, United States

Stock Exchange: NYSE

Merck & Co. is a global health care company delivering innovative health care products with its Prescription medicines, Oncology drugs, Vaccines, Biologic therapies, and Animal Health care products. Merck has recorded the sale of $1.24B in 2019 from its five approved drugs in its immunology portfolio including Simponi, Remicade, Renflexis, Brenzys, Hadlima. Simponi and Remicade was co-commercialized by Merck and Johnson & Johnson and Simponi recorded the revenue of $0.83B in 2019.

Immunology Segment Revenue: $1.68B

Founded Year: 1991

Market Cap: ~$19.38B

Total Employees: ~1,300

Headquarter: Delaware, United States

Stock Exchange: NASDAQ

Incyte Corp is a global biopharmaceutical firm focused on developing therapies in two categories Oncology and Inflammation & Autoimmune. Incyte has generated a revenue of $1.68B from its immunological segment. In Jan’19, Incyte reports results of Itacitinib in GRAVITAS-301 P-III study for patients with treatment-naive acute graft-versus-host disease.

Immunology Segment Revenue: $1.79B

Founded Year: 2005

Market Cap: ~ $26.49B

Total Employees: ~15,883

Headquarter: Tokyo, Japan

Stock Exchange: TYO

Astellas Pharma is a Japanese multinational pharmaceutical company focused on the therapeutic fields of urology, immunology including transplantation and infectious diseases, oncology, neuroscience and DM complications, and metabolic diseases. Astellas has four drugs in its immunology portfolio including two approved drugs Smyraf And Prograf and has recorded the sale of $1.79B in 2019. In Jul’19, Astellas Pharma launched Smyraf 50 mg and 100 mg tablets for rheumatoid arthritis.

Immunology Segment Revenue: $1.79B

Founded Year: 1901

Market Cap: ~$135.16B

Total Employees: ~33,625

Headquarter: Indiana, United States

Stock Exchange: NYSE

Eli Lilly and Company is a global pharmaceutical firm focused on delivering therapies in two divisions Human Pharmaceutical Products and Animal Health products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. Eli Lilly has two approved drugs including Taltz and Olumiant. Lilly’s Taltz, an approved drug for plaque psoriasis or psoriatic arthritis has generated a revenue of $1.6B in 2019. In Apr’19, Eli Lilly signs research and licensing agreement with avidity biosciences to develop therapies in immunology.

Immunology Segment Revenue: $1.92B

Founded Year: 1928

Market Cap: ~$20.49

Total Employees: ~7,600

Headquarter: Brussels, Belgium

Stock Exchange: EBR

UCB is a global biopharmaceutical company focused on neurology, inflammatory, gastrointestinal and autoimmune disorders. UCB has recorded the sale of $1.92B in 2019 from its immunology segment with its only approved drug, Cimzia indicated for psoriatic arthritis (PsA). In Jul’19, Cimzia was approved by China’s NMPA.

Immunology Segment Revenue: $2.53B

Founded Year: 1973

Market Cap: ~$122.35B

Total Employees: ~100,000

Headquarter: Paris, France

Stock Exchange: EPA

Sanofi is a global healthcare leader in vaccines providing healthcare solutions in 170+ countries around the world. Sanofi is ranked third in the global market and first in EU and Latin America. Sanofi has four drugs in its immunology portfolio including one approved drug Kevzara, developed in partnership with Regeneron. In Dec’19, Sanofi presented the positive result from its pivoted phase 3 study of sutimlimab for cold agglutinin disease. Additionally, Sanofi restructured its agreement with Regeneron to obtain worldwide rights for Kevzara.

Immunology Segment Revenue: $2.97B

Founded Year: 1887

Market Cap: ~$135.30B

Total Employees: ~30,000

Headquarter: New York, United States

Stock Exchange: NYSE

Bristol-Myers Squibb is an American pharmaceutical company focused on Oncology, Cardiovascular, Immuno-Science, and Fibrosis. BMS has two approved drugs Orencia and Nulojix. BMS’ Orencia is a protein indicated to treat adult rheumatoid arthritis, juvenile idiopathic arthritis, and adult psoriatic arthritis has generated the highest revenue of $2.97B in 2019. The acquisition of Celgene in 2019, has boosted up BMS’ Immunology pipeline.

Immunology Segment Revenue: $3.66B

Founded Year: 1925

Market Cap: ~$52.60B

Total Employees: ~49,578

Headquarter: Osaka, Japan

Stock Exchange: TYO

Takeda is a global biopharma company focused on Oncology, Gastroenterology (GI), Neuroscience, Immunology, and Rare Diseases. With three approved drugs including Immunoglobulin, Albumin, and Entyvio, Takeda has generated a $3.66B sale in 2019. In Apr’19, EMA accepted the application for a subcutaneous formulation of Entyvio in Crohn’s disease, and in Oct 2019, Takeda acquired CNP-101 from COUR Pharmaceuticals. In Feb’20, Takeda acquired PvP Biologics to strengthen its immunology pipeline. Additionally, Takeda got approval for Entyvio from China’s NMPA for Crohn’s disease in Mar 2020.

Immunology Segment Revenue: $4.22B

Founded Year: 1996

Market Cap: ~$205.93B

Total Employees: ~109,000

Headquarter: Basel, Switzerland

Stock Exchange: SIX Swiss Exchange, NYSE

Novartis is a multinational group of companies specializing in research, development, manufacturing, and marketing with a broad range of healthcare solutions including generic and ophthalmic therapies. The company is focused on Immunology, Hepatology, Dermatology, Oncology, Neurology, and Ophthalmology. Novartis has the uppermost number of immunology drugs with eight approved products including ACZ885/Ilaris, AIN457/Cosentyx, Myfortic (Renal transplant), Neoral, Simulect, and Zortress. Novartis’ Cosentyx (secukinumab) used to treat Psoriasis, ankylosing spondylitis and psoriatic arthritis have generated global sales of $3.55B in 2019. In Apr’19 Novartis acquired IFM Tre to enhance its immunologic portfolio with its NLRP3 inhibitors for $1.5B.

Immunology Segment Revenue: $4.73B

Founded Year: 1849

Market Cap: ~$206.05B

Total Employees: ~83,000

Headquarter: New York, United States

Stock Exchange: NYSE

Pfizer is a research-based, global biopharmaceutical company having a vast portfolio including Oncology, Medicines, vaccines, and other health care products for the prevention & treatment of untreated diseases. With 3 approved drugs including Xeljanz, Enbrel (outside the US and Canada), and Inflectra (Biosimilar), Pfizer has generated $4.73B sale from its immunology portfolio indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, Behcet’s disease, and ulcerative colitis. Pfizer’s Xeljanz has generated revenue of $2.24B in 2019. In Jan’2019, CytoReason signed a research partnership with Pfizer to develop drugs using CytoReason’s cell-centered models of the immune system.

Immunology Segment Revenue: $5.39B

Founded Year: 1980

Market Cap: ~$134.11B

Total Employees: ~23,400

Headquarter: California, United States

Stock Exchange: NASDAQ

Amgen is one of the leading biotechnology company developing novel therapies focused on cardiology, oncology, neurology, nephrology, and inflammatory diseases. Amgen has generated a total sale of $5.39B in 2019 with its drugs Otezla, Avsola, Enbrel, Nplate, and Prolia. Amgen’s Otezla used to treat certain types of psoriasis and psoriatic arthritis has generated sales of $1.6B.

Immunology Segment Revenue: $8.79B

Founded Year: 1896

Market Cap: ~ $281.59B

Total Employees: ~98,000

Headquarter: Basel, Switzerland

Stock Exchange: SWX

Roche Holding AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. The immunology department focus on rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis including severe persistent allergic asthma (AA), chronic idiopathic urticaria (CIU), and idiopathic pulmonary fibrosis (IPF) with 3 approved drugs including Actemra, CellCept and Mabthera and has generated the sale of $8.97B in 2019. In Dec’2019, Roche signed an exclusive global option and license agreement with Rheos Medicines to develop and commercialize therapies for immune metabolism.

Immunology Segment Revenue: $13.95B

Founded Year: 1887

Market Cap: ~$378.94B

Total Employees: ~132,100

Headquarter: New Jersey, United States

Stock Exchange: NYSE

Johnson & Johnson (J&J) is an American multinational healthcare company focused on the development and commercialization of pharmaceutical, medical device, and consumer packaged products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. J&J has generated $13.95B from its Immunology portfolio with 5 approved products including Remicade, Simponi, Stelara, Tremfya, Simponi Aria. Remicade was jointly marketed by J&J and Merck and has generated a revenue of $4.38B in 2019. In Nov 2019, J&J’s Tremfya meets the primary endpoint in the phase 3 study for Psoriatic Arthritis. Additionally, J&J submit two applications with the USFDA for Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis. FDA approved Tremfya for Psoriatic Arthritis and Simponi Aria for polyarticular juvenile idiopathic arthritis and active psoriatic arthritis for patients 2 years of age and older in Jul 2020.

Immunology Segment Revenue: $19.57B

Founded Year: 2012

Market Cap: ~$146.29B

Total Employees: ~30,000

Headquarter: Illinois, United States

Stock Exchange: NYSE

AbbVie is a global, research and development-based biopharmaceutical company focused on developing innovative advanced therapies. The company is focused on developing products in immunology, oncology, virology, and neuroscience, dermatology. AbbVie has generated the sale of $19.57B in 2019 from its immunological segment with 3 approved drugs including RINVOQ, SKYRIZI, HUMIRA. AbbVie’s blockbuster drug HUMIRA recorded a revenue of $19.16B. In Apr’2019, AbbVie received EMA approval of SKYRIZI for Plaque Psoriasis. Its RA drug RINVOQ received FDA approval in Aug 2019 and EMA approval in Dec 2019. Additionally, RINVOQ achieved positive results in primary and key secondary endpoints for Psoriatic Arthritis and subsequently submitted the regulatory applications with the FDA and EMA.

Related Post: Top 20 Immunology Companies Based on 2018 Immunology Segment Revenue

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Adult data back Merck’s challenger to Pfizer’s blockbuster Prevnar 13

Merck & Co has built more momentum behind its attempt to depose Pfizer’s blockbuster pneumococcal conjugate vaccine Prevnar 13, with two new phase 3 trials backing its rival shot V114.

The two trials are both in adult subjects, a group that has been driving growth of Prevnar 13 in the last few years, and showed that V114 stimulated immune responses to all 15 pneumococcal serotypes included in the vaccine.

In the PNEU-PATH and PNEU-DAY studies, dosing with V114 was followed a year later by a shot of Merck’s older polysaccharide-based Pneumovax 23 vaccine, and showed that the combination was protective in the over-50 and under-50 adult age groups, respectively.

US-based Merck already has phase 3 data in hand backing the safety and efficacy of V114 in children as well as non-inferiority to Prevnar 13 for the serotypes the two vaccines share. It reiterated its plans to file for approval of the vaccine before the end of the year in the US.

Prevnar 13 – which as its name suggests covers 13 serotypes – is the world’s top-selling vaccine, adding almost $6 billion to Pfizer’s top-line last year thanks to its dominant position in the paediatric pneumococcal shot market.

Added to that, it’s not due to lose patent protection until 2026, when analysts predict it could make more than $7 billion, although it’s worth noting that growth has been pegged back so far in 2020 as a result of the pandemic lockdowns.

Merck is hoping to trump its rival with 15-valent V114, as it provides protection against two serotypes – 22F and 33F – that aren’t included in Pfizer’s product. It also provides an opportunity to expand its position in the adult pneumococcal disease market, where Pneumovax 23 is still widely used.

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Merck’s chief medical officer Roy Baynes.

“These data provide important information about the potential for V114 followed by Pneumovax 23 [which is] included in more than 90% of age-based adult pneumococcal immunization programmes globally,” he added.

Pfizer isn’t resting on its laurels however, and is preparing to defend its Prevnar franchise, reporting positive clinical results with a 20-serotype follow-up – called PF-06482077 or 20vPnC – that it also thinks could be ready for filing before the end of the year.

As a backup it has also been developing a 7-serotype shot that would provide the same breadth of cover as 20vPnC when combined with Prevnar 13.

Pneumococcal disease is caused by Streptococcus pneumoniae, and includes non-invasive illnesses like pneumonia, sinusitis and middle ear infections, as well as invasive diseases like meningitis.

It can be particularly problematic in young children under two and adults aged over 65, as well as people with compromised immune systems.

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Pfizer ‘ready to roll’ if BioNTech COVID-19 shot is approved

Pfizer now has hundreds of thousands of doses of BioNTech’s COVID-19 vaccine coming off the production line at a facility in Belgium, ready for delivery if it clears phase 3 testing.

The output of the plant in Puurs should allow the partners to have 100 million doses of BNT162b2 ready for delivery by the end of the year, according to a Mail on Sunday report, which claims 40 million of those doses are destined for the UK.

As two doses of the mRNA-based shot are required to stimulate an immune response against the coronavirus, that would be enough to vaccinate 20 million people.

The COVID-19 shot started a rolling review at the European Medicines Agency (EMA) earlier this month – which involves the agency evaluating data as they become available rather than in one block – and that means approval could come shortly after the 44,000-patient trial readout which is due by the end of this month.

Video footage of vaccine vials coming off the production line have generated excitement and puts Pfizer and BioNTech in pole position to get the first COVID-19 shot approved.

Pfizer is predicting a longer timeline in the US than Europe however, saying it won’t be able to file for emergency use authorisation in the US until the third week of November – assuming trials go as planned of course.

While top-line data on efficacy could be ready this month, at least half the recipients of the shot in the trial will have to be followed for safety for two months after the second dose, and that will set back the EUA filing.

That timescale dashes any chance of a feelgood coronavirus vaccine story for Donald Trump as he campaigns for a second term as US President. Pfizer and BioNTech were among a group of nine COVID-19 vaccine developers who pledged not to launch before thorough tests are completed.

The federal government agreed an initial order of 100 million doses of BNT162b2 in July, with an option on up to 500 million, and Pfizer and BioNTech reckon they have the capacity to make 1.3 billion doses next year.

The Pfizer update comes as the UK’s deputy chief medical officer Prof Jonathan Van-Tam suggested that Oxford University and AstraZeneca’s AZD1222 shot – based on a different technology – could be available in the UK “soon after Christmas”.

That timeframe would allow vaccination of elderly and vulnerable people as well as key workers to begin in the New Year, according to an article in the Sunday Times. The comments were made at a joint Commons and Lords national security strategy committee meeting.

Chief scientific officer Sir Patrick Vallance told the panel that a vaccine is unlikely to be widely available until next spring, and reiterated his view that the SARS-CoV-2 coronavirus will become endemic. However, he suggested it’s level of threat could be reduced to that of seasonal flu if effective vaccines are available.

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UK government signs contract for COVID-19 challenge trial

The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment with coronavirus to test whether a vaccine is effective.

Contract research organisation (CRO) hVIVO, a subsidiary of Open Orphan, has signed the contract with the UK government to develop the trial model.

This will involve manufacture of the challenge virus and the first-in-human characterisation study for the virus.

The characterisation study, which is expected to be completed in May 2021, still needs ethical and regulatory approval.

It is designed to assess the minimum dose of the virus required, before moving on to the next stage when a vaccine will be administered.

The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital’s specialist research unit in London, under the scrutiny of highly trained scientists and medics.

hVIVO will also be expanding its clinical operations in London to conduct the trial.

It’s not clear which vaccine will be involved in the study – there are several in the last stages of clinical development and the UK government has orders for candidates from AstraZeneca, Pfizer/BioNTech, Novavax, Valneva, Sanofi/GSK and Johnson & Johnson.

No financial details of the contract with hVIVO were disclosed.

Challenge trials are controversial because of the risks involved with infecting patients with a potentially lethal virus, although with the SARS-CoV-2 coronavirus these could be managed as most people develop mild symptoms and those at high risk of a serious infection are relatively easy to identify.

hVIVO is already known for its challenge studies in other infectious diseases, which are conducted a 24-bedroom quarantine clinic with onsite virology, providing individually isolated rooms and connected to a specialist laboratory facility.

Open Orphan, which comprises of two commercial CRO services business hVIVO and Venn Life Sciences, has been working on several coronavirus challenge study models and expects to be busy over the next few months helping several pharma and biotech companies test their vaccines.

Anyone interested in being contacted and provided with details about future COVID-19 human challenge study research may leave their contact details at www.UKCovidChallenge.com.

The World Health Organization has been keeping tabs on the development of vaccines since the start of the pandemic and says there are now 44 in clinical development.

The three most advanced are being developed in China where the pandemic is thought to have originated, followed by a candidate from Oxford University and AstraZeneca in the UK.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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Pfizer to wait until after election to file COVID-19 vaccine in US

Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety data to become available.

The vaccine is being developed by Pfizer and development partner BioNTech and will wait until late November to make its application with the FDA.

In a letter published on its website Pfizer may have the data to say whether the vaccine is effective this month, based on the findings of the ongoing 40,000 person clinical trial.

But CEO Alfred Bourla cautioned that the safety data will only be ready in the third week of November.

There have already been two safety scares in COVID-19 vaccine trials – Johnson & Johnson earlier this week put its phase 3 trial on hold because of an undisclosed illness in a patient.

A US trial of AstraZeneca’s shot is also on hold after a similar incident, although studies in other parts of the world have restarted.

As vaccines will be given to healthy individuals, regulators have far less tolerance for adverse events.

There are further concerns that political interference during the election build-up could undermine the credibility of a mass vaccination programme.

Bourla said: “So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US. soon after the safety milestone is achieved in the third week of November.”

Despite the concerns of scientists president Donald Trump has said that there would be a vaccine available before the election on 3rd November and is hoping that approval could be the “October Surprise” that could boost his popularity ahead of the vote.

Rival Moderna has said it could apply for an Emergency Use Authorization for its rival vaccine as soon as November.

The European Medicines Agency has already started a rolling review of the Pfizer/BioNTech and AstraZeneca vaccines.

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PharmaShots Weekly Snapshot (Oct 12-16, 2020)

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec

Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

Published: Oct 15, 2020 | Tags: Clinical, Trial, Galapagos, GLPG1972/S201086, Knee Osteoarthritis, Patients, P-II, Report, results, ROCCELLA, Servier

Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

Published: Oct 15, 2020 | Tags: advance, Against, Clinical, Study, COVID-19, MRT5500, Sanofi, Translate, Bio

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

Published: Oct 15, 2020 | Tags: Chugai, Drug, First, Japan, MHLW, NDA, Oral, Report, Risdiplam, Spinal Muscular Atrophy

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

Published: Oct 15, 2020 | Tags: Adult, approval, KEYTRUDA, Merck, patients, pembrolizumab, receives, Relapsed Refractory cHL, US, FDA

Eli Lily to Acquire Disarm Therapeutics for ~$1.36B

Published: Oct 15, 2020 | Tags: ~$1.36B, Acquire, Disarm, Therapeutics, Eli Lily

Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to Safety Concerns

Published: Oct 14, 2020 | Tags: ACTIV-3, Clinical, Decision, Due, Eli Lilly, Enrollment, NIAID, Pause, Trial

Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil

Published: Oct 14, 2020 | Tags: Abivertinib Maleate, ANVISA, approval, COVID-19, Mild, P-II, patients, Proceed, receives, Severe, Sorrento, STI-5656, Trial

Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

Published: Oct 14, 2020 | Tags: 1EP, Aliqopa, Bayer, copanlisib, Meets, patients, reports, results, Rituximab

Takeda Collaborates with Accenture and AWS to Transform into a Cloud-Based Company

Published: Oct 13, 2020 | Tags: Accenture, AWS, Cloud-Based Company, Collaborates, Takeda, Transform

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

Published: Oct 15, 2020 | Tags: approval, atoltivimab, Ebolavirus, First, Inmazeb, maftivimab, odesivimab, receives, Regeneron, Treatment, US, FDA

Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B

Published: Oct 14, 2020 | Tags: ~$1.8B, AVV, Gene, Therapy, Develop, Dyno, License, Agreement, Roche, Signs

Boehringer Ingelheim Presents Results of Gilotrif (afatinib) for NSCLC at IASLC NACLC 2020

Published: Oct 14, 2020 | Tags: 2020, Boehringer Ingelheim, Gilotrif, IASLC, NACLC, Report, Result

Moderna Initiates Rolling Submission to Health Canada for mRNA-1273 Against COVID-19  

Published: Oct 14, 2020 | Tags: COVID-19, Health Canada, Moderna, mRNA Vaccine, mRNA-1273, Rolling Submission

Prestige’s PBP1510 Receives EMA’s Positive Opinion on Orphan Designation for Pancreatic Cancer

Published: Oct 14, 2020 | Tags: Designation, EMA, Opinion, Orphan, Pancreatic cancer, PBP1510, Positive, Prestige, receives

Celltrion Launch P-III Post-Exposure Prophylaxis Clinical Trial of CT-P59 for COVID-19

Published: Oct 14, 2020 | Tags: Anti, Candidate, Celltrion, Clinical Trial, COVID-19, CT-P59, Launch, mAb, P-III, Treatment

Linnaeus Reports First Patients Dosing with LNS8801 + Keytruda (pembrolizumab) in P-I/II Study for Advanced Cancer

Published: Oct 14,2020 | Tags: Advanced Cancer, First Patients Dosing, KEYTRUDA, Linnaeus, LNS8801, pembrolizumab, reports</