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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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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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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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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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.

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

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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.

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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.

 

 

 

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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.

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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.

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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.

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

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Moderna and BioNTech – who are they?

Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. Just who are these companies and who is behind them, asks Richard Staines.

A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings.

But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.

Compared with many of the established names in pharma these companies are young upstarts but they have managed to achieve what other big names in the industry have failed to do and harness the power of mRNA to make medicine.

Their technology is based on synthetic messenger RNA – short for ribose nucleic acid – which is a short transcript of a longer DNA code.

As it’s just a messenger molecule, it does not affect the body’s own genetic code when it is injected as a vaccine – but what it does do is instruct cells to code for copies of a certain protein.

In this case that is the “spike” protein seen on the surface of the coronavirus that it uses to invade host cells.

The body produces antibodies against the protein, which neutralise the virus in the event of an infection.

It’s a revolutionary approach that allowed the vaccine to be made within a few days of the SARS-CoV-2 genetic code becoming available – what’s taken months are the rigorous clinical trials that proved the vaccines were safe and effective.

There has been considerable anxiety over whether using such an untried technology would be the best approach against COVID-19.

What the companies have now proved is that the technology can be used to make safe and effective vaccines in record time.

The companies are based on opposite sides of the Atlantic – Moderna was founded in Massachusetts in 2010 under the name ModeRNA Therapeutics by a team of investors two years after BioNTech began operating from a small lab in Mainz, Germany.

But both drew on the mRNA technology developed by Katalin Kariko from the University of Pennsylvania and her collaborator Drew Weissman, an immunologist from Boston University.

Together the pair had managed to find a way to get the human body to accept strands of mRNA without an immune reaction, by tinkering with the chemical make-up of the molecule.

It was a landmark discovery that meant a technology once derided as being a pipe dream could have applications in the real world as a medicinal therapy.

Moderna’s founders were led by Derrick Rossi, a post doctorate fellow from Stanford University who championed the technology to a team from Flagship Ventures, a Massachusetts firm founded and run by Noubar Afeyan.

CEO Stephane Bancel was hired the following year from France’s bioMerieux and Moderna went on to raise more than $2.6 billion in a series of private funding rounds, while fiercely guarding any details about the technology it was developing.

This changed in 2018 when Moderna went public with what was at that time the largest IPO in biotech history.

The launch raised $500m from investors using what is arguably the slickest stock market ticker out there – MRNA.

Its portfolio of products was broad – including a drug being developed with AstraZeneca for cardiovascular diseases, a cancer immunotherapy and a potential Zika vaccine.

“I was intrigued by the personalities of the founders. They are very good doctors, scientists and entrepreneurs. Whatever they were beginning they did it with the end in mind.”

While Moderna blazed its investment trail and tried to find ways to make sure its mRNA vaccines did not produce dangerous immune reactions, a small biotech called BioNTech had licensed in the technology from Kariko and Weissman.

Run by husband-and-wife team Ugur Sahin and his wife Ozlem Tureci, BioNTech wanted to use the technology to create individualised cancer therapies.

Matthias Kromayer, a general partner at the German investment fund MIG that helped found BioNTech in 2008, said he first met the pair 15 years ago and was immediately intrigued.

He told pharmaphorum: “They are very good doctors, scientists and entrepreneurs. Whatever they were beginning they did it with the end in mind.”

The company began to strike several deals with big pharma companies to develop cancer drugs and in 2013 hired Kariko, who had spent years working on mRNA at Penn, to oversee the mRNA work as senior vice president.

Fast-forward to the beginning of 2020 and the companies realised that they would have to quickly change their research priorities to vaccine development as the coronavirus pandemic began to emerge in China.

Kromayer said the risks and opportunities to take on the coronavirus vaccine challenge were huge for BioNTech, which only went public on the Nasdaq at the end of 2019.

He said: “It was a risk – if (the vaccine) had failed it would have shed negative light on mRNA tech. But it was a once in a lifetime opportunity.”

But according to Kromayer the BioNTech team were confident that mRNA was the solution to the coronavirus problem, as mRNA sequences can be generated in such a short amount of time.

“You can manufacture mRNA vaccine overnight and still it is stable,” said Kromayer.

The rest is history – Pfizer stepped in and licensed the technology, choosing the most promising of four potential mRNA vaccines from BioNTech.

Both Moderna and Pfizer’s shots aced the quickly convened clinical trials and became the first vaccines to make it to market less than a year after the pandemic began.

Thanks to the innovation there are hopes that peoples’ lives may return to normal as 2021 progresses but according to Kromayer this is just the tip of the iceberg for mRNA therapeutics.

The founders of both Moderna and BioNTech realised early on that this is far more than just a vaccine and could be used to tackle diseases that have proved impossible to tackle with the previous generations of medical technology.

Rossi, who left Moderna in 2014 had initially thought it could be used to reprogramme cells to act like stem cells but realised its potential after a bruising encounter with Robert Langer, the legendary MIT scientist and entrepreneur.

According to Kromayer potential uses include pre-emptive vaccines for diseases such as Parkinson’s as well as to create personalised cancer therapies.

Kromayer concluded: “The message is that mRNA based medicines are not just here to serve as vaccines it is much, much, more. This will revolutionise medicine over the next 10-15 years in areas we do not even imagine.”

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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.

PharmaShots Weekly Snapshots (Dec 14-18, 2020)

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada

Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz

Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases

Published: Dec 17, 2020 | Tags: Adult, Amgen, approval, Biosimilar, CLL, GPA, MPA, NHL, patients, receives, RIABNI, Rituxan, Rituximab, rituximab-arrx, Us FDA

NOWDiagnostics Receives CE Mark for its ADEXUSDx COVID-19 Antibody Fingerstick Test

Published: Dec 17, 2020 | Tags: ADEXUSDx COVID-19, Antibody Fingerstick Test, COVID-19, Launches, NOWDiagnostics

GSK’s Benlysta (belimumab) Receives the US FDA’s Approval as the First Therapy for Active Lupus Nephritis (LN)

Published: Dec 17, 2020 | Tags: (belimumab), Active, Benlysta, GSK, Lupus Nephritis (LN), Recieves, US, US FDA’s Approval

GSK Signs an Exclusive License Agreement with Surface Oncology to Develop and Commercialize SRF813

Published: Dec 17, 2020 | Tags: Commercialize, Develop, Exclusive License Agreement, GSK, Signs, SRF813, Surface Oncology

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Published: Dec 17, 2020 | Tags: Advisory, Against, Committee, COVID-19, EUA, Moderna, receives, Supporting, US, Us FDA, vaccine, Vote

Novartis to Acquire Cadent Therapeutics for ~$770M

Published: Dec 17, 2020 | Tags: $770M, Acquire, Cadent, Novartis, therapeutics

Kite’s Tecartus (KTE-X19) Receives EC’s Conditional Marketing Authorization for R/R Mantle Cell Lymphoma

Published: Dec 16, 2020 | Tags: (KTE-X19), EC’s Conditional Marketing Authorization, Europe, Kite, receives, Relapsed or Refractory Mantle Cell Lymphoma, Tecartus, ZUMA-2 Study

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

Published: Dec 16, 2020 | Tags: Advanced, Amgen, KRAS G12C, Metastatic, Mutation, NDA, NSCLC, reports, Sotorasib, Submission, Us FDA

Novartis’s Zolgensma Receives Health Canada Approval as the One-Time Gene Therapy for Pediatric Patients with SMA

Published: Dec 16, 2020 | Tags: approval, Health Canada, Novartis, One-Time Gene Therapy, receives, Spinal Muscular Atrophy (SMA), Zolgensma

Novo Nordisk to Initiate a P-lll Study of Semaglutide to Treat Alzheimer Disease

Published: Dec 16, 2020 | Tags:  Alzheimer Disease, Novo Nordisk, P-lll Development, Semaglutide, Start

Novartis’s Entresto Receives the US FDA’s Advisory Committee Recommendation to Treat Patients with HFpEF

Published: Dec 15, 2020 | Tags: Advisory, Committee, Entresto, HFpEF, Novartis, patients, Positive, receives, Recommendation, Treat, USFDA

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

Published: Dec 15, 2020 | Tags: Abbott, antibody, Blood, CE Mark, COVID-19, IgG, Quantitative, receives, Test

Ellume’s COVID-19 Home Test Receives the US FDA’s EUA as First Over-the-Counter Diagnostic Test

Published: Dec 15, 2020 | Tags: Antigen, COVID-19, Ellume, EUA, receives, Test, Us FDA

Bone Health’s OsteoBoost Vibration Belt Receives the US FDA’s Breakthrough Device Designation for Osteoporosis

Published: Dec 15, 2020 | Tags: Belt, Bone Health Technologies, Breakthrough, Designation, Device, OsteoBoost, receives, USFDA, Vibration

Takeda Reports the US FDA’s Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis

Published: Dec 15, 2020 | Tags: (budesonide oral suspension), Eosinophilic Esophagitis (EoE), NDA, reports, TAK-721, Takeda, US FDA’s Acceptance

Athenex’s Klisyri (tirbanibulin) Receives the US FDA’s Approval for Actinic Keratosis on the Face or Scalp

Published: Dec 15, 2020 | Tags: (tirbanibulin), Actinic Keratosis, Athenex’s, Face, Klisyri, receives, Scalp, US FDA’s Approval

Gilead Amends Agreement with Galapagos for Development and Commercialization of Jyseleca (filgotinib)

Published: Dec 15, 2020 | Tags: Agreement, Commercialization, Development, Filgotinib, Galapagos, Gilead, Jyseleca, Signs

Lilly to Acquire Prevail Therapeutics for ~$1.04B

Published: Dec 15, 2020 | Tags: ~$1.04B, Acquire, Lilly, Prevail Therapeutics

EMA’s CHMP Recommends Four-Week Dosing Option for AstraZeneca’s Imfinzi to Treat Unresectable NSCLC

Published: Dec 15, 2020 | Tags: approval, AstraZeneca, CHMP, EU, Imfinzi, NSCLC, Recommended, Unresectable

CureVac Commences P-llb/lll Trial of CVnCoV for COVID-19

Published: Dec 14, 2020 | Tags: Commences, COVID-19, CureVac, CVnCoV, P-llb/lll Trial

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

Published: Dec 15, 2020 | Tags: Advanced, breast, Cancer, Cobas, Launch, Metastatic, Mutation, patients, PIK3CA, Roche, Test

Samsung Bioepis Initiates P-Ill Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Dec 14, 2020 | Tags: (Denosumab), Initiates, P-Ill Study, Prolia, Proposed Biosimilar, Samsung Bioepis, SB16

Genentech Signs a Worldwide License Agreement with Relay Therapeutics to Develop and Commercialize RLY-1971

Published: Dec 14, 2020 | Tags: Agreement, Commercialization, Develop, Genentech, Relay Therapeutics, RLY-1971, Signs, Worldwide License

Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis

Published: Dec 14, 2020 | Tags: approval, Genentech, Multiple Sclerosis, ocrelizumab, Ocrevus, Primary, Progressive, receives, Relapsing, Us FDA

Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for Approval to Treat HER2 Positive Metastatic Breast Cancer

Published: Dec 11, 2020 | Tags: approval, AstraZeneca, breast, Cancer, CHMP, Daiichi Sankyo, Deruxtecan, EU, HER2, Metastatic, Positive, Recommended, trastuzumab

Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19

Published: Dec 14, 2020 | Tags: COVID-19, Novartis, P-lll, reports, results, RUXCOVID Study, ruxolitinib

AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment of COPD

Published: Dec 14, 2020 | Tags: AstraZeneca’s, China, EU’s Approval, Japan, moderate to severe chronic obstructive pulmonary disease (COPD), receives, Trixeo Aerosphere, US

Alvotech and Fuji Pharma Extends Agreement for the Commercialization of Four Biosimilars in Japan

Published: Dec 10, 2020 | Tags: Agreement, Alvotech, Biosimilar, Commercialization, Extends, Four, Fuji Pharma, Japan, Medicines

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

Date: Dec 11, 2020 | Tags: BioNTech, BLA, BNT162b2, COVID-19, EUA, files, Pfizer, Prevent, receives, Us FDA

AstraZeneca to Acquire Alexion for $39B

Published: Dec 12, 2020 | Tags: $39B, Acquires, Alexion, AstraZeneca

Related News: PharmaShots Weekly Snapshots (Dec 7-11, 2020)

The post PharmaShots Weekly Snapshots (Dec 14-18, 2020) first appeared on PharmaShots.

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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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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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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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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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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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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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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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.

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.

The post Social media erupts as anti-vaxxers respond to COVID-19 vaccine approval appeared first on .

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

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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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PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

Merck Collaborates with Siemens for the Digitalization of Production

Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign

CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test

Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test

PostEra Collaborates with NeuroLucent to Identify Therapies for Alzheimer’s Disease

Published: Nov 25, 2020 | Tags: Agreement, Alzheimer Disease, Collaborative, Develop, NeuroLucent, Novel, PostEra, Sign, Treatment

BASE10 Collaborates with DNA Link to Support Authorization of COVID-19 IgG Antibody Test at the Point of Care

Published: Nov 26, 2020 | Tags: BASE10, Collaborates, DNA, Link, Support, Authorization, COVID-19, IgG Antibody, Test, Point, Care

Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda

Published: Nov 26, 2020 | Tags: Agreement, Alliance, Egle, First, Identifies, Novel, Regulatory, Research, T-cell, Takeda, Targets, therapeutics

Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to Treat Advanced NSCLC with METex14 Skipping Alterations

Published: Nov 26, 2020 | Tags: Advanced NSCLCs, EMA’s Validation, MAA, Merck, reports, Tepotinib, Treat

Y-mAbs’ Danyelza (naxitamab-gqgk) Receives the US FDA’s Approval for Neuroblastoma

Published: Nov 25, 2020 | Tags: (naxitamab-gqgk), approval, Danyelza, Neuroblastoma, receives, US FDA’s, Y-mAbs Therapeutics

CorticoMetrics’s THINQ Receives the US FDA’s 510(k) Clearance for MRI Brain Volumetric Reporting

Published: Nov 24, 2020 | Tags: 510(k), Brain, Clearance, CorticoMetrics, MRI, receives, Reporting, THINQ, Us FDA, Volumetric

BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China

Published: Nov 25, 2020 | Tags: BioNTech, BNT162b2, China, Clinical Trial, Covid-19 Vaccine, Fosun Pharma, Lead mRNA, P-ll, Resumes

Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain

Published: Nov 24, 2020 | Tags: Irritable Bowel Syndrome, P-IIa, reports, results, Sciences, study, Treatment, Urovant, Vibegron

Bio-Thera Reports MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Published: Nov 25, 2020 | Tags: Avastin, BAT1706 Proposed Biosimilar, Bio-Thera Solutions, Cancer, EMA, Marketing Authorization Application, Submits

Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in Class Treatment for Active Psoriatic Arthritis

Published: Nov 25, 2020 | Tags: Active Psoriatic Arthritis (PsA), EC’s Approval, First in Class, guselkumab, Janssen’s, receives, Treatment, Tremfya

Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD

Published: Nov 24, 2020 | Tags: Associated, Bausch Health, Disease, Dry Eye, Initiates, Investigational, MGD, NOV03, P-III, Second, study, Treatment

Evotec Collaborates with Rappta Therapeutics to Focus on Oncology Target

Published: Nov 24, 2020 | Tags: Agreement, Development, Discovery, Evotec, Focused, Oncology, Rappta, Signs, Target, therapeutics

Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19

Published: Nov 24, 2020 | Tags: COVID-19, Gamaleya Center, P-lll Study, RDIF, reports, results, Second Interim Analysis, Sputnik V

Alvotech and Alvotech & CCHT Sign an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

Published: Nov 24, 2020 | Tags: Alvotech, CCHT, China, Eight Biosimilar Medicines, Exclusive Commercialization Agreement, Sign, Yangtze River

Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

Published: Nov 24, 2020 | Tags: Adult, Alnylam, approval, Hyperoxaluria, Lumasiran, OXLUMO, patients, Pediatric, Primary, receives, Treatment, Type 1, Us FDA

BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma

Published: Nov 24, 2020 | Tags: 2L Treatment, Bristol Myers Squibb, EC’s Approval, Metastatic Esophageal Squamous Cell Carcinoma (ESCC), Nivolumab, Opdivo, receives, Unresectable Advanced

Selvita to Acquire Fidelta from Galapagos for ~$37M

Published: Nov 23, 2020 | Tags: $37.08M, Acquire, Fidelta, Galapagos, Selvita

Targovax Reports Results of ONCOS-102 in P-l/ll Study as 1L and 2L Treatment for Malignant Pleural Mesothelioma

Published: Nov 24, 2020 | Tags: (SoC), 1L and 2L Treatment, Malignant Pleural Mesothelioma (MPM), ONCOS-102, P-l/ll Study, reports, results, SITC Annual Meeting, Standard of Care, Targovax

Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza

 Published: Nov 24, 2020 | Tags: approval, baloxavir marboxil, Contact, Following, Infected,  Influenza, Person, Prevention, receives, Roche, Us FDA, Xofluza

Baxter’s Homechoice Claria APD System Receives the US FDA’s 510 (k) Clearance for Kidney Failure

Published: Nov 23, 2020 | Tags: Baxter’s, Claria Automated Peritoneal Dialysis (APD) System, Clearance, Homechoice, Kidney Failure, receives, US, US FDA’s 510 (k)

Schrödinger Signs a $2.7B Agreement with BMS to Develop and Commercialize Therapies in Multiple Disease Areas

Published: Nov 23, 2020 | Tags: Agreement, Areas, BMS, Commercialize, Develop, Discover, Disease, Multiple, Schrödinger, Signs, therapeutics

Merck to Acquire OncoImmune for $425M

Published: Nov 23, 2020 | Tags: Acquire, CD24Fc program, Merck, OncoImmune

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

Published: Nov 23, 2020 | Tags: AstraZeneca, AZD1222, COV002, COV003, COVID-19, P-II/III, P-III, Positive, Preventing, reports, results, Trial, vaccine

Eli Lilly Signs an Exclusive Agreement with Precision BioSciences on Genome Editing Research

Published: Nov 20, 2020 | Tags: Develop of Potential, Genetic Disorders, License Agreement, Lilly, Precision, Research, Research Collaboration, Signs, Vivo Therapies

Eiger’s Zokinvy (lonafarnib) Receives the US FDA’s Approval for Treatment of Progeria and Processing-Deficient PL

Published: Nov 20, 2020 | Tags: approval, Deficient, Eiger, lonafarnib, PL, Processing, Progeria, receives, Treatment, Us FDA, Zokinvy

Innovent Reports Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Published: Nov 22, 2020 | Tags: 1L treatment, Advanced Hepatocellular Carcinoma (HCC), Byvasda, ESMO ASIA Virtual Congress 2020, Innovent, ORIENT-32 Study, P-lll, reports, results, Tyvyt

Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

Published: Nov 20, 2020 | Tags: Authorization, Bamlanivimab, canada, COVID-19, health, Interim, Lilly, LY-CoV555, receives, Treatment

Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19

Published: Nov 21, 2020 | Tags: Casirivimab, COVID-19, EUA, Imdevimab, patients, receives, Regeneron, US FDA’s

Related Post: PharmaShots Weekly Snapshot (Nov 16-20, 2020)

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BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China

Shots:

  • The companies initiated the P-II study of their COVID-19 vaccine in China. The trial will generate data to support the BLA filing for approval of the vaccine in China
  • The study will be conducted by Jiangsu Provincial Center for Disease Control and Prevention. The study will commence with the recruitment of 960 patients aged b/w 18-85yrs.
  • In an ongoing P-III study, it met all 1EPs with an 95% efficacy rate in preventing symptomatic COVID-19 infection. The data supports the submission of an EUA to the US FDA on Nov 20, 2020

Click here ­to­ read full press release/ article | Ref: BioNTech | Image: World Pharma Day

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BioNTech, InstaDeep plan joint lab for AI research

BioNTech may be deeply ensconced in the latter stages of its bid to bring a COVID-19 vaccine to market, but it’s still pushing forward on other fronts, including a partnership with InstaDeep to deploy artificial intelligence and machine learning across its business.

The two companies have been working together in this area since 2019, but BioNTech has opted to double down on the alliance with a revised agreement focusing on new immunotherapies for cancer and infectious diseases.

The headline news in the new agreement is the formation of a joint AI Innovation Lab – split between InstaDeep’s headquarters in London in the UK and BioNTech’s site in Mainz Germany – that will focus on drug discovery and design, protein engineering, manufacturing and supply chain.

One of the main research areas for the new lab will be the development of new vaccines and biologic drugs for the treatment of cancer and prevention and treatment of infectious diseases, including COVID-19.

InstaDeep – which was founded in Tunisia – has built its business across a range of sectors, mainly helping small- and mid-sized companies to develop bespoke apps harnessing computer vision, predictive analytics, 3D imaging, augmented and virtual reality, and deep learning. It was recently nominated by CB Insights as one of the 100 most promising AI start-ups in the world

With BioNTech, the company will focus on three main areas. The duo will apply InstaDeep’s protein design platform – called DeepChain – to engineer new mRNA sequences against protein targets, and also collaborate on sifting through anonymised patient data to identify new drug targets and biomarkers.

They will also use AI and machine learning to find ways to make manufacturing and supply chain processes more efficient, tapping into technologies like robotics and autonomous decision-making algorithms.

“Pairing BioNTech’s deep knowledge of the human immune system and scientific data-driven development approach with our AI platform could transform the way we discover and develop new drug classes for patients all over the world,” said Karim Beguir, InstaDeep’s chief executive.

A recent study by Kearney revealed that 68% of global industry leaders in the healthcare sector see AI and advanced analytics as major value drivers.

All attention at the moment is on BioNTech’s Pfizer-partnered coronavirus vaccine BNT162b, but it has a packed pipeline of earlier-stage projects, including a Roche-partnered mRNA-based drug for melanoma in phase 2 and several other cancer therapies in phase 1.

“We see a significant opportunity at the intersection of AI and immunology by computational design of new precision immunotherapies,” said BioNTech chief executive Ugur Sahin. “This collaboration will expand our digital capabilities and optimise our operations across the value chain.”

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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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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

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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

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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.

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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

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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)

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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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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 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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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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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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BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

Shots:

  • The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process to facilitate the final MAA
  • BNT162b2 vaccinated participants showed a favorable breadth of epitopes recognized in T-cell responses specific to SARS-CoV-2 spike antigen & BNT162b2 demonstrated concurrent induction of high magnitude CD4+ & CD8+ T cell responses which are TH-1 dominant against RBD and remainder of full spike glycoprotein
  • BNT162b2 vaccine candidate (BioNTech’s proprietary mRNA technology and supported by Pfizer) encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S). It is currently being evaluated in an ongoing P-III study with ~37,000 participants enrolled and 28,000 having received their second vaccination at >120 clinical sites worldwide including the US, Brazil, South Africa, and Argentina

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: King’s College London

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Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University.

The announcement comes just days after the regulator said its CHMP scientific committee had begun to look at the first batch of data from AZ’s rival.

In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted.

It’s hoped that this will hasten the process, which would take more than a year in normal conditions.

Once the CHMP thinks there is enough data the company submits the complete filing, allowing the committee to reach a fast decision, which is passed on to the European Commission.

The CHMP begun its review of the vaccine, known as BNT162b2 based on preliminary results from pre-clinical and early clinical studies.

These studies suggest BNT162b2 triggers the production of neutralising antibodies and T-cells that target SARS-CoV-2, the coronavirus that causes COVID-19.

The vaccine is based on different technology from AZ’s rival: while AZ’s uses a weakened and genetically modified cold virus to prime the immune system, BNT162b2 is based on a string of RNA.

The RNA instructs the body to produce copies of the Spike protein found on the surface of the coronavirus, which produces an immune response and causes the body to neutralise the virus if it infects the body.

BNT162b2 is being tested in a global phase 3 study ongoing at more than 120 clinical sites worldwide including the US, Brazil, South Africa and Argentina.

To date, the trial has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination.

According to latest figures from the World Health Organization, there are 42 potential COVID-19 vaccines in clinical development.

It lists a candidate developed by China’s Sinovac as the most advanced, with AZ’s shot now fourth on the list after trials were temporarily halted because of a potential safety issue.

Pfizer’s is further back on the list, although there are suggestions that it could be approved in the US in time for the presidential elections on 3rd November.

US trials of AZ’s vaccine have not restarted while the FDA investigates the safety issue that caused the trials to be paused around a month ago.

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PharmaShots Weekly Snapshot (Aug 24 -28, 2020)

1. Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis

Published: Aug 27, 2020 | Tags:  Taysha Gene Therapies, TSHA-101, Receives, US, FDA, Orphan Drug Designation, Rare Pediatric Disease Designation, GM2 Gangliosidosis

2. Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

Published: Aug 28, 2020 | Tags:  Bayer, Reports, NDA, Submission, NMPA, Chronic Heart Failure, China, Vericiguat

3. Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug Designations for Idiopathic Pulmonary Fibrosis

Published: Aug 27, 2020 | Tags: Galecto, GB0139, Receives, US, FDA, EMA, Orphan Drug Designations, Idiopathic Pulmonary Fibrosis

4. Philips to Acquire Intact Vascular for $360M

Published: Aug 27, 2020 | Tags: Philips, Acquire, Intact Vascular, $360M

5. BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao

Published: Aug 27, 2020 | Tags: BioNTech, Fosun Pharma,  Supply, ~10M, Doses, COVID-19 Vaccine, Hong Kong, Macao

6. Amazon Enters into Fitness Space with the Launch of Halo Band and App

Published: Aug 27, 2020 | Tags: Amazon, Enters, Fitness Space, Launch, Halo Band

7. BeiGene Signs an Exclusive License Agreement with Singlomics for Neutralizing COVID-19 Antibodies

Published: Aug 27, 2020 | Tags: BeiGene, Signs, Exclusive, License Agreement, Singlomics, Neutralizing, COVID-19, Antibodies

8. Abbott’s BinaxNOW COVID-19 Ag Card Receives the US FDA’s EUA to Detect COVID-19

Published: Aug 27, 2020 | Tags: Abbott, BinaxNOW COVID-19 Ag Card, Receives, US, FDA, EUA, Detect, COVID-19

9. FDC Launches Two Variants of Favipiravir for COVID-19 in India

Published: Aug 26, 2020 | Tags:  FDC, Launches, Two Variants, Favipiravir, COVID-19, India

10. Celltrion Initiates P-I Study of CT-P59 Against COVID-19 in Korea

Published: Aug 26, 2020 | Tags:  Celltrion, Initiates, P-I, Study, CT-P59, COVID-19, Korea

11. GSK’s Blenrep (belantamab mafodotin) Receives EC’s Approval for R/R Multiple Myeloma

Published: Aug 26, 2020 | Tags:  GSK, Blenrep, (belantamab mafodotin), Receives, EC’s, Approval, R/R, Multiple Myeloma

12. Lupin and Mylan Launch Nepexto (biosimilar, etanercept) in Germany

Published: Aug 26, 2020 | Tags: Fitbit, Report, Results, COVID-19, Study, Early, Detection, Diseases

13. Takeda Collaborates with Engitix to Target Fibrotic Liver Diseases

Published: Aug 26, 2020 | Tags: Takeda, Collaborates, Engitix, Target, Fibrotic Liver Diseases

14. Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia

Published: Aug 25, 2020 | Tags: Philips, B. Braun, Onvision Needle Tip Tracking Technology, Receive, US, FDA, 510 (k) Clearance, Regional Anesthesia

15. Qiagen to Launch Digital Test for Detecting SARS-CoV-2 Antibodies in the US

Published: Aug 25, 2020 | Tags: Qiagen, Launch, Digital Test, Detecting, SARS-CoV-2, Antibodies, US

16. Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

Published: Aug 26, 2020 | Tags: Novartis, Reports, Results, Asciminib, (ABL001), P-III, ASCEMBL Study, Chronic Myeloid Leukemia

17. Takeda and OVID Report Results of Soticlestat (TAK-935/OV935) in P-II ELEKTRA Study for Dravet Syndrome or Lennox-Gastaut Syndrome

Published: Aug 25, 2020 | Tags: Takeda, OVID, Report, Results, Soticlestat, TAK-935/OV935, P-II, ELEKTRA Study, Dravet Syndrome, Lennox-Gastaut Syndrome

18. ACADIA Acquires CerSci Therapeutics for $52.5M

Published: Aug 25, 2020 | Tags: ACADIA, Acquires, CerSci Therapeutics, $52.5M

19. AbbVie and Harvard University Collaborate to Develop Novel Therapies Against Emergent Viral Diseases

Published: Aug 25, 2020 | Tags: AbbVie, Harvard University, Collaborate, Develop, Novel Therapies, Against, Emergent Viral Diseases

20. AbbVie Exercises its Option to License Morphosys’ αvβ6 Integrin Inhibitor Program for Fibrotic Disease

Published: Aug 24, 2020 | Tags: AbbVie, Exercises, License, Option, Morphosys, αvβ6 Integrin, Inhibitor Program, Fibrotic Disease

21. BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

Published: Aug 24, 2020 | Tags: BeiGene, Signs, License, Supply, Agreement, Bio-Thera, BAT1706, biosimilar, bevacizumab, China

22. AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19

Published: Aug 25, 2020 | Tags: AstraZeneca, Initiates, P-I, Study, AZD7442, Against, COVID-19

23. Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan

Published: Aug 24, 2020 | Tags: Merck, Keytruda, (pembrolizumab), Receives, PMDA, Approvals, Japan

24. Bionano Genomics Acquires Lineagen to Facilitate the Clinical Adoption of Saphyr for Digital Cytogenetics

Published: Aug 24, 2020 | Tags: Bionano, Genomics, Acquires, Lineagen, Facilitate, Clinical Adoption, Saphyr, Digital Cytogenetics

26. Bayer and One Drop Collaborate to Develop Digital Therapies Across Multiple Therapeutic Areas

Published: Aug 24, 2020 | Tags:  Bayer, One Drop, Collaborate, Develop, Digital Therapies, Across, Multiple, Therapeutic Areas

27. BMS to Acquire Forbius for its AVID200 to Expand its Footprints in Oncology and Fibrosis

Published: Aug 24, 2020 | Tags: BMS, Acquire, Forbius, Adding, TGF-beta Inhibitor, Portfolio

28.  Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

Published: Aug 23, 2020 | Tags: Novartis, Triple Regimen, Fails, Meet, Primary Endpoint, P-III, COMBI-I, Study, Advanced Melanoma

29. ReiThera Reports First Patient Dosing with its COVID-19 Vaccine Candidate in Italy

Published: Aug 24, 2020 | Tags: ReiThera, Reports, First, Patient Dosing, COVID-19, Vaccine Candidate, Italy

30. Takeda to Divest its Consumer Health Unit to Blackstone for $2.3B in Japan

Published: Aug 24, 2020 | Tags:  Takeda, Divest, Consumer Health Unit, Blackstone,  $2.3B, Japan

31. Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy of HER2-Positive Early Breast Cancer

Published: Aug 23, 2020 | Tags: Chugai, Kadcyla, (trastuzumab emtansine), Receives, MHLW, Approval, Adjuvant Therapy, HER2-Positive, Early Breast Cancer

32. Vertex’s Kaftrio + Ivacaftor Receive the EC’s Approval to Treat Cystic Fibrosis in People Aged 12 Years and Older

Published: Aug 22, 2020 | Tags: Vertex, Kaftrio, Ivacaftor, Receive, EC, Approval, Cystic Fibrosis, Aged, 12 Years, Older

32. AstraZeneca Collaborates with RenalytixAI to Develop Precision Medicine for Chronic Diseases

Published: Aug 22, 2020 | Tags: AstraZeneca, Collaborates, RenalytixAI, Develop, Precision Medicine, Chronic Diseases

BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao

Shots:

  • BioNTech and Fosun collaborated to supply 10M doses of their BNT162 mRNA-based vaccine candidate against COVID-19 to Hong Kong SAR and Macao SAR, once approved
  • Fosun Pharma has signed the Letter of Intent with Jacobson for contemplated distribution of 10M doses of a vaccine targeting COVID-19 in the Chinese market
  • On Mar 13, 2020, the companies collaborated to jointly develop and commercialize the vaccine in Mainland China, Hong Kong, and Macau SAR and the Taiwan region. The P-I study of BNT162b1 has been initiated in China  and enrolled 144 participants

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

Is COVID the Rx for the Pharmaceutical Industry’s Reputation?

Darlene Dobry, Pharmaceutical Marketing

Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals

As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, the Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s response to this global public health crisis be the Rx for its tarnished reputation?

The Pharma industry has long been at the center of a firestorm, cited consistently as one of the most disliked and distrusted industries in the Gallup poll. It’s not surprising given the media coverage of CEO and company financial disclosures, patent trials, illegal activities, and questionable practices, legal settlements, price gouging, product recalls, and, most recently, its role in the devastating opioid epidemic. While the public’s high distrust and disdain are directed at “greedy” Pharma, prescription drug spending accounts for between 10-12% of total US healthcare costs, and now, in our time of greatest need, we turn to this industry to help us confront COVID-19. This pandemic has brought the committed, community-focused side of Pharma to the forefront, with its rapid and relentless pursuit to deliver the best science to solve this crisis.

Pharmaceuticals Collaborating for COVID’s Rx

There are brilliant and talented people in dozens of companies, both established manufacturers and small start-ups, working tirelessly to find a solution. Early efforts developed and produced testing assays to help the healthcare community identify and confirm the virus. The expanded focus now pursues proven treatments and vaccines. We see unexpected partnerships and creativity abound in the race to find answers that will address the crippling impact on public health and disrupt the economy and supply chains. Thomas Cueni, who leads the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in Geneva, notes, “the industry, which is traditionally fiercely competitive, has come together.”

For example, rivals like Sanofi and GSK are working to bring their innovative technologies together for a vaccine, with Astra-Zeneca and Oxford University signing a global development and distribution agreement for a CO-19 vaccine, Takeda and CoVIg-19 Alliance investing in plasma therapies, Regeneron and Sanofi conducting clinical trials for their jointly marketed Rheumatoid Arthritis drug Kevzara, and Pfizer and BioNTech are collaborating on an mRNA vaccine. There is an impressive number of ongoing trials to evaluate existing drugs for other diseases, including Gilead’s Remdesivir which now has FDA authorization for emergency use, and Gilead Sciences is applying for full authorization in the U.S., specialty biotech companies like Moderna and Novavax have also entered the race and are fast-tracked for their vaccine candidates.

Pharma’s Investments & Innovations during COVID-19

Beyond drug treatment and vaccine development, the industry has also brought new ingenuity and investment to fight COVID-19 and support the healthcare system; Johnson & Johnson is pledging $300M over ten years to help front-line workers, Astra-Zeneca donating 9M face masks to protect healthcare workers around the world, companies deploying their 3D printing capabilities to manufacture PPE and equipment, and Consumer Product companies producing hand sanitizers.

This industry, its brilliant researchers, and dedicated employees are unwavering in their mission to be a part of the solution by investing in unknowns despite the risk, diverting focus from other commercially available/development assets, and pioneering scientific innovation to confront COVID-19. With the sheer number of companies in this race, we stand the best chance of finding solutions and having the scale to keep up with the alarming projections of cases. It also helps to foster competition and encourage fair pricing. Despite Pharma‘s commitment to the cause, there continue to be critics who attribute Pharma’s efforts to capitalizing on a crisis and solely focused on profit. For those who feel Pharma should not make a profit from the deep investment, at this moment, it’s difficult to put a price on overcoming this enemy.

Pharma Marcom & PR during COVID

With the knowledge that consumers look to brands and companies that demonstrate social responsibility, philanthropic and community support, other industry leaders and I agree that there is an opportunity for Pharma to begin to evolve from some of the negative perceptions and elevate recognition of its essential role in moving us from “StayatHome” to “StayHealthy.” We are beginning to see public opinion improve throughout this pandemic, according to a recent Harris poll. From a marketing and public relations standpoint, I’m hopeful the Pharmaceutical Research and Manufacturers of America (PhRMA) will take this moment to elevate public awareness and highlight the level of corporate commitment and investment behind the scenes of this pandemic.

This is not self-serving. This is about scientific innovation, leadership during crisis, corporate responsibility, and saving lives. The industry should continue to demonstrate its thought leadership during this time through scientific publications and serving as an expert voice. As consumers increasingly search for information about the virus, vaccines, and treatment, Pharma needs to ensure the public has access to credible, scientifically-grounded content across media channels. Given the sequelae from this pandemic, there is also a tremendous need to address mental health and wellbeing. With the significant investment and access to mental health solutions and services, Pharma can also answer this call.

Pharma Marketing & Healthcare Marketing | COVID & Beyond

As advertising and communication experts, now is the time to step up and be even truer and more innovative pharmaceutical marketing agency partners. While our pharma, medical and healthcare clients are redirecting their efforts toward COVID-19, our own industry must be even more proactive and creative. Let’s bring pharmaceuticals strategically inventive marketing communication ideas and messaging programs to keep their brands and marketing more relevant during the COVID pandemic. Let’s help pharmas more effectively reach their increasingly “remote” customers and patients. Let’s drive better search rankings by developing more useful and authoritative content to educate online-engaged healthcare audiences. Let’s explore corporate campaigns and grass-roots programs to draw medical and pharmaceutical enterprises closer to their patient communities and genuinely bolster reputations. As experts in social media, let’s help Pharma be consistently compliant and proactively trustworthy participants in conversations concerning diseases & conditions. Let’s elevate the pharma industry’s core values currently on display through successfully inventive creativity and discerning innovation. As partners, let’s work tirelessly to create and focus insightful spotlights on the heroic efforts of our client-partners — healthcare and medical innovators dedicated to making “life-changing” differences within today’s life-changing public health crisis.

COVID and Healthcare Marketing — related articles: [Podcast] Hospital Crisis Management and Healthcare PR in the Age of COVID-19 | 5 Ways You Can Use Social Media and Digital Marketing to Help the Public During the COVID-19 Pandemic | Healthcare Marketing: Pause, Pivot, or Push for Success?

 

The post Is COVID the Rx for the Pharmaceutical Industry’s Reputation? appeared first on Healthcare Success.

PharmaShots Weekly Snapshot (Aug 17 -21 2020)

1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia

Published: Aug 20, 2020 | Tags:  BioMarin, Reports, NDA, Submission, US, FDA, Vosoritide, Children, Achondroplasia

2. Junshi and Impact to Establish Joint Venture for Senaparib (IMP4297) in China

Published: Aug 20, 2020 | Tags:  Junshi, Impact, Establish, Joint Venture, Senaparib, IMP4297, China

3. The US FDA Approves Kyprolis (carfilzomib) + Darzalex (daratumumab) + Dexamethasone in Two Dosing Regimens for R/R MM

Published: Aug 20, 2020 | Tags: US, FDA, Approves, Kyprolis, carfilzomib, Darzalex, (daratumumab), Dexamethasone, Two Dosing, Regimens, RRMM

4. AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

Published: Aug 21, 2020 | Tags: AstraZeneca, Imfinzi, durvalumab, Receives, MHLW, Approval, Extensive-Stage, Small Cell lung Cancer

5.  Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Published: Aug 20, 2020 | Tags: Pfizer, BioNTech, Regulatory Review, COVID-19, Vaccine,  October, 2020

6. Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis 

Published: Aug 20, 2020 | Tags: Novartis, Kesimpta, (ofatumumab), Receives, US ,FDA, Approval, First, Self-Administered Therapy, Relapsing, Multiple Sclerosis

7. Evotec and Centogene Expand their Collaboration to Target Gaucher Disease

Published: Aug 20, 2020 | Tags: Evotec, Centogene, Expand, Collaboration, Target, Gaucher Disease

8. BioSymetrics Signs an Agreement with Janssen and Sema4 to Utilize AI for the Prediction of COVID-19

Published: Aug 19, 2020 | Tags: BioSymetrics, Signs, Agreement, Janssen, Sema4, Utilize AI, COVID-19

9. Precision BioSciences Receives the US FDA’s Fast Track Designation for PBCAR0191 to Treat Advanced B-cell Precursor Acute Lymphoblastic Leukemia

Published: Aug 19, 2020 | Tags:  Precision BioSciences, Receives, US, FDA, Fast Track Disease Designation, PBCAR0191, Treat, Advanced, B-cell Precursor Acute Lymphoblastic Leukemia

10. Qiagen Launches QIAseq SARS-CoV-2 Primer Panel for Tracking COVID-19 Mutations and Strains

Published: Aug 18, 2020 | Tags:  Qiagen, Launches, QIAseq SARS-CoV-2, Primer Panel, Tracking, COVID-19, Mutations, Strains

11. Sorrento Files IND for STI-1499 (COVI-GUARD) in Patients Hospitalized with COVID-19

Published: Aug 19, 2020 | Tags:  Sorrento, Files, IND, STI-1499, COVI-GUARD, Patients, Hospitalized, COVID-19

12. Fitbit Reports Results of its COVID-19 Study for Early Detection of Diseases

Published: Aug 19, 2020 | Tags: Fitbit, Report, Results, COVID-19, Study, Early, Detection, Diseases

13. Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Published: Aug 19, 2020 | Tags: Roche, Tecentriq, Bevacizumab, Receive, Health Canada, Approval, 1L, Treatment,  Unresectable,  Metastatic, Hepatocellular Carcinoma

14. The US FDA Rejects Gilead’s Filgotinib Due to Toxicity Issues   

Published: Aug 19, 2020 | Tags: The US, FDA, Rejects, Gilead, Filgotinib, Toxicity Issues

15. Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B

Published: Aug 19, 2020 | Tags: Johnson & Johnson, Acquire, Momenta Pharmaceuticals,  $6.5B

16. Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe Chronic Rhinosinusitis with Nasal Polyposis

Published: Aug 18, 2020 | Tags: Sanofi, Dupixent, dupilumab, Receives,  Health Canada, Approval,  Severe, Chronic Rhinosinusitis,  Nasal Polyposis

17. Novo Nordisk Collaborates with Evotec to Develop Therapies Targeting Chronic Kidney Disease 

Published: Aug 18, 2020 | Tags: Novo Nordisk, Collaborates, Evotec, Develop Therapies, Targeting, Chronic Kidney Disease

18. Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

Published: Aug 19, 2020 | Tags: Regeneron, Collaborates, Roche, Improve, Global Supply, REGN-COV2, Against, COVID-19

19. Lilly and Innovent Report the Global Expansion of their Alliance for Tyvyt (sintilimab)

Published: Aug 18, 2020 | Tags: Lilly, Innovent, Report, Global Expansion, Alliance, Tyvyt, sintilimab

20. G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

Published: Aug 17, 2020 | Tags: G1 Therapeutics, Reports, US, FDA, Acceptance, Priority Review, NDA, Trilaciclib, SCLC

21.PTC Reports the EMA’s Acceptance of MAA for Evrysdi (risdiplam) to Treat SMA

Published: Aug 17, 2020 | Tags: PTC, Reports, EMA, Acceptance, MAA, Evrysdi, risdiplam, SMA

22. Gilead Expands its Oncology Collaboration with Tango for ~$6.3B   

Published: Aug 17, 2020 | Tags: Gilead, Expand, Oncology Collaboration, Tango, $6.3B

23. AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer

Published: Aug 19, 2020 | Tags: AstraZeneca, Imfinzi, durvalumab, Receives, US, FDA, Priority Review, Less Frequent, Fixed-Dose Use, NSCLC, Bladder Cancer

24. AstraZeneca Collaborates with mAbxience to Produce COVID-19 Vaccine in Latin America

Published: Aug 17, 2020 | Tags: AstraZeneca, Collaborates, mAbxience, Produce, Covid-19, Vaccine, Latin America

26. Gilead Expands its Oncology Collaboration with Tango for ~$6.3B

Published: Aug 17, 2020 | Tags:  Gilead, Expand, Oncology Collaboration, Tango, Worth, ~$6.3B

27. Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

Published: Aug 17, 2020 | Tags: Roche, Enspryng, (satralizumab-mwge), Receives,  US, FDA, Approval,  Neuromyelitis Optica Spectrum Disorder

28. Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab Biosimilar in China

Published: Aug 17, 2020 | Tags: Henlius, HLX02, Receives, NMPA, Approval, First, Trastuzumab, Biosimilar, China

29.Abeona Signs a License and Inventory Purchase Agreements with Taysha for ABO-202 to Treat CLN1 Disease (Infantile Batten disease)

Published: Aug 17, 2020 | Tags: Abeona Therapeutics, Signs, License, Inventory Purchase, Agreements, Taysha Gene Therapies, ABO-202, CLN1 Disease

30.BMS Signs an Exclusive Worldwide License Agreement with Dragonfly Therapeutics for DF6002

Published: Aug 17, 2020 | Tags:  BMS, Signs, Exclusive, Worldwide, License Agreement, Dragonfly Therapeutics, DF6002

31. Sanofi to Acquire Principia Biopharma for ~$3.68B

Published: Aug 17, 2020 | Tags: Sanofi, Acquire, Principia Biopharma, $3.68B

Coronavirus pharma news round-up 21/08/20

New insights into smell and taste loss symptoms, artificial intelligence and further encouraging data from a vaccine candidate hit the headlines this week as the COVID-19 coronavirus pandemic continues.

Here we highlight the biggest R&D, market access and digital coronavirus news of the past week.

  • Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. There are no vaccines approved for COVID-19 and governments across the world are striking deals with various manufacturers to get early access once regulators give them the rubber stamp.
  • Could AI prevent future pandemics by developing an armoury of drugs that work against all coronaviruses? This is a question that a consortium of European pharma companies hopes to answer as it aims to rapidly develop new therapies to combat the pandemic.
  • Roche has agreed to help Regeneron manufacture its COVID-19 antibody cocktail REGN-COV2, which started late-stage clinical testing a few weeks ago, in a deal that could more than triple supplies of the drug if it gets approved.
  • Smell and taste loss associated with COVID-19 differs from that experienced by patients with common colds or flu, according to researchers who said the symptom could be used to quickly identify coronavirus infections in settings such as airports or emergency departments.
  • Health Secretary Matt Hancock is planning to dissolve Public Health England and replace it with a new agency dedicated to responding to pandemics, according to reports. The plan is to implement a new body modelled on the independent Robert Koch Institute in Germany, which has been held up as having done well in weathering COVID-19, in part at least because of a well-organised and large-scale testing programme early on.
  • Shares in Netherlands biotech Kiadis rose sharply on the news that it would start developing a natural killer (NK) cell therapy for COVID-19, but later lost most of the gains on what looks like profit-taking.
  • The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million.

 

The post Coronavirus pharma news round-up 21/08/20 appeared first on .

Pfizer/BioNTech say COVID-19 jab on track for approval by year-end

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial.

There are no vaccines approved for COVID-19 and governments across the world are striking deals with various manufacturers to get early access once regulators give them the rubber stamp.

The latest data from a phase 1 study in the US showed that seven days after a second dose at 30 micrograms, the vaccine produced 3.8 times more neutralising antibodies than in younger patients aged 18-55 recovering from SARS-CoV-2 infection.

In older adults aged 65-85 treated with the vaccine candidate codenamed BNT162b2 there were 1.6 times more neutralising antibodies than in recovering patients.

Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the participants, the companies said.

The data builds on results announced last month, which also showed the antibody response and suggested that the vaccine produces a T-cell response against the virus.

Those results helped the companies choose BNT162b2 from a group of similar candidates for an ongoing phase 2/3 global study in up to 30,000 participants.

This began in July and has so far enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission.

Assuming the trial is a success, Pfizer and Germany’s BioNTech said they are on track to ask for a regulatory review as early as October, paving the way to supply up to 100 million doses by year end if the vaccine is authorised.

Pfizer and BioNTech are running a parallel trial in Germany and plan to announce further results from that in the “near future”.

There could be up to 1.3 billion doses manufactured by the end of next year, the companies said.

The vaccine is one of 30 potential vaccines identified by the World Health Organization as being in clinical development, with AstraZeneca and Oxford University top of the list.

The post Pfizer/BioNTech say COVID-19 jab on track for approval by year-end appeared first on .

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Shots:

  • The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the participants
  • In P-I study, BNT162b2 (@7days after the second dose of 30μg) elicited SARS-CoV-2–neutralizing GMTs in younger adults (18-55yrs.) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age), it elicited a neutralizing GMT 1.6 times the GMT of the same panel
  • The companies anticipate commencing the global (Ex- China) P-II/III study of BNT162b2 in up to 30,000 participants that started in Jul’2020, which has to date enrolled 11,000+ patients including in areas with significant SARS-CoV-2 transmission

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

Related News: Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

BioNTech and Fosun Pharma Initiate Clinical Trial of BNT162b1 Against COVID-19 in China

Shots:

  • The P-I study will evaluate the safety and immunogenicity of the vaccine as well as confirm dose selection in ~144 healthy subjects aged 18-55 and >55 yrs. As part of the two-dose cohort design, subjects will receive two injections (prime-boost), 21 days apart  BNT162b1 vs PBO
  • The dose range was determined based on early data from clinical trials conducted in Germany and the US. The participants will be dosed in Taizhou clinical P-I center, Jiangsu province
  • BioNTech will provide the clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in EU while Fosun Pharma will exclusively commercialize the vaccine in Mainland China, Hong Kong, and Macau Special Administration Regions and in Taiwan if received approval in China

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

Related News: Fosun Pharma Signs an Agreement with BioNTech to Develop and Commercialize BNT162 for COVID-19




Regeneron pairs with BioNTech on melanoma immunotherapy

Regeneron and Sanofi’s PD-1 inhibitor Libtayo will be tested in tandem with a cancer vaccine developed by BioNTech in melanoma in people who have failed treatment with other checkpoint inhibitors.

The two companies will carry out a phase 2 trial of Libtayo (cemiplimab) alongside BioNTech’s mRNA cancer immunotherapy BNT111, which is designed to stimulate immune responses against four cancer-related antigens: NY-ESO-1, MAGE-A3, tyrosinase, and TPTE.

The recruitment of BioNTech as a partner in melanoma comes after Regeneron and Sanofi decided to abandon development of Libtayo with their recently-approved anti-CD38 drug Sarclisa (isatuximab) in that indication.

Melanoma was the first cancer to be targeted by the checkpoint inhibitor class several years ago when Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck & Co/MSD’s Keytruda (pembrolizumab) were both approved as second-line treatments for the disease within a few weeks of each other.

Since then, PD-1/PD-L1 inhibitors have moved into the first-line setting, and at the moment the combination of Opdivo and BMS’ CTLA4 inhibitor Yervoy (ipilimumab) – another immune checkpoint inhibitor – has become the go-to therapy for many oncologists.

The problem is that while 30% to 40% of melanoma patients get a long-lasting response to checkpoint inhibitor therapy, in the majority the drugs either don’t work at all or lose their potency over time allowing the cancer to come back.

Regeneron and BioNTech are hoping that adding BNT111 to anti-PD-1 therapy with Libtayo will overcome the resistance mechanisms that are present in some tumours, and increase the proportion of patients who respond to immunotherapy.

The phase 2 trial will recruit patients with advanced melanoma that can’t be treated with surgery who are refractory to or have relapsed after PD-1 drugs, and the costs of running it will be shared by the two partners. It is due to start before the end of the year.

“The combination of Libtayo and BNT111…has the potential to augment the immune system’s ability to effectively recognise melanoma in multiple ways and hopefully improve immune targeting to control the cancer,” commented Regeneron’s head of translational science and oncology Israel Lowy.

Libtayo was a late entrant into the PD-1/PD-L1 inhibitor market and while it has been able to carve out a small niche in cutaneous squamous cell carcinoma (CSCC), another form of skin cancer, it’s still a bit player.

Sanofi reported ex-US sales of €27 million ($32 million) for Libtayo in the first half of this year. Regeneron records US sales, but isn’t due to report its second quarter until later this week. It made just under $62 million from the drug in the first quarter.

The two partners are hoping to grow the drug with new indications such as basal cell carcinoma – another form of skin cancer – and non-small cell lung cancer (NSCLC), although they will face still competition in the latter from Merck’s market leader Keytruda.

Meanwhile, BNT111 is the lead candidate in BioNTech’s FixVacc cancer vaccines programme, which dominates its pipeline despite the recent close attention to the German biotech’s coronavirus candidate, partnered with Pfizer.

It is one of five FixVacc vaccines in early-stage clinical testing, along with candidates for prostate, head and neck,  ovarian and triple-negative breast cancer.

The post Regeneron pairs with BioNTech on melanoma immunotherapy appeared first on .

PharmaShots Weekly Snapshot (Jul 27- 31, 2020)

 1.  Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease 

Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease

2.  Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

Published: Jul 30, 2020 | Tags: Johnson & Johnson, Initiates, P-I/IIa, Study,  Ad26,  US, Belgium

 3. Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer

Published: Jul 31, 2020 | Tags: Roche, Receives, US, FDA, Approval, VENTANA HER2 Dual ISH Test, CDx, Identify, Breast Cancer

4. Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

Published: Jul 31, 2020 | Tags: Takeda, Pevonedistat, Receives, US, FDA, Breakthrough Therapy Designation, Patients, Higher-Risk Myelodysplastic Syndromes, HR-MDS

5. Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Published: Jul 31, 2020 | Tags: Roche, Tecentriq, Cotellic, Zelboraf, Receives, US, FDA, Approval, Patients, Advanced, Melanoma

6. Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

Published: Jul 30, 2020 | Tags: Sangamo, Signs, Worldwide, License Agreement, Novartis, Develop, Genomic Therapies, Three, Neurodevelopmental Targets

7.  Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

Published: Jul 30, 2020 | Tags: Eli Lilly, Reports, Results, Jardiance, empagliflozin, P-III, EMPEROR Trial, Heart Failure, Patients, Reduced Ejection Fraction, with and without, Diabetes

8.  AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

Published: Jul 29, 2020 | Tags: AstraZeneca, Tagrisso, Osimertinib, Receives, US, FDA, BT, Designation, Adjuvant Treatment, Patients, Stage IB-IIIA EGFR-Mutated, Lung Cancer

9. Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Published: Jul 30, 2020 | Tags: Glenmark, Report, Results, FabiFlu, favipiravir, P-III, Clinical Study, Patients, Mild, Moderate, COVID-19

10. UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

Published: Jul 29, 2020 | Tags: UCB Canada, Brivlera, brivaracetam, Receives, Health Canada, Approval, Treat, Partial-Onset Seizures, Pediatric, Epilepsy Patients

11. BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

Published: Jul 23, 2020 | Tags: BARDA, Signs, Multi-Year Agreement, Regeneron, REGN-EB3, National Preparedness

13.  Baxter and Ayogo Expand their Partnership to Advance Digital Health Solution for Home Dialysis

Published: Jul 29, 2020 | Tags: Baxter, Ayogo, Expand, Partnership, Advance, Digital, Health Solution, Home Dialysis

14.  Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

Published: Jul 29, 2020 | Tags: Merck, MK-6482, Receives, US, FDA, Breakthrough Therapy Designation, Treat, Patients, Von Hippel-Lindau Disease- Associated, Renal Cell Carcinoma

15AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

Published: Jul 28, 2020 | Tags: AbbVie, Reports, Results, Rinvoq, upadacitinib, P-III, AD Up, Study, Patients, Atopic Dermatitis

16.   Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Published: Jul 29, 2020 | Tags: Roche, Actemra/RoActemra, tocilizumab, Fails, Meet, Primary Endpoint, P-III, COVACTA Study, Patients, COVID-19, Associated Pneumonia

17.  Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Published: Jul 28, 2020 | Tags: Sanofi, GSK, Sign, Agreement, UK, Government, Supply, ~60M, Doses, COVID-19, Vaccine

18.  Eli Lilly’s P-tau217 Blood Test Demonstrate High Accuracy in Diagnosis of Alzheimer’s Disease

Published: Jul 29, 2020 | Tags: Eli Lilly, P-tau217, Blood Test, Demonstrate, High Accuracy, Diagnosis, Alzheimer’s Disease

19.  Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease

Published: Jul 28, 2020 | Tags: Roche, UCB, Collaborate, Develop, UCB0107,  Alzheimer’s Disease

20.  Zebra Medical Receives the US FDA’s Approval for its HealthMammo Mammography Tool

Published: Jul 27, 2020 | Tags: Zebra Medical, Receives, US, FDA, Approval, HealthMammo, Mammography Tool, Oncology, Breast Cancer

21.   AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Published: Jul 27, 2020 | Tags: AstraZeneca, Reports, Results, Farxiga, P-III, DAPA-CKD, Study, Patients, Chronic Kidney Disease

22.  Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

Published: Jul 28, 2020 | Tags: Eli Lilly, Amends, 2013, Agreement, Chi-Med, Commercialize, Elunate, Fruquintinib, China

23. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

Published: Jul 27, 2020 | Tags: AstraZeneca, Signs, Agreement, Emergent BioSolutions, Expand, Manufacturing, AZD1222, COVID-19

24.  Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Published: Jul 28, 2020 | Tags: Pfizer, BioNTech, Initiate, P-II/III, Global Study, Lead, mRNA, Vaccine, Candidate, Against, COVID-19

25.  Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India

Published: Jul 26, 2020 | Tags:  Three, Pharma, Companies, Launch, Favipiravir, COVID-19, India

26. Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

Published: Jul 27, 2020 | Tags: Kite, Tecartus, brexucabtagene autoleucel, Receives, US, FDA, Approval, First, Cell-Based, Gene Therapy, Relapsed, Refractory, MCL

27.   Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Published: Jul 26, 2020 | Tags: Centus Biotherapeutics, Equidacent, (bevacizumab, biosimilar, Receives, CHMP, Positive Opinion, Treatment, Multiple Cancer Indications

28.   AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Published: Jul 27, 2020 | Tags: AstraZeneca, Signs, Agreement, Daichii Sankyo, Develop, Commercialize, DS-1062, Worth, Up to, $6B, Global, Oncology,

29. Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer

Published: Jul 27, 2020 | Tags: Sorrento, Acquire, SmartPharm, Develop, Pipeline, Gene-Encoded, Therapeutic Antibodies, Targeting, COVID-19, Cancer, Oncology, Global




Pfizer, BioNTech score deal to supply 120M Covid-19 vaccine doses to Japan

Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical trial success and regulatory approval, they would supply the vaccines in early 2021, ahead of the rescheduled Tokyo Olympics.

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.

75. Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Jul 30, 2020 | Clinical Trial

74. Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Jul 29, 2020 | Collaboration

73. UK’s Recovery Continues to Test Roche’s Tocilizumab in COVID-19

Jul 29, 2020 | Clinical Trial

72. Roche’s Actemra/RoActemra Fails in COVID-19 Trial

Jul 29, 2020 | Clinical Trial

71. Green Cross’ GC5131A Receives the Regulatory Approval for P-II Trial for COVID-19

Jul 29, 2020 | Regulatory

70. Relief’s RLF-100 (aviptadil) Receives the US FDA’s Expanded Access Protocol to Treat Respiratory Failure in COVID-19

Jul 29, 2020 | Regulatory

69. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19  

Jul 28, 2020 | Regulatory

68. Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Jul 28, 2020 | Clinical Trial

67. Gilead’s Veklury (Remdesivir) Health Canada’s Marketing Authorization with Conditions (NOC/c) to Treat COVID-19 

Jul 28, 2020 | Regulatory

66. Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India  

Jul 27, 2020 | Launch

65. Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer  

Jul 27, 2020 | Collaboration

64. AI Therapeutics Reports Initiation of P-II Trial of LAM-002A (apilimod dimesylate) for COVID-19 Patients

Jul 27, 2020 | Clinical Trial

63. Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)  

July 24, 2020 | Clinical Trial

62. Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Jul 27, 2020 | Clinical Trial

61. The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19  

Jul 27, 2020 | Launch

60. Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India  

Jul 27, 2020 | Launch

59. Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Jul 27, 2020 | Clinical Trial

58. AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Jul 27, 2020 | Clinical Trial

57. Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19  

Jul 20, 2020 | Diagnostic

56. Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Jul 20, 2020 | Clinical Trial

55. Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India  

Jul 16, 2020 | Clinical Trial

54. Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Jul 16, 2020 | Launch

53. AstraZeneca and the University of Oxford to Share Positive News on its COVID-19 Vaccine Imminently

Jul 15, 2020 | Collaboration

52. 3M Collaborates with MIT to Develop Paper-Based Diagnostic Test for COVID-19

Jul 13, 2020 | Collaboration

51. Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July, 2020

Jul 13, 2020 | Clinical Trial

50. The International Fencing Federation (FIE) Reports the Global COVID-19 Support Plan

July 13, 2020 | Launch

49. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms  

Jul 12, 2020 | Regulatory

48. The Zimbabwe Government to Launch US $10M COVID-19 Relief Package

Jul 11, 2020 | Launch

47. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms

Jul 10, 2020 | Regulatory

46. AstraZeneca Collaborates with ProteinQure to Design Novel Peptide Therapeutics

Jul 10, 2020 | Collaboration

45. Cipla Launches Cipremi at $53.34 per Vial in India

Jul 10, 2020 | Launch

44. The Health Ministry of Kyrgyzstan Reports Supply of Avifavir an Antiviral Drug form Russia

Jul 09, 2020 | Regulatory

43. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Clinical Trial

42. Angion Commences P-II Study of ANG-3777 in Patients with Acute Lung Injury Associated with COVID-19 Pneumonia in Brazil

Jul 08, 2020 | Clinical Trial

41. The European Commission Signs an Agreement with Roche and Merck to Supply their COVID-19 Therapies in EU

Jul 09, 2020 | Collaboration

40. GSK and Medicago to Initiate P-I Trial of Plant-Based COVID-19 Vaccine in July 2020

Jul 08, 2020 | Clinical Trial

39. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Collaboration  

38. Innovation Pharmaceuticals Reports Results Brilacidin in COVID-19 Clinical Trial

 Jul 07, 2020 | Clinical Trial

37. Reven Reports Publication of Two COVID-19 Articles for RJX Platform

Jul 07, 2020 | Regulatory

36. Emergent Signs a Five-Year Manufacturing Services Agreement with Janssen for Ad26.COV2-S to Treat COVID-19  

Jul 07, 2020 | Collaboration   

35. Constant Therapeutics’ TXA127 will be Evaluated in P-II Trial for COVID-19 Patients

Jul 07, 2020 | Clinical Trial

34. Sinovac’s P-III COVID-19 Trial Receives the Brazilian Regulator Approval  

Jul 07, 2020 | Regulatory

33. Nasus Pharma Reports Results of TaffiX as a Intranasal Antiviral Protection Against SARS-CoV-2

Jul 07, 2020 | Clinical Trial

32. Mylan Receives EUA Approval for its Remdesivir to Treat COVID-19  

Jul 07, 2020 | Regulatory

31. Diffusion Pharmaceuticals Reports IND Submission for P-Ib/IIb COVID-19 Clinical Program with TSC to the US FDA

Jul 07, 2020 | Clinical Trial

30. Novavax to Receive $1.6B Funds from the US

Jul 07, 2020 | Grants

29. Aboundbio Signs an Agreement with SaudiVax for COVID-19

Jul 07, 2020 | Collaboration

28. Hepion Pharmaceuticals Reports Preclinical Results of CRV431 for Treating COVID-19

Jul 07, 2020 | Clinical Trial

27. Therapeutic Solution Reports Submission of Publication of Preclinical Data on StemVac for Supporting COVID-19 Indication

 Jul 07, 2020 | Clinical Trial

26. Regeneron with its Partner NIAID Report the Initiation of P-III Trial to Evaluate REGN-COV2 for Treatment and Prevention of COVID-19  

Jul 06, 2020 | Clinical Trial

25. Mylan’s Remdesivir Lyophilized Powder for Injection Receives the DCGI Accelerated Approval for Restricted Emergency Use in COVID-19 Patients in India    

Jul 06, 2020 | Regulatory

24. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

23. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Trial for Patients with COVID-19 in the US

Jul 03, 2020 | Clinical Trial

22. Moderna Reports the Enrollment of P-II Trial for its mRNA-1273 to Treat COVID-19  

Jul 03, 2020 | Clinical Trial

21. Sorrento Selects T-VIVA-19 as a Targeted Protein Vaccine Candidate Against COVID-19

Jul 02, 2020 | Clinical Trial

20. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside Japan

Jul 02, 2020 | Collaboration

19. Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in P-I/II Study Against COVID-19

Jul 02, 2020 | Clinical Trial

18. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

17. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Study for Patients with COVID-19 in the US

Jul 02, 2020 | Clinical Trial

16.  Phase II Study of MRx-4DP0004 in Patients Hospitalized with COVID-19 Open for Enrolment

Jul 02, 2020 | Clinical Trial

15.  Regulatory Authorities Step Up Cooperation in Connection with COVID-19

Jul 02, 2020 | Regulatory

14. Austria Donates €2M to CEPI to Support COVID-19 Vaccine Programmes

Jul 02, 2020 | Grant

13. Liminal BioSciences Joins CoVIg Plasma Alliance to Develop New COVID-19 Therapy

Jul 02, 2020 | Collaboration

12. Biophytis Receives FDA IND Clearance for COVA, a P-II/III Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

Jul 02, 2020 | Clinical Trial

11.  EUSA Receives the US FDA Approval of P-III Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

Jul 02, 2020 | Clinical Trial

10.  Moderna Faces Delay in its COVID-19 Vaccine Trial

Jul 02, 2020 | Clinical Trial

9. Anivive Initiates Two Pre-Clinical Studies of GC376 for the Treatment of COVID-19

Jul 02, 2020 | Clinical Trial

8. MediciNova Announces Opening of IND for MN-166 (ibudilast) for Prevention of Acute Respiratory Distress Syndrome in Patients with COVID-19

Jul 01, 2020 | Clinical Trial

7. GoldenBiotech’s Antroquinonol Receives FDA Approval on COVID-19 P-II Trial in the US

Jul 01, 2020 | Regulatory

6. New Study Highlights Senhwa Biosciences Silmitasertib as Potential Treatment for COVID-19

Jul 01, 2020 | Clinical Trial

5. International Regulators Provide Guiding Principles for COVID-19 Clinical Trials

Jul 01, 2020 | Regulatory

4.  FibroGenesis Identifies Mechanism Responsible for Blocking COVID19-Like Lung Inflammation

Jul 01, 2020 | Clinical Trial

3. Inimmune Awarded $2M SBIR to Advance Vaccine Technologies

Jul 01, 2020 | Grant

2. UNION Receives Danish Medicines Agency’s Approval to Initiate Clinical Study With Niclosamide for Treatment of COVID-19

Jul 01, 2020 | Clinical Trial

1. FAMHP Facilitates and Supports the Development of COVID-19 Treatments and Vaccines

Jul 01, 2020 | Regulatory

Related Post : Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – June 2020




Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Shots:

  • The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2
  • The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate up to 30,000 participants in a ratio (1:1)  aged 18 – 85yrs. started in the US and is expected to include ~120 sites globally 
  • Assuming clinical success, companies expect to seek regulatory approval as early as Oct’2020. Following the approval, the companies currently aim to supply globally up to 100M doses by the end of 2020 and ~1.3B doses by the end of 2021. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus-neutralizing Abs and has received the US BT designation

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

Related News: Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19




PharmaShots Weekly Snapshot (Jul 20- 24, 2020)

 1.  Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis 

Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, filgotinib, Receive, CHMP, Positive Opinion,  Moderate, Severe, Rheumatoid Arthritis

2.  Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs

Published: Jul 24, 2020 | Tags: Synaffix, Expands, Existing Collaboration, ADC, Explore, Two Additional Programs

 3. Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)

Published: Jul 23, 2020 | Tags: Zydus, Initiate, Clinical Study, Desidustat, Patients, Chemotherapy Induced Anemia, CIA

4. AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

Published: Jul 24, 2020 | Tags: AstraZeneca, Breztri Aerosphere, Receives, US, FDA, Approval, Maintenance Treatment, COPD

5. Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder

Published: Jul 17, 2020 | Tags: Abbott, IOS-Compatible App, Receives, US, FDA, Approval, Patients, Neurological Disorder

6. BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia

Published: Jul 23, 2020 | Tags: BioMarin, Reports, Submission, MAA, EMA, Vosoritide, Treat, Children, Achondroplasia

7.  Ovid Therapeutics and University of Connecticut Collaborate to Accelerate the Development of OV101 (gaboxadol) for Angelman Syndrome

Published: Jul 22, 2020 | Tags: Ovid Therapeutics, University of Connecticut, Collaborate, Accelerate, Development, OV101, gaboxadol, Angelman Syndrome

8.  Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

Published: Jul 22, 2020 | Tags: Genentech, Reports, Results, Port Delivery System, Ranibizumab, P-III, Archway Study, Neovascular Age-Related Macular Degeneration

9. Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Published: Jul 22, 2020 | Tags: Glenmark, Report, Results, FabiFlu, favipiravir, P-III, Clinical Study, Patients, Mild, Moderate, COVID-19

10. Daiichi Sankyo Signs a Research Agreement Gustave Roussy for DS-1062 and Patritumab Deruxtecan to Treat Lung and Breast Cancer

Published: Jul 23, 2020 | Tags: Daiichi Sankyo, Signs, Research Agreement, Gustave Roussy, DS-1062, Patritumab Deruxtecan, Treat, Lung, Breast Cancer

11. Chugai and Biofourmis Collaborate to Develop Solutions for Digitally Measuring Endometriosis Pain

Published: Jul 23, 2020 | Tags: Chugai, Biofourmis, Collaborate, Develop, Solutions, Digitally Measuring, Endometriosis Pain

13.  AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis

Published: Jul 22, 2020 | Tags: AbbVie, Reports, Results, Rinvoq, upadacitinib, Monotherapy, P-III, Measure Up 2, Study, Atopic Dermatitis

14.  Evotec Collaborates with Quantro Therapeutics to Discover and Develop Novel Therapies for Cancer and Other Diseases

Published: Jul 22, 2020 | Tags: Evotec, Collaborates, Quantro Therapeutics, Discover, Develop, Novel, Therapies, Cancer, Other Diseases

15Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

Published: Jul 20, 2020 | Tags: Boston Scientific, Receives, US, FDA, Approval, Next-Generation, WATCHMAN FLX, Left Atrial, Appendage Closure Device

16.   Gilead to Acquire Tizona’s Stakes for $300M

Published: Jul 22, 2020 | Tags: Gilead, Acquire, Tizona, Stake, $300M, AbbVie, TTX-080, TTX-03

17.  Biocon Collaborates with Voluntis on Digital Therapeutics for Insulins

Published: Jul 21, 2020 | Tags: Biocon, Collaborates, Voluntis, Digital Therapeutics, Insulins

18.  Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

Published: Jul 22, 2020 | Tags: Paige, Receives, US, FDA, 510(k), Clearance, FullFocus Viewer, Use, Digital Pathology

19.  The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19

Published: Jul 21, 2020 | Tags: The UK, Government, Launch, AbC-19, Lateral Flow, Free Finger-Prick Test, COVID-19

20.  Roche Collaborates with Jnana Therapeutics to Discover Novel Therapies to Treat Immune-Mediated and Neurological Diseases

Published: Jul 21, 2020 | Tags: Roche, Collaborates, Jnana Therapeutics, Discover, Novel Therapies, Treat, Immune-Mediated, Neurological Diseases

21.   Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India

Published: Jul 20, 2020 | Tags: Mylan, Launches, Remdesivir, Under, Brand Name, Desrem, COVID-19, India

22.  Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Published: Jul 21, 2020 | Tags: Pfizer, BioNTech, Elicits, Strong, T-cell, Response, P-I/II, Study, Against, COVID-19, Germany

23. AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Published: Jul 20, 2020 | Tags: AstraZeneca, Oxford University, AZD1222, Delivers, Strong, Immune Response, P-II/III, COV001, Study, Against, COVID-19  

24.  Royalty Pharma Acquires PTC’s Royalty Interest in Risdiplam for $650M

Published: Jul 19, 2020 | Tags: Royalty Pharma, Acquires, PTC, Royalty Interest, Risdiplam,  $650M

25.  Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19

Published: Jul 19, 2020 | Tags:  Quest Diagnostic, Receives, US, FDA, First, EUA, Sample Pooling, COVID-19

26. Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis

Published: Jul 19, 2020 | Tags: Roche, Signs, RWD, Collaboration, PicnicHealth, Create, Personalized Treatment, Patients, Multiple Sclerosis

27.   Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Published: Jul 19, 2020 | Tags: Celltrion, Initiates, P-I, Study, COVID-19, Antibody Treatment, South Korea

28.   GSK to Acquire 10% stake in CureVac for $163M

Published: Jul 20, 2020 | Tags: GSK, Acquire, 10%, Stake, CureVac, $163M




US places $1.95 billion order for Pfizer/BioNTech’s COVID-19 vaccine

The US government has agreed to pay Pfizer and BioNTech $1.95 billion to secure access to 100 million doses of their coronavirus vaccine on approval, just days after promising results in a clinical trial.

The deal – part of the Trump administration’s Operation Warp Speed that aims to deliver 300 million coronavirus vaccines in early 2021 – has ignited fears of “vaccine nationalism” – wealthy nations buying up potential COVID-19 vaccines and restricting available supplies to countries without the same spending power. 

Last month, for example, hackles were raised after the US acquired most of the global supply of Gilead’s COVID-19 drug remdesivir until September, and there are concerns that vaccines will follow a similar path.

Along with the initial order for 100 million doses of BNT162, the federal government has also agreed a facility to acquire another 500 million, and says it will make them available for free to US citizens.

It is the largest deal to be signed under Warp Speed, and comes after the UK placed an order for 30 million doses of BNT162 for delivery this year and next.

Pfizer and BioNTech said in May they expected to have capacity to make “millions” of doses of the shot in 2020, rising to “hundreds of millions” next year, so at face value the UK and US orders seem to cover most of the near-term supply.

BioNTech chief executive Ugur Sahin said however that the partners “are also in advanced discussions with multiple other government bodies and we hope to announce additional supply agreements soon.”

The two partners say they also intend to start supply discussions with the COVAX programme – run by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO) – which has been set up to enable equitable access to coronavirus vaccines around the globe.

In the meantime, the US has also placed big orders for coronavirus vaccines developed by Oxford University/AstraZeneca and Novavax as part of agreements that also include clinical development funding, and has provided development funding to Johnson & Johnson and Moderna under Operation Warp Speed.

The BNT162 programme, which is based on BioNTech’s mRNA technology, is currently testing at least four different vaccine candidates in clinical trials. A large-scale trial of the front-runner shot in 30,000 is due to start this month and could form the basis of an emergency-use approval, perhaps as early as October.

Price ceiling?

The size of the deal puts a nominal price per vaccine dose of around $19.50, which Bloomberg notes will likely set a price ceiling on what other vaccine developers can charge for their candidates if approved. Pfizer and BioNTech are testing one- and two-dose regimens of BNT162.

It still allows profit to be made on the vaccines, and Bloomberg analyst  Sam Fazeli says that it could allow Pfizer to make a windfall of more than $15 billion, assuming the vaccine confers protection with one dose.

Earlier this week, pharma executives told a congressional hearing in the US that they could not commit to providing coronavirus vaccines at cost over the long-term, but would do so during the pandemic.

The US currently has more than 4 million confirmed cases of COVID-19, with more than 145,000 deaths

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Pfizer, BioNTech get $1.95B from HHS to supply Covid-19 vaccine

The companies will supply 100 million doses of the vaccine by the end of the year, and the government will have the option to acquire 500 million more. However, the FDA must grant an authorization based on its safety and efficacy, for which there are only preliminary data so far.

Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Shots:

  • The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 neutralizing titers following the second dose in an ongoing P-I/II study in Germany
  • The results divulge that BNT162b1 candidate induced strong CD4+ and CD8+ T-cell responses. BNT162b1 elicits RBD-specific, interferon-g+, IL-2+, CD8+ T cells in immunized participants indicating a strong potential for cell-mediated anti-viral activity
  • BNT162b1 induced broad neutralizing activity in pseudovirus neutralization assays across a panel of 16 SARS-CoV-2 RBD variants, including D614G strain. Data from German and US P-I/II studies will be used by the two companies to determine a dose level and select among multiple vaccine candidates to seek to progress in global P-IIb/III safety and efficacy trial, expected to begin in Jul’20 end

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

Related News: Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in P-I/II Study Against COVID-19




UK announces COVID-19 vaccine deals with BioNTech/Pfizer and Valneva

The UK has secured 90 million doses of two different COVID-19 vaccines from BioNTech/Pfizer and Valneva, with an option of 40 million doses if they check out in trials. 

There is no approved COVID-19 vaccine, but governments across the world are busy signing deals with developers to gain access should trial results check out. 

The announcements came as the scientific community held its breath waiting for news of a potential vaccine from AstraZeneca and Oxford University, with trial results due to be published by The Lancet medical journal. 

According to the latest estimates from the World Health Organization there are 23 potential vaccines in clinical trials and 140 in preclinical development. 

The UK has secured 30 million doses of an experimental vaccine from BioNTech/Pfizer, and a deal in principle for 60 million doses of another vaccine from Valneva with an option of 40 million more doses if trials show it to be safe and effective. 

Later this month BioNTech and Pfizer are due to begin phase 2b/3 development of a vaccine candidate selected from four in early clinical trials. 

France’s Valneva said the vaccine could be manufactured at its facility in Livingston, Scotland, and in Solna, Sweden. 

Financial details were not disclosed. 

The deals follow a previously announced agreement with AstraZeneca for 100 million doses of the vaccine being developed in partnership with the University of Oxford. 

The AZ/Oxford vaccine is one of the most advanced in clinical development, with a phase 3 trial ongoing and results from a phase 1 trial due very soon. 

The government has also helped to fund a coronavirus vaccine developed by a team at London’s Imperial College, which is in an early clinical trial. 

GSK announces vaccine tie-up with CureVac 

GlaxoSmithKline separately announced a strategic collaboration with Germany’s CureVac to collaborate on mRNA vaccine and monoclonal antibody research in infectious diseases. 

The deal will not include CureVac’s COVID-19 vaccine, but will see the UK pharma make an equity investment of £130 million ($161 million) and an up front payment of £104 million ($129 million). 

CureVac will be eligible to receive development and regulatory milestone payments of up to £277m ($343 million), commercial milestone payments of up to £329m ($408 million) and tiered royalties on product sales.   

The agreement for the research, development, manufacturing and marketing of up to five mRNA-based vaccines and monoclonal antibodies targeting infectious disease pathogens. 

The companies said they will combine their knowledge of mRNA technology to develop vaccines against infectious diseases. 

Although the technology is not yet proven, many of the COVID-19 vaccines are based around mRNA technology that tells the body to produce antigens expressed by a virus. 

This in turn produces an immune response, and RNA vaccines have the advantage of being faster and cheaper to produce than with older techniques, allowing companies to respond quickly to emerging diseases. 

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PharmaShots Weekly Snapshot (Jul 13- 17, 2020)

 1.  Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis

Published: Jul 17, 2020 | Tags: Eli Lilly, Reports, Results, Mirikizumab, P-III, OASIS-2, Study, Treat, Moderate, Severe, Plaque Psoriasis

2.  Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced / Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid Tumors

Published: Jul 16, 2020 | Tags: Oncorus, Initiates, P-I, ONCR-177, Patients, Advanced, Refractory, Cutaneous, Subcutaneous, Metastatic, Nodal Solid Tumors

 3. Thermo Fisher Scientific Amends its Agreement to Acquire QIAGEN

Published: Jul 16, 2020 | Tags: Thermo Fisher Scientific, Amends, Agreement, Acquire, QIAGEN

4.  Kiniksa’s Rilonacept Receives the US FDA’s Orphan Drug Designation to Treat Pericarditis

Published: Jul 16, 2020 | Tags: Kiniksa, Rilonacept, Receives, US, FDA, Orphan Drug Designation, Treat, Pericarditis

5. Merck KGaA Takes an Early Option in its Existing Immuno-Oncology Collaboration with F-star

Published: Jul 17, 2020 | Tags: Merck KGaA, Takes, Early Option, Existing, Immuno-Oncology, Collaboration, F-star

6. Kronos Bio to Acquire Gilead’s SYK Inhibitor Portfolio

Published: Jul 17, 2020 | Tags: Kronos Bio, Acquire, Gilead, SYK Inhibitor, Portfolio, Entospletinib, Lanraplenib

7.  Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF

Published: Jul 16, 2020 | Tags: Merck, Bayer, Receive, US, FDA, Priority Review, Vericiguat, Reduce, Risk, CV Death, Patients, Symptomatic Chronic Heart Failure, HFrEF

8.  MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer

Published: Jul 15, 2020 | Tags: MSD, Collaborates, Novocure, Evaluate, Tumor Treating Fields, Together, Keytruda, pembrolizumab, Non-Small Cell Lung Cancer

9. Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India

Published: Jul 15, 2020 | Tags: Zydus, Initiates, Adaptive, P-I/II, Clinical Study, Evaluating, ZyCoV-D, Against, COVID-19, India

10.  NCCN Collaborates with Pfizer to Explore Adoption of Biosimilars in Oncology

Published: Jul 16, 2020 | Tags: NCCN, Collaborates, Pfizer, Explore, Adoption, Biosimilars, Oncology

11.  AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack

Published: Jul 16, 2020 | Tags: AstraZeneca, Report, Results, Brilinta, ticagrelor, P-III, THALES Study, Patients, Acute Ischemic Stroke, Transient Ischemic Attack

12.  Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Published: Jul 16, 2020 | Tags: Novartis, Launches, Zero Profit, Portfolio, Symptomatic Treatment, COVID-19

13.  Medtronic to Acquire Medicrea to Boost its Spine Offerings

Published: Jul 15, 2020 | Tags: Medtronic, Acquire, Medicrea, Boost, Spine Offerings

14.   AstraZeneca and the University of Oxford to Share Positive News on its COVID-19 Vaccine Imminently

Published: Jul 15, 2020 | Tags: AstraZeneca, University of Oxford, Share, Positive News, COVID-19 Vaccine, Imminently

15.   GSK’s Belantamab Mafodotin Receives the US FDA Advisory Committee’s Recommendation to Treat Relapsed/Refractory Multiple Myeloma

Published: Jul 14, 2020 | Tags: GSK, Belantamab Mafodotin, Receives, US, FDA, Advisory Committee, Recommendation, Treat, Relapsed/Refractory, Multiple Myeloma

16.  3M Collaborates with MIT to Develop Paper-Based Diagnostic Test for COVID-19

Published: Jul 14, 2020 | Tags: 3M, Collaborates, MIT, Develop, Paper-Based, Diagnostic Test, COVID-19

17.  Samsung Biologics Signs Multi-Product Development and Manufacturing Agreement with ImmuneOncia

Published: Jul 15, 2020 | Tags: Samsung Biologics, Signs, Multi-Product, Development, Manufacturing, Agreement, ImmuneOncia

18.  Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July, 2020

Published: Jul 14, 2020 | Tags: Moderna, Anticipate, Initiate, Late-stage, COVID-19, Vaccine, Trial, 27 July, 2020

19.   Sanofi and MD Anderson Sign a Five-Year Pact to Expedite Oncology Research and Development

Published: Jul 14, 2020 | Tags: Sanofi, MD Anderson, Sign, Five-Year, Pact, Expedite, Oncology, Research, Development

20.  Merck Signs an Exclusive Agreement with Dewpoint Therapeutics to Develop Curative Treatment for HIV

Published: Jul 13, 2020 | Tags: Merck, Signs, Exclusive Agreement, Dewpoint Therapeutics, Develop, Curative Treatment, HIV

21.  Roche’s Mosunetuzumab Receives the US FDA’s Breakthrough Therapy Designation to Treat Relapsed or Refractory Follicular Lymphoma

Published: Jul 14, 2020 | Tags: Roche, Mosunetuzumab, Receives, US, FDA, Breakthrough Therapy Designation, Treat, Relapsed, Refractory, Follicular Lymphoma

22.  Roche Expands its Collaboration with Immunomedics to Evaluate Tecentriq Based Combination Therapy in Urothelial and Non-Small Cell Lung Cancers

Published: Jul 13, 2020 | Tags: Roche, Expands, Collaboration, Immunomedics, Evaluate, Tecentriq, Based, Combination Therapy, Urothelial, Non-Small Cell Lung Cancers

23.  Roche Signs a ~$1B Agreement with Blueprint Medicines for its Precision Therapy to Treat Patients with RET-Altered Cancer Indications

Published: Jul 14, 2020 | Tags:  Roche, Signs, ~$1B, Agreement, Blueprint Medicines, Precision Therapy, Patients, RET-Altered, Cancer Indications

24. Paige Secures Funding from Goldman Sachs to Continue Innovation in Digital Pathology

Published: Jul 13, 2020 | Tags: Paige, Secures, Funding, Goldman Sachs, Continue, Innovation, Digital Pathology

25.   Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms

Published: Jul 10, 2020 | Tags: Gilead, Veklury, remdesivir, Receives, the TGA, Approval, Treat, Adults, Adolescent, Severe, COVID-19 Symptoms

26.   Pfizer with its Partner BioNTech Receives the US FDA’s Fast Track Designation for Two mRNA Based Therapies to Treat COVID-19

Published: Jul 13, 2020 | Tags: Pfizer, Partner, BioNTech,, Receives, the US FDA, Fast Track Designation, Two, mRNA, Based, Therapies, Treat, COVID-19

25. Samsung Biologics Expands its Development Partnership with STCube for STM418

Published: Jul 13, 2020 | Tags: Samsung Biologics, Expands, Development, Partnership, STCube, STM418

26.   Roche’s Reports Results of Tecentriq in P-III IMagyn050 Study for Women with 1L Newly Diagnosed Advanced Stage Ovarian Cancer

Published: Jul 13, 2020 | Tags: Roche, Reports, Results, Tecentriq, P-III, IMagyn050 Study, Women, 1L, Newly, Diagnosed, Advanced, Stage, Ovarian Cancer

27.  Biocon’s ALZUMAb (Itolizumab) Receives the DCGI’s Approval for Emergency Use to Treat Patients with Moderate to Severe COVID-19

Published: Jun 11, 2020 | Tags: Biocon, ALZUMAb, Itolizumab, Receives, the DCGI, Approval, Emergency, Use, Treat, Patients, Moderate, Severe, COVID-19