Healthcare & Pharma and Nutrition
News and Reviews
The UK is set to face short-term delays in delivery of the Pfizer/BioNTech coronavirus vaccine as the pharmaceutical company upgrades its production capacity.
Pfizer is upscaling production at its plant in Puurs, Belgium, in efforts to produce more doses than originally planned for 2021 – temporarily reducing deliveries to all European countries.
Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria
Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment
Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, Advance Personalized Fertility Treatment
Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China
Published: Jan 15, 2020 | Tags: Henlius’, HLX15 (biosimilar, daratumumab), Receives, IND, Approval, Multiple Myeloma in China
Abbott to Launch NeuroSphere myPath App to Record Pain Relief in Chronic Pain Patients
Published: Jan 15, 2020 | Tags: Abbott, Launch, NeuroSphere myPath App, to Record Pain Relief in Chronic Pain Patients
Published: Jan 15, 2020 | Tags: Pfizer’s, Xalkori (crizotinib), Receives, US FDA’s, Approval, ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult
Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies
Published: Jan 15, 2020 | Tags: Takeda, KSQ, Collaborate, Develop, Commercialize, Novel Immuno-Oncology Therapies
Published: Jan 14, 2020 | Tags: BeiGene, Tislelizumab, (BGB-A317), CT, Receive ,NMPA, Approval ,1L Therapy, Advanced Squamous NSCLC
Sanofi Signs a License Agreement with Biond for BND-22
Published: Jan 14, 2020 | Tags: Sanofi, Signs, License Agreement, Biond, BND-22
Celltrion Report Results of CT-P59 in P-II/III Study for COVID-19
Published: Jan 14, 2020 | Tags: Celltrion, Report, Results, CT-P59, P-II/III, Study, COVID-19
Published: Jan 14, 2020 | Tags: ViiV Healthcare, Tivicay, dolutegravir, dispersible tablets, Receives, EMA, Approval, Children, HIV
Amgen Collaborates with Evoq to Develop Novel Therapies for Autoimmune Disorders
Published: Jan 14, 2020 | Tags: Amgen, Collaborates, Evoq, Develop, Novel Therapies, Autoimmune Disorders
Kamada to Commercialize Three Biosimilar Products in Israel
Published: Jan 14, 2020 | Tags: Kamada, Commercialize, Three Biosimilar, Israel
Published: Jan 13, 2020 | Tags: US, Government, Purchase, Additional Doses, Regeneron, Casirivimab, Imdevimab, COVID-19
Teladoc Health and Dexcom Offers CGM-Powered Insight for T2D
Published: Jan 13, 2020 | Tags: Teladoc Health, Dexcom, Offers, CGM-Powered, T2D
UCB Launches Nile AI as a Digital Health Company to Transform the Course of Epilepsy
Published: Jan 13, 2020 | Tags: UCB, Launches, Nile AI, Digital Health Company, Transform, Course of Epilepsy
Bayer Reports the US FDA’s Acceptance of NDA and Grants Priority Review for Finerenone (BAY 94-8862) to Treat CKD and T2D
Published: Jan 13, 2020 | Tags: Bayer, Reports, US, FDA, Acceptance, NDA, Priority Review , Finerenone, (BAY 94-8862), CKD, T2D
Gilead Collaborates with VIR to Evaluate Combination Therapy for Chronic Hepatitis B Virus
Published: Jan 13, 2020 | Tags: Gilead, Collaborates, VIR, Evaluate, Combination Therapy, Chronic Hepatitis B Virus
GSK and VIR Biotechnology to Evaluate VIR-7832 in the Early Treatment of COVID-19
Published: Jan 12, 2020 | Tags: GSK and VIR, Biotechnology, Evaluate, VIR-7832, Early Treatment, COVID-19
Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC
Published: Jan 12, 2020 | Tags: Roche, Reports, Updated OS Data, Tecentriq, Avastin, P-III, IMbrave150 Study, Unresectable HCC
AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer
Published: Jan 12, 2020 | Tags: AstraZeneca, Collaborates, Adaptive, Mapping, Immune Response, Cancer
Bluebird bio to Spin Off its Oncology Business into Independent Company
Published: Jan 12, 2020 | Tags: Bluebird bio, Spin Off, Oncology Business, Independent Company
Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio
Published: Jan 12, 2020 | Tags: Novartis, In-Licenses, BieGene, Tislelizumab, Oncology Portfolio
Biogen and Apple Collaborate to Launch Virtual Study on Cognitive Decline
Published: Jan 12, 2020 | Tags: Biogen, Apple, Collaborate, Launch, Virtual Study, Cognitive Decline
BMS Collaborates with ArsenalBio to Advance Next-Generation T cell Therapies for Solid Tumors
Published: Jan 11, 2020 | Tags: BMS, Collaborates, ArsenalBio, Advance, Next-Generation, T cell Therapies, Solid Tumors
Chi-Med and Inmagene Collaborate to Develop Therapies for Immunological Diseases
Published: Jan 11, 2020 | Tags: Chi-Med, Inmagene, Collaborate, Immunological Diseases
Sanofi to Acquire Kymab for ~$1.45B
Published: Jan 11, 2020 | Tags: Sanofi, Acquire, Kymab, ~$1.45B
BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A
Published: Jan 11, 2020 | Tags: BioMarin, Reports, Results, Valoctocogene Roxaparvovec, P-III, GENEr8-1 Study, Hemophilia A
Roche’s Xofluza Receives the EC’s Approval for the Treatment of Influenza
Published: Jan 11, 2020 | Tags: Roche, Xofluza, Receives, EC, Approval, Treatment, Influenza
AbbVie Reports Results of Skyrizi (risankizumab) in P-III Induction Studies for Crohn’s Disease
Published: Jan 11, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (risankizumab), P-III, Induction Studies, Crohn’s Disease
Related Post: PharmaShots Weekly Snapshot (Jan 4-8, 2020)
The post PharmaShots Weekly Snapshots (Jan 11 – 15, 2021) first appeared on PharmaShots.
J&J 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.
The post J&J single-shot COVID-19 vaccine shows early promise appeared first on .
Sanofi Launches Tetraxim (DTaP-IPV) for Preschoolers in India
Date – Oct 01, 2020
Product – Tetraxim
Date – Oct 08, 2020
Product – Palynziq (pegvaliase-pqpz)
Date – Oct 08, 2020
Product – Skyrizi (risankizumab)
Regeneron Seeks the US FDA’s EUA for REGN-COV2 Antibody Combination to Treat COVID-19
Date – Oct 09, 2020
Product – REGN-COV2
Date – Oct 29, 2020
Product – BI 764198
Date – Oct 30, 2020
Product – Tecentriq + Avastin
Date – Oct 30, 2020
Product – Keytruda
Date – Oct 30, 2020
Product – Tremfya
Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19
Date – Nov 02, 2020
Product- BNT162b2
AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M
Date – Nov 02, 2020
Product- Crestor
Date – Nov 02, 2020
Product- 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)
Date – Nov 03, 2020
Product – FPI-1434
Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration
Date – Nov 03, 2020
Product- HMR59
Date – Nov 04, 2020
Product- Deucravacitinib
Date – Nov 04, 2020
Product- amivantamab
Merck to Acquire VelosBio for $2.75B
Date – Nov 05, 2020
Product- VLS-101
Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design
Date – Nov 05, 2020
Product- N/A
Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19
Date – Nov 05, 2020
Product- NVX-CoV2373
Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020
Date – Nov 07, 2020
Product- Hemlibra
Celltrion Reports Results of CT-P59 in P-I Study for COVID-19
Date – Nov 09, 2020
Product – CT-P59
AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia
Date – Nov 10, 2020
Product- Calquence (obinutuzumab)
Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens
Date – Nov 12, 2020
Product- Abrocitinib
UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio
Date – Nov 13, 2020
Product – Handl Therapeutics
Henlius report the NMPA’s Acceptance of HLX15(biosimilar, Daratumumab) to treat multiple myeloma
Date – Nov 16, 2020
Product- HLX15
Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2
Date – Nov 20, 2020
Product- BNT162b2
AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19
Date – Nov 23, 2020
Product – AZD1222
Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer
Date – Dec 15, 2020
Product- Cobas PIK3CA Mutation Test
Abbott’s COVID-19 IgG Quantitative Antibody Blood Test Receives CE Mark
Date – Dec 16, 2020
Product- SARS-CoV-2 IgG II Quant test
Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine
Date – Dec 15, 2020
Product- COVID-19 vaccine
Related Post: PharmaShots’ Key Highlights of Third Quarter 2020
The post PharmaShots’ Key Highlights of Fourth Quarter 2020 first appeared on PharmaShots.
Second shots of coronavirus vaccine could be delayed even further amid growing evidence that spacing out the doses improves their effectiveness.
The NHS vaccination programme aims to immunise about 14 million people at greatest risk of Covid by mid-February with second doses due to be given up to 12 weeks later.
Related: Vaccine supply is holding back jabs programme, says Matt Hancock
Australia’s chief medical officer Professor Paul Kelly and infectious diseases experts have defended securing 54m doses of a Covid-19 vaccine made by Oxford University and pharmaceutical company AstraZeneca, amid concerns the vaccine will not be effective enough to achieve herd immunity.
The president of the Australian and New Zealand Society for Immunology, Prof Stephen Turner, told Nine media that Australia should halt the AstraZeneca vaccine rollout because it has “lower efficacy”.
Related: Australia’s Covid vaccines: everything you need to know
The choice we have is not whether to use one or the other, it is whether to use what we have
Related: ‘How dare you leave’: confusion remains for some Victorians stranded interstate
The European medicines Agency (EMA) said this morning it has received a marketing application from AstraZeneca for its COVID-19 vaccine, already rolling out in the UK, and could give it the go-ahead later this month.
The filing for conditional marketing approval is scheduled for review by the EMA’s CHMP human medicine committee at a meeting on 29 January, and if all goes well it could be authorised on that day, according to the regulator.
The European Commission will then fast-track its decision-making process, says the EMA, with a view to granting a conditional marketing authorisation “within days”, a timeframe which was welcomed by Commission President Ursula von der Leyen.
AZ’s AZD1222 shot – which was developed with Oxford University – was cleared by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on 30 December, and since then it has also been given emergency approval in several other countries including India.
The filing comes as the EU is facing criticism for the slow roll-out of its coronavirus vaccination programme as infection rates soar in the 27 member states.
While individual EU countries make the decisions about who to vaccinate, the Commission is coordinating the acquisition and allocation of supplies, and there have been complaints the process is taking too long.
The US and Britain have both vaccinated 1%-2% of their populations, according to an Economist report citing figures from the Our World in Data website, while Israel is leading the field at 16%. In contrast, Germany has managed just 0.4%, France didn’t cross the 1,000 threshold until 4 January, and the Netherlands only started vaccinating until 6 January.
So far the EMA has conditionally approved two coronavirus vaccines – Pfizer/BioNTech’s Comirnaty last month and Moderna’s candidate last week – and swift approval of the AZ vaccine should allow an acceleration in vaccination rates in the EU.
As it stands, the UK has vaccinated more people than the entirety of the EU combined, with the latest government figures indicating 2.3 million people have now received the first of two required doses, saying it plans to immunise all adults in the country by the autumn.
So far the effect of vaccination is imperceptible, however, as the UK recorded more than 46,000 new cases of COVID-19 yesterday, and 529 deaths, with NHS capacity creaking under the weight of over 32,000 people hospitalised with the infection.
The EU has 400 million doses of the AZ vaccine on order, part of a procurement programme that so far extends to 2.3 billion doses.
Last week the Commission said it intended to order an additional 200 million doses of the BioNTech/Pfizer, with the option to acquire another 100 million doses, taking its total to 600 million doses.
It has also agreed deals for the supply of 160 million doses of the Moderna shot, 400 million apiece for candidates in testing at Johnson & Johnson and CureVac, and 300 million of a Sanofi/GlaxoSmithKline candidate that has been delayed by clinical trial snags.
The post EMA says AstraZeneca’s COVID-19 shot could be approved on 29 January appeared first on .
Click here to read full press release/ article | Ref: Adaptive | Image: Glassdoor
The post AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer first appeared on PharmaShots.
Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes.
The US regulator is looking at data from the EMPEROR-Reduced trial of Jardiance (empagliflozin), which found that the drug achieved a 25% reduction in the combined primary endpoint of cardiovascular death or hospitalisation compared to placebo.
Lilly and Boehringer claim almost 60% market share for Jardiance among SGLT2 drugs used to treat type 2 diabetes, driving blockbuster sales for the brand.
It was the top-selling drug in the SGLT2 inhibitor class in 2019, with sales of almost $3 billion, helped by side-effect problems that have afflicted first-to-market rival Invokana (canagliflozin) from Johnson & Johnson.
However its rivals – which also include AstraZeneca’s Farxiga (dapagliflozin) – have moved more swiftly into areas like heart failure and chronic kidney disease (CKD) which have made large numbers of new patients eligible for treatment with the class.
The new FDA review – covering Jardiance as a treatment for adults with heart failure with reduced ejection fraction (HFrEF) in patients with and without diabetes – is Lilly and Boehringer’s first chance to fight back.
Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million. AZ picked up EU approval for the same indication the following November.
Lilly and Boehringer will be hoping for a swift FDA review so that Jardiance will not fall too far behind its competitor in the heart failure category, and that looks likely as the benefit in HFrEF increasingly appears to be an SGLT2 class effect.
GlobalData has said that heart failure could add billions to the sales of the two SGLT2 inhibitors, particularly if they also claim approvals in heart failure with preserved ejection fraction (HFpEF), a larger patient population.
It says Farxiga will reach peak sales of $9 billion in 2028, with Jardiance forecast to reach $4.6 billion, assuming a launch for HFrEF this year. The bulk of those sales will come from HFpEF, however, as in this form of heart failure there is a huge unmet need and no approved therapies.
Boehringer and Lilly are waiting for the results of the EMPEROR-Preserved later in 2021, while AZ should also Farxiga in the DELIVER trial in HFpEF, with additional data on both HFrEF and HFpEF due from the DETERMINE study, before year-end.
Meanwhile, EMPEROR-Reduced also showed a slowdown in the rate of decline in kidney function among patients with HFrEF, an effect that Lilly and Boehringer are exploring in the CKD patient population in the EMPA-KIDNEY trial due to generate results in 2022.
Invokana was the first mover among the SGLT2 drugs in the kidney area, winning FDA approval towards the end of 2019 for diabetic kidney disease. After a couple of years of declining sales due to concern about a risk of lower limb amputation, Invokana managed a 25% gain to $224 million in third-quarter 2020.
Farxiga meanwhile has already been filed for CKD on the back of the DAPA-CKD trial, with a verdict due in the second quarter.
The post Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label appeared first on .
Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies
Published: Jan 7, 2020 | Tags: Sarepta, Reports, Mixed Results, SRP-9001, (rAAVrh74.MHCK7.micro-dystrophin), Part 1, Study 102, DMD
PerkinElmer to Acquire Oxford Immunotec for ~$591M
Published: Jan 7, 2020 | Tags: PerkinElmer, Acquire, Oxford Immunotec, ~$591M
Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD
Published: Jan 7, 2020 | Tags: Pfizer, Reports, First, Patients, Dosing, of PF-06939926 in P-III CIFFREO Study for DMD
Published: Jan 7, 2020 | Tags: Alnylam, Reports, Results, Vutrisiran, P-III, HELIOS-A, Study, Patients, hATTR Amyloidosis, Polyneuropathy
Bayer Collaborates with CureVac for CVnCoV Against COVID-19
Published: Jan 7, 2020 | Tags: Bayer, Collaborates, CureVac, CVnCoV, Against, COVID-19
Hologic to Acquire Biotheranostics for ~$230M
Published: Jan 7, 2020 | Tags: Hologic, Acquire, Biotheranostics, ~$230M
Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology
Published: Jan 6, 2020 | Tags: Pfizer, Signs, License, Supply, Agreement, ImaginAb, CD8 ImmunoPET Technology
Published: Jan 6, 2020 | Tags: Merck KGaA, Acquires, AmpTec, Strengthen, mRNA, Capabilities, Vaccines, Treatments, Diagnostics
Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies
Published: Jan 6, 2020 | Tags: Genentech, Signs, ~$1B, Pact, Ribometrix, Develop, RNA-Targeted, Small Molecule Therapies
Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy
Published: Jan 6, 2020 | Tags: Astellas, Reports, US, FDA, Acceptance, Priority Review, NDO Therapy, Myrbetriq, mirabegron, tablets, oral suspension
Pfizer Collaborates with Dewpoint to Develop Therapies for Rare Form of Muscular Dystrophy
Published: Jan 6, 2020 | Tags: Pfizer, Collaborates, Dewpoint, Develop, Therapies, Rare Form of Muscular Dystrophy
Nirmidas Receives the US FDA’s EUA for its COVID-19 Rapid Antibody Fingerstick Test
Published: Jan 6, 2020 | Tags: Nirmidas, Receives, US, FDA, EUA, COVID-19, Rapid, Antibody, Fingerstick Test
Published: Jan 6, 2020 | Tags: AstraZeneca, Farxiga, (dapagliflozin), Receives, US, FDA, Priority Review, Chronic Kidney Disease
AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis
Published: Jan 5, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (Risankizumab), P-III, Studies, Active Psoriatic Arthritis
Regenxbio Reports the Initiation of First Pivotal Program for RGX-314 to Treat Wet AMD
Published: Jan 5, 2020 | Tags: Regenxbio, Provide, Update, RGX-314, Treat, Wet AMD, RGX-202
Evotec Receives Milestones in its Neurodegeneration Collaboration with BMS
Published: Jan 5, 2020 | Tags: Evotec, Bristol Myers Squibb, $6M, Milestones
Stryker Acquires OrthoSensor and its Knee Surgery Sensor Technology
Published: Jan 5, 2020 | Tags: Stryker, Acquires, OrthoSensor, Knee Surgery Sensor Technology
Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development
Published: Jan 4, 2020 | Tags: ViGeneron, Signs, Global License Agreement, Biogen, Ophthalmic Gene Therapy, Development
Published: Jan 4, 2020 | Tags: Y-Biologics, signed, License Agreement, 3D Medicines, Develop, Manufacture, Commercialize, YBL-013
Published: Jan 4, 2020 | Tags: aTyr Pharma, Report, Positive Results, ATYR1923, P-ll Study, COVID-19
Published: Jan 5, 2020 | Tags: Genentech, Tiragolumab + Tecentriq, Receives, US FDA’s, Breakthrough Therapy Designation, PD-L1-High Non-Small Cell Lung Cancer
Published: Jan 4, 2020 | Tags: Pfizer, OPKO, Reports, US FDA, Acceptance, BLA, Somatrogon, Treat, Growth Hormone Deficiency (GHD)
Hologic to Acquire Somatex for ~$64 M
Published: Jan 4, 2020 | Tags: Hologic, Acquire, Somatex, $64 M
Published: Jan 3, 2020 | Tags: Provention Bio, Reports, Submission, BLA, Priority Review, US, FDA, Teplizumab, Prevent, T1D
Oura Ring Monitors Body Temperature and Identify Early COVID-19 Symptoms
Published: Jan 2, 2020 | Tags: Oura Ring Monitors, Body Temperature, Identify, Early, COVID-19, Symptoms
Tiziana Completes Clinical Trial of Nasally Administered Foralumab for COVID-19 in Brazil
Published: Jan 3, 2020 | Tags: Tiziana, Completes, Clinical Trial, Nasally, Administered, Foralumab, COVID-19, Brazil
Antengene Reports NDA Submission for ATG-010 (Selinexor) to Treat RRMM and RR DLBCL in South Korea
Published: Jan 3, 2020 | Tags: Antengene, Reports, NDA, Submission, ATG-010, (Selinexor), RRMM, RR DLBCL, South Korea
AstraZeneca’s COVISHIELD Receives EUA in India for COVID-19
Published: Jan 4, 2020 | Tags: AstraZeneca, COVISHIELD, Receives, EUA in India
RedHill Reports Results of Yeliva (opaganib) in P-II Study for COVID-19
Published: Jan 3, 2020| Tags: RedHill, Reports, Results, Yeliva, (opaganib), P-II, Study, COVID-19
Related Post: PharmaShots Weekly Snapshots (Dec 28- 31, 2020)
The post PharmaShots Weekly Snapshot (Jan 4-8, 2020) first appeared on PharmaShots.
As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses.
When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.
After months of turbulent lockdown measures, the dawn of approved vaccinations signalled hope COVID-19 could finally be under control.
Sadly, the chaos is continuing as the UK grapples with the emergence of a new variant of SARS-CoV-2, estimated to be up to 70% more transmissible than the previous form of the virus.
As cases surge, the UK’s decision to delay second doses of the vaccine beyond the 3-4 weeks tested and approved during Phase III clinical trials is causing widespread concern. Many believe the strategy is too risky – prioritising political expediency over science and using the British public as laboratory subjects during an already severe crisis.
The advice, which first came from the UK’s Joint Committee on Vaccination and Immunisation (JCVI), stated a maximum interval of 12 weeks should take place between the first and second doses of both Pfizer and AstraZeneca’s vaccines.
JCVI said this is likely to have a greater public health impact in the short term and reduce the number of preventable deaths from COVID-19.
“The rate of vaccine delivery in the UK is currently limited by vaccine supply rather than by workforce capacity,” said the committee. “An extended interval between vaccine doses together with initial prioritisation of the first vaccine dose would increase the flow of vaccine supply in the short term. This will allow for more first doses to be delivered to more people earlier.”
The advice has been endorsed by the UK’s four chief medical officers but has been met with backlash from the medical community. Many healthcare workers have aired grievances on Twitter protesting the changes.
The British Medical Association (BMA) also blasted the decision as “unreasonable and totally unfair”.
“The Government must see that it’s only right that existing bookings for the oldest and most vulnerable members of our society are honoured, and it must also as soon as possible publish a scientifically-validated justification for its new approach,” said the BMA.
“As doctors, we believe this can and should be done even as practices and the wider NHS step up the COVID-19 vaccination programme to deliver initial doses of vaccination to other vulnerable people, including frontline healthcare professionals – many of whom still have not even received their first vaccination.”
‘Erosion of public trust’’
The NHS Confederation, which represents leaders across the organisation, told pharmaphorum the government needed to be very clear in its communications with the public about exactly what they are being asked to do and why.
“We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorised dosing schedule for each COVID-19 vaccine”
“Protecting frontline staff from infection is vital to help them care for patients with COVID, as well as delivering the vaccination programme,” said NHS Confederation director Layla McCay. “However, there has been concern about changes to the vaccination schedule, which were announced at short notice and led to confusion and anxiety for patients and could lead to an erosion of public trust in healthcare providers. As always, NHS teams will pull out all the stops to respond to changing guidance, but the government must do more to explain the rationale for this change.”
Internationally, the decision has been met with scepticism. The FDA issued a statement regarding dosing schedules on 4 January 2021. “We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccines to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.
“We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.”
In a joint statement Pfizer and BioNTech warned there was no data to demonstrate that protection after the first dose is sustained after 21 days. “The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design,” said the companies.
Industry support
The Oxford-AstraZeneca vaccine trial did include difference spacing between doses and showed longer gaps (two to three months) yielded a greater immune response. The combined trial results published in the Lancet showed that vaccine efficacy 14 days after a second dose was higher in the group that had more than six weeks between the two doses (65.4%) than in the group that had less than six weeks between doses (53.4%).
Andrew Pollard, head of the Oxford Vaccine Group and chief trial investigator vaccine told the BMJ that extending the gap between doses made sense.
“Generally, a longer gap between vaccine doses leads to a better immune response, with the second dose causing a better boost. (With HPV vaccine for girls, for example, the gap is a year and gives better responses than a one-month gap.) From the Oxford vaccine trials, there is 70% protection after the first dose up to the second dose, and the immune response was about three times greater after the second dose when the second dose was delayed, comparing second dose after four weeks versus second dose after two-three months.”
Akiko Iwasaki, professor of immunobiology at Yale Medical school also tweeted support for the changes, stating the new SARS-CoV-2 variant as the deciding factor.
“I am still a proponent of two-dose vaccine but given the urgency, we can delay the seconnd dose until more vaccines become available. I know many others have been saying this all along, but it was the B.1.1.7 variant transmission rate that did it for me,” said Iwasaki.
David Grainger, chief scientific advisor at life sciences investment firm Medicix, also expressed confidence in the strategy, referring to modelling by the University of Toronto that predicts increasing the number of people protected, by limiting individuals to a single dose, reduces severe COVID events (ICU stays and death) by between 30-40% over a 6-month period. This could amount to over 20,000 lives saved.
“The vaccine only must be 50% effective in two people to reduce the overall risk of infection that is achieved with 95% protection in one person,” said Grainger. “If I protect 10,000 people out of a population of 20,000 with 1% risk of infection at 95% efficacy, I get five cases from the protected subgroup and 95 cases in the unprotected subgroup for a total of 100 infections; if I protect all 20,000 people with 50% efficacy, again I get 100 infections. The existing data strongly suggests that a single dose will deliver at least 50% protection for at least a few months.”
He added that during the pandemic, decisions often needed to be made in the absence of proper data. “It teaches us that we cannot just ‘follow the science’ because that pathway is way too conservative (at least if that means only do things for which there is clear, direct evidence).
“This is why we should have scientific advisors, but not rely on scientists to make decisions. It is why scientists rarely make good investors or businessmen – too many decisions need to be made in the absence of much information.”
The post Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy appeared first on .
The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules.
With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to bring the virus under control.
The UK is in a national lockdown that could last into March, with more than 62,000 new cases and 1,000 coronavirus-related deaths recorded yesterday as a more transmissible strain threatens to overwhelm the country’s health service.
As things stand, the two rival mRNA-based vaccines from Pfizer/BioNTech and Moderna are now approved for use in the EU.
Meanwhile in the UK, the Pfizer/BioNTech and AstraZeneca shots have been quickly approved.
The UK government has an order for just 7 million shots of the Moderna vaccine covering just half a percent of the population, while the European Commission has secured 160 million doses, enough to cover around 18% of the population.
US-based Moderna said that first deliveries of the vaccine in Europe will begin next week.
Moderna’s vaccine is arguably the most effective approved so far at around 95%, while AstraZeneca’s rival that has been swiftly approved in the UK ahead of Europe works in around 62% of cases when given its recommend dose.
The Pfizer/BioNTech seems to be of comparable efficiency to the Moderna shot, and is being rolled out across the UK along with the AZ vaccine.
There is evidence to suggest the AZ vaccine’s efficacy could be improved to 90% by giving a half-dose to start with, but UK regulators have not been given sufficient evidence to approve this formulation.
After a rolling review began of Moderna’s vaccine late last year, the European Commission has issued a conditional marketing authorisation the day after it was backed by regulators from the CHMP scientific committee.
Moderna has said it is in talks with the UK regulator over approval, where European Commission decisions on medicines no longer automatically apply because of Brexit.
Under Brexit transition arrangements the Medicines and Healthcare products Regulatory Authority (MHRA) will continue to adopt decisions by the European Commission on medicines.
In usual circumstances companies are required to submit an identical filing request to the MHRA after a CHMP positive opinion
The UK regulator would then follow the decision of the European Commission, which nearly always rubber-stamps the CHMP’s decision within a few weeks.
But on this occasion the process has not been possible because of the accelerated timelines for vaccine approval because of the pandemic.
Questioned by pharmaphorum, the MHRA was unable to comment on arrangements for the Moderna vaccine at the time of writing.
However Moderna said separately that it is in talks with the MHRA to get the vaccine approved.
The post UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine appeared first on .
Everything now hinges on a vaccine: how many more Britons die, whether the NHS finally breaks, how long the UK stays locked down. All depends on how fast the country can get vaccinated against this plague. Yet we’re in this position in large part because of government failure. When the prime minister imposes lockdowns late and with a sulky grumble; when we haven’t fixed our £22bn test-and-trace system (which, by the way, now bankrolls more outside consultants and contractors than the Treasury has actual civil servants); and when the Dominics and Stanleys are allowed to carry on as if rules are for the little people. If Boris Johnson blunts every political instrument he can lay his pale and meaty hands on, pretty soon a syringe is the only resort.
Vaccines were always going to be how the world limped out of this pandemic; but as Taiwan and New Zealand show, even without inoculation it is possible to drive the number of Covid cases significantly down. Compare their record with the UK – which is on course to hit 100,000 Covid-related deaths before January is out, and where a staggering one in 30 Londoners is today infected. The lecterns from which Johnson and his top advisers gave their press conference this week read “Stay Home. Protect the NHS. Save Lives” – exactly as they did at the start of all this last March, as if to confirm how little progress they have made in almost a year.
Related: For mRNA vaccines, we should stick to the schedule | Angela Rasmussen and Ilan Schwartz
The UK government has promised a “massive uplift” in the number of coronavirus vaccinations carried out this week, while conceding a target of 13.9 million jabs offered by the end of February will be “challenging”.
As the number of daily recorded cases in the country exceeded 60,000 for the first time, vaccine minister Nadhim Zahawi told BBC Radio 4’s today programme: “My absolute focus is to get to 13.9 million…offered a vaccine by the middle of February.
“That is my target and I’m confident the NHS has a plan and we will meet that target.”
The number of vaccinations will continue to rise, he promised, adding that a quarter of over-80s had already been vaccinated.
Zahawi stopped short of saying when the government would reach the 300,000 vaccinations a day required to meet the goal.
More than a million people are thought to be infected with virus at the moment and hospitals across in the worst-affected areas are running at full capacity because of the disease.
All of the country is now in a strict lockdown, with mixing indoors banned and people instructed to stay except to get exercise and other essential tasks such as buying food.
According to reports elsewhere there are a number of backlogs that are causing delays to the roll-out of the vaccine from AstraZeneca, which will be offered to the majority of patients.
The UK has ordered 100 million doses of the vaccine and AZ has reportedly manufactured around 3.5 million doses in addition to the half million or so shots that are already available.
But Sky News reported that the extra doses are still waiting to be batch tested by the country’s regulator, the Medicines and Healthcare Products Regulatory Agency.
Sky reported that the MHRA is working in parallel with AstraZeneca’s own batch testing system to speed up a process that usually takes up to three weeks.
There are also issues with Pfizer/BioNTech vaccine, which is not manufactured in the UK like the AZ shot but in Belgium.
It has already been placed into glass vials by the time it arrives in the country, but a worldwide shortage of these means that five million doses have been delivered.
This is less than half the number that should have been because of the problems with manufacturing including the fill-and-finish process, according to the BBC.
Feature image courtesy of NIH/Rocky Mountain Laboratories
The post UK promises ‘uplift’ in COVID-19 vaccinations as crisis deepens appeared first on .
There is no scientific evidence for a delay of more than six weeks in administering the second dose of the Pfizer/BioNTech vaccine against Covid, say experts from the World Health Organization.
The UK is planning to postpone giving the second dose of both the Pfizer/BioNTech and the Oxford/AstraZeneca vaccines by up to 12 weeks – twice the length of time for which there is data, according to the WHO.
Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first doses of two approved shots.
The regulator made its comments after the UK announced a policy of stretching the gap between doses of the vaccine to up to 12 weeks to ensure maximum coverage of vulnerable groups.
The UK’s Joint Committee for Vaccines and Immunisation (JCVI) has recommended prioritising the first shot of the vaccines from Pfizer/BioNTech and AstraZeneca – but said that the follow-up booster dose can be delayed by up to 12 weeks.
According to the UK’s drug regulator the Pfizer/BioNTech vaccine doses should be taken at least 21 days apart while AZ vaccine’s booster doses should be given between four and 12 weeks apart.
But the FDA has issued a statement warning against such a strategy and reminded the public about the importance of receiving their second dose on time.
In the US, the Pfizer and BioNTech vaccine and a rival from Moderna is approved with a four-week gap between doses, but the AstraZeneca vaccine is not.
The FDA said it had been monitoring discussions and news reports about the policy and concluded that extending the time between doses, changing the dose and mixing and matching vaccines are “reasonable questions” to consider and evaluate.
But in a strongly-worded statement it said that changing the vaccine schedule without evidence could “undermine the historic vaccination efforts to protect the population from COVID-19.”
There are concerns elsewhere that the extended dosing schedule could also lead to resistant forms of the virus taking hold at a time when there is a new and highly infectious variant spreading through the UK.
In the US, doctors pointed out that the slow roll-out of the vaccines is due to logistical challenges rather than supply and urged authorities to focus on this rather than delaying the dosing schedule.
In the meantime, the UK government has pushed ahead with plans to vaccinate everyone in the four highest-priority groups by mid-February.
This will require the NHS to start delivering at least two million shots a week from next week.
AZ’s chief executive Pascal Soriot said it would be possible to manufacture the required vaccines, although it remains to be seen whether output will be increased in time to hit the target.
The government said it already has a batch of 530,000 doses and a further 450,000 are reportedly due to be available by the end of week according to Oxford University’s regius professor of medicine Sir John Bell.
Several million more doses of the vaccine are understood to have been manufactured but have not yet been bottled in vials.
The post FDA and doctors warn against extending COVID-19 vaccine dose gap appeared first on .
Click here to read full press release/ article | Ref: Hindustan Times | Image: The Economic Times
The post AstraZeneca’s COVISHIELD Receives EUA in India for COVID-19 first appeared on PharmaShots.
The UK is setting the pace around the world in the approval and use of Covid vaccines but, while other countries watch intently, not all are yet prepared to embrace what looks like public health pragmatism rather than strict adherence to evidence.
Britain is the first country in the world to approve and use the Oxford/AstraZeneca vaccine, just as it was first with Pfizer/BioNTech’s. In a further trailblazing decision, it is giving everyone a first shot of either of those vaccines, with the second shot delayed to 12 weeks afterwards instead of the three- or four-week interval in the trials.
The biggest vaccination programme in the UK’s history will receive a major boost on Monday, with the first use of the Oxford/AstraZeneca Covid vaccine. We answer some key questions around how it will be deployed in England.
Related: UK hospitals receive Oxford/AstraZeneca Covid vaccine for Monday rollout
People in Britain are set to get their first shots of the Oxford/AstraZeneca vaccine on Monday, with millions of doses being given over the next few months. The mass vaccination of the UK’s population should bring an end to the country’s Covid-19 misery, but how long will it take for this immunisation programme to make a difference to our lives – and what will be the first signs that salvation is on the way?
These key issues will be anxiously pursued as the battle against Covid proceeds and daily cases involving the new virus variant continue to spread. However, scientists have warned that simply waiting for a reduction in new cases it not the way to tell whether the vaccine is starting to have an impact.
Related: Symptomless cases in schools could be key driver in spread of Covid-19
Related: Why is Britain delaying second doses of Covid vaccines?
The Oxford/AstraZeneca vaccine is central to the government’s plans for ending social distancing in the UK and returning to some sort of normality. It has invested in seven different vaccines, but the biggest order is for 100m doses of the AstraZeneca jab, most of which will be manufactured in the UK. While the prime minister was jubilant that the UK was first in the world to approve the Pfizer/BioNTech vaccine, he is now able to claim a British triumph. More to the point is the ease of use of the AstraZeneca vaccine. Unlike Pfizer’s, it does not have to be kept in the long term at -70C. Pfizer’s vaccine can be stored in a fridge for five days, but AstraZeneca’s can be kept for months at fridge temperature, which is 2-8C and will be easy to take to care homes to administer to residents, the first priority group for vaccination.
Related: BioNTech criticises EU failure to order enough Covid vaccine
Related: World leaders urged to make Covid vaccine available to millions of refugees
Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, results, Sinopharm
Published: Dec 28, 2020 | Tags: CysticFibrosis, Drug, New, reports, Submission, Treatment, Trikafta, Vertex
The US FDA Grants EUA for Quanterix’s Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test
Published: Dec 29, 2020 | Tags: Emergency Use Authorization, Grants, Quanterix’s Simoa, Semi-Quantitative SARS-CoV-2 IgG Antibody Test, Us FDA
Sorrento Reports Submission of MAA to COFEPRIS for COVI-STIX Rapid Detection Test
Published: Dec 30, 2020 | Tags: COFEPRIS, Marketing Authorization Application, reports, Sorrento, Submission
Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine
Published: Dec 30, 2020 | Tags: AstraZeneca, Authorization, COVID-19, Health Canada, reports, Statement, UK, vaccine
Incyte Collaborates with Cellenkos for CK0804 to Treat Myelofibrosis
Published: Dec 30, 2020 | Tags: Cellenkos, CK0804, Development, Global, Incyte, License Agreement, Myelofibrosis, Signs
Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D
Published: Dec 24, 2020 | Tags: Clinical, Data, Nod, P-I/II, P-III, Seeks, Start, Submits, Trial, Trials, ZyCoV-D, Zydus Cadila
Published: Dec 29, 2020 | Tags: antibody, Cocktail, COVID-19, Data, Encouraging, flow, Hospitalized, Initial, Low, Oxygen, patients, Regeneron, reports, Trial
AstraZeneca’s AZD1222 Receives MHRA’s Emergency Supply Authorization in the UK
Published: Dec 30, 2020 | Tags: AstraZeneca, Authorization, AZD1222, Emergency, MHRA, receives, Supply, UK
Published: Dec 22, 2020 | Tags: Develop, Discover, License Agreement, Novel Small Molecules for Serious Diseases, Sign, Skyhawk, Strategic Research, Vertex
Published: Dec 29, 2020 | Tags: EMA, Label Extension, Novo Nordisk, reports, Semaglutide, Submission, T2D
Published: Dec 28, 2020 | Tags: Advanced, Chi-Med, Initiates, NDA, Neuroendocrine, Rolling, Submission, Surufatinib, Treat, Tumors, Us FDA
Alligator Bioscience Submits CTA for the P-II OPTIMIZE-1 Study of Mitazalimab
Published: Dec 28, 2020 | Tags: Alligator Bioscience, CTA, Mitazalimab, OPTIMIZE-1, P-II, study, Submits
Published: Dec 28, 2020 | Tags: Acceptance, Lorbrena (lorlatinib), Pfizer, Priority Review, Report, sNDA, treat (ALK)-Positive (NSCLC), US FDA’s
Biocon has Launched Tacrolimus Capsules in the US
Published: Dec 28, 2020 | Tags: Biocon, Launches, Tacrolimus Capsules, US
Published: Dec 28, 2020 | Tags: Agreement, Commercialize, Develop, health, Myovant, Oncology, Pfizer, Relugolix, Signs, Women
Published: Dec 28, 2020 | Tags: Amivantamab, EGFR Exon 20 Insertion Mutations, EMA, Janssen, MAA, Metastatic Non-Small Cell Lung Cancer, Report, Submission
Published: Dec 28, 2020 | Tags: CLN-081, Commercialization, Cullinan Oncology, Development, Exclusive License Agreement, Greater China, Signs, Zai Lab
Algernon’s Last Patient Out in NP-120 (Ifenprodil) P-IIb/III Study for COVID-19
Published: Dec 24, 2020 | Tags: Algernon, COVID-19, Ifenprodil, Last Patient Out, Multinational, P-IIb, P-IIb/III, reports
Published: Dec 24, 2020 | Tags: (CD19 CAR-T), Breakthrough Therapy Designation, BT Designation, Casi, CNCT19, NMPA, receives, Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Published: Dec 23, 2020 | Tags: Amyrt’s, AP103, Dystrophic Epidermolysis Bullosa (DEB), receives, Treatment, US FDA’s
Published: Dec 24, 2020 | Tags: Agreement, Aurobindo, Commercialize, COVAXX, COVID-19, Develop, India, Pharma, Sign, UB-612, UNICEF, vaccine
Innovent’s Byvasda (Bevacizumab Biosimilar) Receive NMPA’s Approval for Adult Recurrent Glioblastoma
Published: Dec 28, 2020 | Tags: Adult Recurrent Glioblastoma, approval, BYVASDA (Bevacizumab Biosimilar) Treatment, Innovent, NMPA
Published: Dec 23, 2020 | Tags: Adalimumab Biosimilar, Innovent, NMPA’s Approval, Non-infectious Uveitis, panuveitis in adults, Pediatric Plaque Psoriasis, posterior uveitis, Receive, Sulinno
Related Post: PharmaShots Weekly Snapshots (Dec 21-23, 2020)
The post PharmaShots Weekly Snapshots (Dec 28- 31, 2020) first appeared on PharmaShots.
2. Theramex to Acquire Commercial Rights of MSD’s Zoely to Expand its Footprints
3. Gilead Signs an Exclusive License Agreement with Rockefeller University for its Portfolio of HIV Abs
4. Fujifilm’s CAD EYE Receives CE Mark to Support the Detection of Colonic Polyp Utilizing AI in the EU
11. Amgen Signs a Partnership with Adaptive Biotechnologies to Develop Abs for COVID-19
12. BioNTech and Pfizer Complete Dosing of BNT162 in First Cohort of P-I/II Study in Germany
14. Neurocrine Biosciences Exercises its Option with Idorsia for ACT-709478
15. Moderna Signs a Ten-Year Worldwide Agreement with Lonza to Manufacture mRNA-1273 Against COVID-19
18. Sorrento Submits EUA to the US FDA for its COVI-TRACK Test to Detect COVID-19
21. Zydus Launches Cheapest Version of Remdesivir at $37.41 per Vial in India
22. Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B
29. UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio
30. Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration
Related Post: PharmaShots’ Most Read News of 2019
The post PharmaShots’ Most Read News of 2020 first appeared on PharmaShots.
Click here to read full press release/ article | Ref: Newswire Canada | Image: Money Control
The post Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine first appeared on PharmaShots.
It’s a pragmatic solution to an incredibly urgent problem – how to immunise very large numbers of people at risk from a rampaging variant of Covid-19 in the shortest possible time. The answer that government advisers have come up with is to give them all – more than 20 million of them – a single shot of the Oxford/AstraZeneca vaccine so that they have some protection and postpone the second dose to three months afterwards, when hopefully there will be plenty of vaccine available for boosters.
Related: How well does the Oxford vaccine work? What we know so far
Related: The vaccine miracle: how scientists waged the battle against Covid-19
The UK has approved AstraZeneca and Oxford University’s COVID-19 vaccine AZD1222 in another significant step forward in the fight against the pandemic, with first doses due to be administered on Monday.
The UK government has already ordered 100 million doses of the adenovirus-based shot, enough to vaccinate 50 million people, adding to the 40 million dose order of the Pfizer/BioNTech shot – now known as Comirnaty – that was approved earlier this month.
The UK is the first country to approved AZD1222, and AZ says it is preparing to provide “millions of doses” in the first quarter of 2021, while building capacity for three billion doses for delivery worldwide by the end of the coming year.
The emergency approval comes as millions more people in the UK are facing tighter lockdown restrictions after another daily record of more than 53,000 confirmed new coronavirus cases yesterday.
Health Secretary Matt Hancock warned that while the rollout of AZD1222 brings forward the end of the pandemic, mass vaccination will take time and people should “hold their nerve” to avoid swamping the NHS in the first few months of 2021.
He told the BBC this morning that he now has “a high degree of confidence that we can be out of this by the spring.”
The Joint Committee on Vaccine and Immunisation (JCVI) has set out priority groups who will receive the vaccine, and as with the Pfizer/BioNTech jab first in line will be the over-80s and health and social care workers. So far, more than 600,000 people have received Comirnaty since dosing started on 9 December.
AZ chief executive Pascal Soriot said that millions of doses of AZD1222 have already been produced and are being filled, ready to ramp up supply as the UK immunisation programme gathers pace.
Soriot confirmed that AZ should be able to provide enough vaccine to meet the UK government’s target of a million doses per week “very rapidly” with the first doses due to be delivered to clinics “today or tomorrow.”
He also said that AZD1222 provides a reasonable level of protection from the coronavirus after a single dose, and as the second dose only needs to be given within 12 weeks, that provides an opportunity to immunise more people, more quickly.
In turn, that should start to reduce mortality and hospitalisation from COVID-19 and ease pressure from the NHS as cases continue to surge.
The AZ vaccine can also be stored, transported and handled at normal refrigerated conditions for at least six months making it more suitable for delivery to parts of the world with less sophisticated healthcare systems than the Pfizer/BioNTech shot, which requires colder storage.
Soriot also reiterated his view that AZD1222 should provide protection against the new, more transmissible strain of the SARS-CoV-2 virus that causes COVID-19.
The first case of that has now been identified in the US, along with dozens of other countries, but new research suggests that while it is easier to transmit it isn’t any more likely to cause severe disease.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved two full doses of AZD122, which has a top-line protective efficacy of 62%, as it decided there wasn’t enough data on a half dose/full dose combination that seemed to be more effective in trials with 90% protection rate.
The British Medical Association’s council chair Dr Chaand Nagpaul, welcomed the approval, but warned the rollout will require a massive step up in immunisation capacity.
“It is now crucial that supplies of this vaccine are given to as many GP practice sites and hospital hubs as possible and that this happens as quickly as possible so that we can begin vaccination en masse,” he said.
“We need to see a step change in distribution so that doctors can protect their patients and communities, beginning with those most at risk, and crucially this must include health and social care workers as they confront the virus on the front line.”
The BMA has previously said it is concerned about patchy access to the Pfizer/BioNTech vaccine by healthcare workers across the country.
EU orders another 100m doses of Comirnaty
The EMA is still reviewing the AZ vaccine, but yesterday exercised an option to acquire another 100 million doses of Comirnaty for distribution in the EU in 2021, taking the tally to 300 million doses.
Pfizer and BioNTech say they will be able to meet that order, agreed just two days after the first vaccinations against COVID-19 started in EU member states. The companies have previously said they will be able to supply up to 1.3 billion doses worldwide by the end of 2021.
The post AZ COVID-19 vaccine cleared in UK, dosing to start next week appeared first on .
Click here to read full press release/ article | Ref: AstraZeneca | Image: Express Pharma
The post AstraZeneca’s AZD1222 Receives MHRA’s Emergency Supply Authorization in the UK first appeared on PharmaShots.
What You Should Know:
– Pfizer, AstraZeneca, Merck, and Teva, and Amazon Web Services (AWS) has been selected by the Israel Innovation Authority to establish an innovation lab in the fields of digital health and computational biology.
– The innovation lab located in the Rehovot Science Park will
receive a government budget of $10M over the next five years and is slated to
start operations in 2021.
Pfizer, AstraZeneca, Merck, and Teva, as well as the Israel Biotech Fund and tech giant
Amazon Web Services (AWS)— to establish an innovation lab in the fields of digital health
and computational biology. The companies were selected from a competitive bid process
conducted by the Israel Innovation
Authority together with the National Digital Israel Initiative at the
National Digital Ministry.
The group will establish the Lab at the Rehovot Science Park
and invest in building a wet computational lab infrastructure in order to
assist early-stage entrepreneurs and startups to meet the challenges of the
healthcare industry, from the ideation stage to attaining proof of concept. The
Lab, scheduled to open in 2021, will be joining existing innovation labs as
part of the Israel Innovation Authority’s Innovation Lab Program.
$10M Operational Budget Over Next 5 Years
The innovation lab will operate on a government budget of
NIS 32 million ($10M USD), as well as additional funding from the partner companies.
The group will operate over the next five years, during which the Innovation
Authority, together with the National Digital Ministry, will finance 85% of a
total NIS 3 million budget for each startup that joins the lab, enabling them
to reach significant milestones in their technological development. The
Innovation Authority and National Digital Ministry will also participate in the
operating costs and in setting up the lab’s infrastructure.
Innovation Lab Focus Areas
The purpose of the Lab is to assist in the establishment and advancement of new startups developing innovative AI-based computational technologies aimed at discovering personalized solutions and treatments. The Lab will also help its startups — with the assistance of the lab partners and access they provide to their unique scientific know-how and leading experts — in developing groundbreaking medications and treatments.
“This last year proved that the healthcare sector is rapidly transitioning to development and use of advanced technologies integrating engineering and biology, which has already led to more accurate results within a shorter time framework. This lab is part of the ‘Bio-convergence Strategy’ promoted by the Innovation Authority over the last year, aimed at establishing a successful, innovative ecosystem in the healthcare sector, which will serve as a proper basis for establishing innovative companies based on groundbreaking academic research performed in these areas in Israel. The expertise and vast experience of the lab partners will enable these companies to establish a significant, trailblazing industry in Israel,” said Aharon Aharon, CEO of the Innovation Authority.
NHS England’s chief executive Sir Simon Stevens has said that all vulnerable people over the age of 50 will be offered a COVID-19 vaccine by “late spring” in a message to healthcare workers.
The prediction comes after the NHS announced on Christmas Eve that more than half a million people had received the Pfizer/BioNTech shot approved in early December, but will depend on additional vaccine supplies coming “on stream”, according to Stevens.
There are around 25 million people classed as vulnerable due to their age or health conditions, and hitting that target will likely rely on the much-anticipated approval of the AstraZeneca/University of Oxford COVID-19 vaccine, said to be coming this week.
The UK has ordered 100 million doses of the AZ vaccine, which unlike the Pfizer/BioNTech shot can be stored and transported at normal temperatures, making it easier to distribute. Around 40 million doses are due to be delivered before the end of March. A third shot from Moderna isn’t expected to be available in the UK until well into next year.
The Pfizer/BioNTech vaccine – which was approved by the EU last week – is being delivered via a network of more than 80 hospital hubs and over 500 GP-led vaccination centres, as well as in care homes in the UK.
That will likely have to be expanded even further if the AZ vaccine is approved and as the immunisation programme gathers pace.
Stevens’ forecast – delivered to staff at a vacciination centre – came alongside a warning that NHS workers are “back in the eye of the storm”, with the number of coronavirus patients in hospitals higher than at the peak of the first wave.
There were around 20,500 hospitalised cases as of this morning, above a peak of just under 19,000 as the first wave hit in April. The UK also recorded a record number of lab-confirmed new cases yesterday at more than 41,000, although that figures reflects a higher level of testing nationally.
At the same time, the new, more transmissible variant of SARS-CoV-2 that was first identified in the UK has been detected in more than 20 other countries around the world, including several EU member states, India, Canada, Japan and Hong Kong.
The leading vaccine developers have said there is no reason their shots will not work against the new variant.
So far there is little evidence of “anti-vaxxer” resistance to the vaccine in the UK. However, in Spain – where more than a quarter of people said they would not take the vaccine in a recent survey – the health ministry has suggested it will set up a registry of people who refuse to be vaccinated and share it with other EU members.
The European Commission has said it expects to deliver 200 million doses of the Pfizer/BioNTech vaccine to EU countries by September 2021.
Novavax vaccine starts US phase 3
Meanwhile, another COVID-19 vaccine has entered the late-stage testing phase in North America. US biotech Novavax has started a phase 3 trial of its recombinant protein-based shot NVX-CoV2373 in the US and Mexico, adding to an ongoing phase 3 trial that started in the UK that is due to read out next year.
The UK government has already signed an agreement with the US biotech to buy 60 million doses of the vaccine in August if trials work out.
The post Vulnerable should all get COVID-19 shot before summer, says NHS chief appeared first on .
Frontline NHS staff have been denied the Pfizer/BioNTech vaccine, leaving doctors alarmed and “scrabbling” to get immunised.
A new survey reveals that almost two-thirds of medics who responded to it have still not had the vaccine, half believe its delivery to the NHS frontline has been “ad hoc” and a third have no idea when they will be offered it. They fear the government’s decision to prioritise over-80s and care home staff above health workers has left them at risk of catching the disease, especially given the emergence of the coronavirus variant, which is 70% more transmissable.
British scientists are trialling a new drug that could prevent someone who has been exposed to coronavirus from going on to develop the disease Covid-19, which experts say could save many lives.
The antibody therapy would confer instant immunity against the disease and could be given as an emergency treatment to hospital inpatients and care home residents to help contain outbreaks.
Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s Approval, HER2-positive Breast Cancer, Phesgo, receives, Roche, Treatment
Published: Dec 22, 2020 | Tags: AMO Pharma, AMO-02, Initiation, REACH-CDM, Treatment of Congenital Myotonic Dystrophy
Published: Dec 22, 2020 | Tags: (dexamethasone ophthalmic insert), Dextenza, Ocular Itching, Ocular Therapeutix, reports, sNDA Submission, Us FDA
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
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
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
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.
The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days.
If the vaccine becomes available the UK will be able to step up its vaccination programme as large swathes of the country face draconian “Tier 4” restrictions due to the emergence of as more infectious variant.
Latest figures show that there were nearly 40,000 cases recorded yesterday, the highest since mass testing began, although it’s thought infection rates were higher during the first wave of the virus in spring when tests were not readily available.
The Medicines and Healthcare products Regulatory Agency (MHRA) began a fast-track rolling review of the vaccine in November and reports point towards a decision between Christmas and New Year.
The UK has ordered 100 million doses of the vaccine, which is based on an adenovirus vector and is easy to handle than rivals from Pfizer/BioNTech and Moderna.
AZ’s vaccine, dubbed AZD1222, is stored at normal refrigerator temperatures while the Pfizer/BioNTech and Moderna shots need to be kept at around -70C and -20C respectively to maintain the integrity of their RNA structure.
According to health secretary Matt Hancock, the full dossier of trial evidence is now with the regulator, which is poised to make a decision in the coming days.
AZ’s vaccine is safe and effective, according to the data publicly available so far, although it seems that giving a half-dose shot first following a second full dose is more effective.
Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.
With two full doses, efficacy is around 62%, according to findings released towards the end of last month based on data from nearly 9,000 patients in the UK and Brazil.
Efficacy rose to around 90% in just over 2,700 patients given the low dose-high dose formulation, which was stumbled on by mistake because of a manufacturing error.
Quite what the MHRA will make of this is not clear, nor is it known whether the regulator has more up-to-date figures than those announced at the end of November.
Professor Sir John Bell, the government’s life sciences tsar and Regius Chair of Medicine at the University of Oxford, told BBC Radio 4’s Today programme yesterday: “We are getting to be about prime time now.
“I would expect some news pretty shortly, I doubt we will make Christmas now but just after Christmas I would expect.
“And I have no concerns whatsoever, the data looks better than ever.”
The post UK prepares for decision on AZ/Oxford vaccine as COVID cases soar appeared first on .
Just a few weeks after its EU approval for heart failure, AstraZeneca’s Forxiga has been backed by NICE for this use by the NHS in England and Wales.
Forxiga (dapagliflozin) – originally developed as a type 2 diabetes drug – is the first SGLT2 inhibitor to be approved for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without diabetes.
It got a green light for this use in the EU in early November and in the US in May, with the new indication helping to drive third-quarter sales up by a third to $525 million.
Approval for Farxiga was based on positive results from the phase 3 DAPA-HF trial, which showed Farxiga achieved a statistically significant and clinically meaningful 26% reduction of death or hospitalisation for heart failure compared with placebo.
Today, NICE issued draft guidance which recommends Forxiga as an option for treating symptomatic HFrEF in adults if used as an add-on to standard drugs, which would make around 260,000 additional people eligible for treatment with the drug.
Novartis’ Entresto (sacubitril/valsartan) is also used to treat HFrEF, an indication which propelled it to sales of almost $2 billion last year.
According to NICE, while there are no head-to-head trials comparing Entresto and Forxiga, AZ’s drug “is likely to be as effective as [Entresto] at reducing the risk of death from heart disease
AZ’s rivals Eli Lilly and Boehringer Ingelheim meanwhile are also attempting to develop their SGLT2 inhibitor Jardiance (empagliflozin) for heart failure. They suffered a setback a year ago when the drug failed to improve exercise ability in two phase 3 studies, but bounced back with the results of the EMPEROR-Reduced study in July.
GlobalData has said that heart failure could add billions to the sales of the two SGLT2 inhibitors, particularly if they also claim approvals in heart failure with preserved ejection fraction (HFpEF), a larger patient population. It says Farxiga will reach peak sales of $9 billion in 2028, with Jardiance forecast to reach $4.6 billion, assuming a launch for HFrEF in 2021.
AZ is also putting Forxiga through its paces in heart failure in combination with other drugs, including its mineralocorticoid receptor modulator AZD9977 and selective endothelin A antagonist zibotentan (also known as AZD4054), with mid-stage trials on the go.
Meanwhile, heart failure is just one area into which AZ is hoping to expand Forxiga before its patents start to expire in the coming years. It’s also looking at chronic kidney disease (CKD), and has picked up a breakthrough designation from the FDA for this indication.
Forxiga was the first medicine to significantly prolong survival in patients with CKD, either with or without diabetes, in the DAPA-CKD trial.
The post NICE backs AZ’s Forxiga for heart failure appeared first on .
What You Should Know:
– The American Medical Association (AMA) announced the addition of three Current Procedural Terminology (CPT) codes for AstraZeneca’s COVID-19 vaccine.
The American Medical Association (AMA) today announced that
the Current Procedural Terminology (CPT®) code set is
being updated by the CPT Editorial Panel to include immunization and
administration codes that are unique to the COVID-19 vaccine under development
by AstraZeneca and University of Oxford.
The new CPT codes will be effective for use on the condition
that the AstraZeneca vaccine receives approval or emergency use authorizations
from the Food and Drug Administration (FDA). The AMA is publishing the new CPT
codes now to ensure electronic systems across the U.S. health care
system are updated and prepared for the prospect of FDA approval or
authorization for the AstraZeneca vaccine.
Growing List
of CPT Codes to Support COVID-19 Vaccines
The AstraZeneca vaccine joins two other COVID-19 vaccines that were previously issued unique CPT codes to report vaccine-specific immunizations once FDA approval or authorization has been granted. On Nov. 10, the AMA announced that COVID-19 vaccines developed by Pfizer and Moderna had been issued unique CPT codes to clinically distinguish each vaccine for better tracking, reporting, and analysis that supports data-driven planning and allocation
AstraZeneca COVID-19 Vaccine CPT Codes Overview
The new
Category I CPT code and long descriptor for the AstraZeneca vaccine are:
91302: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative-free, 5×1010 viral particles/0.5mL dosage, for intramuscular use
In addition to the new vaccine-specific product CPT code, the AstraZeneca vaccine has been issued vaccine administration CPT codes that are distinct to its two-dose immunization schedule. These CPT codes report the actual work of administering the vaccine, in addition to all necessary counseling provided to patients or caregivers and updating the electronic record.
For quick reference, the new vaccine administration CPT codes and long descriptors for the AstraZeneca vaccine are:
0021A: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative-free, 5×1010 viral particles/0.5mL dosage; first dose
0022A: second dose
In addition to the long descriptors, short and medium descriptors for all the new vaccine-specific CPT codes can be accessed on the AMA website, along with several other recent modifications to the CPT code set that have helped streamline the public health response to the SAR-CoV-2 virus and the COVID-19 disease.
“A mass vaccination effort with the first available COVID-19 vaccines presents enormous logistical challenges,” said AMA President Susan R. Bailey, M.D. “The ability to correlate each COVID-19 vaccine with its own unique CPT code provides analytical and tracking advantages that ensures optimal vaccine distribution and administration, especially for patients who will need to complete the two-dose immunization schedule.”
AstraZeneca and Amgen looked on course to cruise to approval of their severe asthma drug tezepelumab with a pair of positive clinical trials, but the failure of a third threatens to derail the programme.
The new study – called SOURCE – was supposed to back up the encouraging readouts from the phase 3 NAVIGATOR trial and phase 2b PATHWAY, which found that the antibody benefited asthma patients whose symptoms were so bad they needed oral corticosteroid (OCS) therapy.
SOURCE has changed the script however by missing its primary objective, proving unable to significantly reduce the daily dose of OCS needed by patients in the 150-subject trial, although AZ and Amgen still think the drug is approvable based on the “totality of evidence”.
AZ and Amgen have only released the top-line data, so it could be a while before an explanation for the failure emerges, although AZ’s head of biopharmaceuticals R&D Mene Pangalos suggested it may have resulted from flaws in the trial design.
Just a month ago, AZ and Amgen trumpeted the result of the NAVIGATOR trial of tezepelumab, a first-in-class inhibitor of the cytokine thymic stromal lymphopoietin (TSLP) that analysts have said could have blockbuster potential if approved, perhaps reaching as much as $2.5 billion in annual sales.
NAVIGATOR found that the antibody reduced the asthma exacerbations compared to placebo when added to standard care, and crucially also seemed to have a positive impact on patients with low levels of white blood cells called eosinophils.
Biologics like GlaxoSmithKline’s Nucala (mepolizumab) and AZ’s Fasenra (benralizumab) – both IL-5 inhibitors – and Sanofi/Regeneron’s IL-4 and IL-13 blocker Dupixent (dupilumab) are already approved to treat severe eosinophilic asthma but treatment options are limited for patients with non-eosinophilic forms.
Tezepelumab claimed a breakthrough designation in non-eosinophilic asthma from the FDA in 2018, on the promise that it could provide an option for these patients, who account for around a third of all severe asthma cases.
The drug acts further upstream in the inflammatory cascade than its rivals and so could be effective for a broader range of patients, according to its developers.
AZ and Amgen say they still plan to press ahead with plans for regulatory filings for tezepelumab next year, and will prevent detailed results from NAVIGATOR and SOURCE at a future medical conference.
The two partners started working together on tezepelumab in 2012, and was one of five drugs covered by that alliance. It has previously failed a mid-stage study in atopic dermatitis, but is still in development for that indication as well as chronic obstructive pulmonary disease (COPD).
The post AZ, Amgen’s asthma hope tezepelumab flunks phase 3 trial appeared first on .
Click here to read full press release/ article | Ref: AstraZeneca | Image: Physicians Practice
The post AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma first appeared on PharmaShots.
Click here to read full press release/ article | Ref: BusinessWire | Image: Marketwatch
The post AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer first appeared on PharmaShots.
AstraZeneca’s Tagrisso (osimertinib) has been approved by the FDA in a new lung cancer indication that extends its use to a group of patients with early-stage disease.
The new use covers adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after a potentially curative operation.
Patients must be tested to for the presence of the mutation to check they are eligible to receive the oral drug.
Up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery.
But disease recurrence is still common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.
Based on the findings of the phase 3 ADAURA study this could change, as Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in a primary analysis of patients with Stage II and Stage IIIa NSCLC with EGFR mutations.
This was also seen in the overall trial population of patients with Stage 1B-IIIA disease, the secondary endpoint of the trial.
Findings showed that Tagrisso cut the risk of disease recurrence by 83% compared with placebo in the trial that was stopped early because of the high efficacy shown in the treatment arm.
The ADAURA results were showcased as the last set presentation at this year’s virtual American Society of Clinical Oncology conference, rather like the headline performer at a rock festival.
Results dazzled the oncologists who described the findings as a “home run” and the new indication will also have beneficial side-effect on AZ’s finances, adding substantially to the blockbuster revenues already generated by Tagrisso.
The results also suggest further uses for the drug in early disease and more revenues to come from one of the company’s biggest success stories from the last decade.
Tagrisso was first approved in 2015 to counter a single amino acid mutation known as T790M that nearly always occurs after about 10 months of treatment with tyrosine kinase inhibitor drugs, making tumours resistant.
But after approval in later stage disease, AZ found that the drug outperforms rival tyrosine kinase inhibitors as a first-line treatment in the FLAURA trial, leading to a second FDA indication two years ago.
Tagrisso is already a blockbuster bringing in revenues of more than $3.1 billion in the first nine months of this year, and the new indication will add further momentum to AZ’s biggest selling drug.
The post AZ’s Tagrisso gets new early lung cancer use in US appeared first on .
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.
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
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
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
Published: Dec 16, 2020 | Tags: Advanced, Amgen, KRAS G12C, Metastatic, Mutation, NDA, NSCLC, reports, Sotorasib, Submission, Us FDA
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
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
Published: Dec 15, 2020 | Tags: Belt, Bone Health Technologies, Breakthrough, Designation, Device, OsteoBoost, receives, USFDA, Vibration
Published: Dec 15, 2020 | Tags: (budesonide oral suspension), Eosinophilic Esophagitis (EoE), NDA, reports, TAK-721, Takeda, US FDA’s Acceptance
Published: Dec 15, 2020 | Tags: (tirbanibulin), Actinic Keratosis, Athenex’s, Face, Klisyri, receives, Scalp, US FDA’s Approval
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
Published: Dec 14, 2020 | Tags: Agreement, Commercialization, Develop, Genentech, Relay Therapeutics, RLY-1971, Signs, Worldwide License
Published: Dec 14, 2020 | Tags: approval, Genentech, Multiple Sclerosis, ocrelizumab, Ocrevus, Primary, Progressive, receives, Relapsing, Us FDA
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.
MacroGenics’ HER2-targeted breast cancer drug Margenza has been approved by the FDA, challenging several recently approved drugs with a narrow efficacy edge over Roche’s Herceptin in data gathered so far in advanced disease.
Margenza (margetuximab) won FDA approval in combination with chemotherapy to treat metastatic HER2-positive breast cancer after at least two previous rounds of therapy.
One of the talking points at the American Society of Clinical Oncology (ASCO) in 2019, Margenza is a tweaked version of Roche’s Herceptin (trastuzumab), which dominated the HER2-mutated breast cancer market for years until the recent launch of cut-price biosimilar competitors.
MacroGenics has altered the “Fc” part of the antibody – the tail of the ‘Y’-shaped molecule – so that it interacts more efficiently with the immune system when engaged with a cancer cell.
This has produced a small but significant benefit in progression-free survival, with the phase 3 SOPHIA study showing a 24% reduction in the risk of disease progression or death with Margenza plus chemotherapy, compared with trastuzumab plus chemo.
The median progression-free survival (PFS) of patients treated with Margenza and chemotherapy was 5.8 months compared to 4.9 months in patients treated with trastuzumab and chemotherapy.
The difference was more marked in patients carrying a genetic variation called CD16A 158F, where PFS was prolonged by 1.8 months in the margetuximab arm compared to the trastuzumab arm (6.9 months versus 5.1 months).
Response rate was also improved with the Margenza regimen at 22%, compared with 16% in those treated with the Herceptin regimen.
A final overall survival analysis is expected in the second half of 2021, after a planned launch in March next year.
No price has been officially decided but the company said it plans to price it at the low end of the price range seen in other HER2 metastatic breast cancer therapies.
Those competing therapies include Seagen’s Tukysa (tucatinib), which was approved in May for advanced HER2-positive disease in combination with trastuzumab and capecitabine after treatment with at least one HER2-targeted drug.
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) was approved a year ago for HER2-positive breast cancer after two or more previous HER2 regimens and Puma’s Nerlynx (neratinib) is another FDA-backed option in this indication.
The post MacroGenics’ HER2 breast cancer drug Margenza approved in US appeared first on .
The lawsuit follows action by at least a half-dozen drug companies to rein in what they see as waste and abuse in the program, overseen by the Department of Health and Human Services. Meanwhile, the Hospital plaintiffs have a potentially powerful ally in the person picked to head the department under the incoming Biden administration.
Vaccinating the population against Covid-19 will cost up to £12bn, Whitehall’s spending watchdog has disclosed, amid details of tensions between health bodies over the rollout.
The National Audit Office said the government would spend up to £11.7bn on purchasing and manufacturing Covid-19 jabs for the UK before deploying them in England.
Related: Can the UK deliver on the Covid vaccine rollout? | Stephen Buranyi
Related: Kate Bingham: well-connected but under-fire UK vaccines chief
Click here to read full press release/ article | Ref: AstraZeneca | Image: EORTC
The post EMA’s CHMP Recommends Four-Week Dosing Option for AstraZeneca’s Imfinzi to Treat Unresectable NSCLC first appeared on PharmaShots.
Gannex Pharma has received Fast Track designation approval from FDA for its drug candidate ASC42 for non-alcoholic steatohepatitis (NASH). The FTA designation will help the pharma company to advance its research and development in the NASH landscape and help its commercialization in the market.
At present, there are no approved therapies for NASH. The present NASH treatment market is dominated and supported by off-label therapies. DelveInsight estimated that the coming future for NASH market is expected to experience entry of more such off-label therapies unless an approved cure arrives.
The US FDA decision to grant FTA to ASC42 depicts the potential of the therapy in addressing the unmet medical needs for NASH patients. ASC42 is an oral fatty acid synthase (FASN) inhibitor that has managed to significantly reduce the liver fat in Phase II clinical trial (FASCINATE-1).
Gannex has two additional drug candidates as well that are at the clinical stage in its NASH pipeline, ASC40 and ASC41.
Incyte announced the results from the Phase III RUXCOVID study investigating the safety and efficacy of ruxolitinib (Jakafi®) for patients 12 years and older with COVID-19 associated cytokine storms.
Ruxolitinib is an orally administered inhibitor of the JAK 1 and JAK 2 tyrosine kinases. The Phase III RUXCOVID study tested ruxolitinib on top of standard of care or SoC therapy compared to SoC treatment alone in patients with COVID-19.
The initial data from the trial demonstrated no statistically significant reduction in the number of hospitalized COVID-19 patients receiving ruxolitinib plus SoC therapy who experienced severe complications including death, mechanical ventilation or ICU care by Day 29, compared to SoC treatment alone.
The drug, Ruxolitinib, is commercialized by Incyte in the US; and is licensed to Novartis outside the U.S. Sold under the name Jakafi, it is FDA-approved for the treatment of polycythemia vera (PV) in adults.
In a historic first, the US FDA issued an Emergency Use Authorization (EUA) to the COVID-19 mRNA, BNT162b2, vaccine candidate for COVID-19 of Pfizer-BioNTech. The duo plans to accumulate additional data and file for Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.
COVID-19 still continues to ravage human society turning the economy upside down. And, the EUA is a pivotal move in the quest to turn back things to normal. The vaccine is the first-ever mRNA vaccine to get to the EUA and is developed in record-time low.
The decision of the regulatory agency was based on the results from a pivotal Phase 3 clinical study announced last month and published this week in The New England Journal of Medicine. The data depicted the efficacy rate of the vaccine of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective).
The U.K. was the first to give its nod to the vaccine followed by Bahrain, Canada, Saudi Arabia and now, the U.S.
AstraZeneca is ready to dish-out USD 39 Billion to acquire rare disease stalwart Alexion. It seems a global oncology performer, AZ is now taking interest in the rare disease landscape.
Not long ago, another pharma titan, Gilead acquired Immunomedics by shelling-out USD 21 Billion in one of the most expensive and bold moves. However, AstraZeneca has outwon Gilead with even a large one with a prime focus on rare disease portfolio.
After the acquisition, the companies plan to strengthen a spectrum of domains, technologies, and therapeutic areas to bring innovative therapies to people. The duo will also have an expanded coverage across primary, speciality and highly specialised care and increased geographical reach.
The combined entity will put forward two rapidly converging, patient-centric models of care delivery with combined strengths in immunology, biologics, genomics and oligonucleotides to drive future medicine innovation
Elvire Gouze, a scientist, entrepreneur, and an expert in skeletal disorders, has come up with another startup company, InnoSkel, with an aim to move forward in developing innovative gene therapy platform for a wide variety of life-threatening skeletal diseases.
The company is officially launched with €20 million ($24 million) in first-round financing led by Jeito Capital alongside Vida Ventures and the Turenne Group to advance the platform. InnoSkel is Jeito’s third investment in the past four months, after SparingVision and Neogene.
Earlier the scientist has sold her first biotech, Therachon, to Pfizer for a hefty USD 810 million. In similar lines with Therachon, InnoSkel is also committed to focusing on diseases that cause dwarfism, however, this time the approach towards treatment is different.
The proceeds from the financing are expected to be consumed in advancing InnoSkel’s asset pipeline from its dedicated gene therapy platform, including a group of rare and life-threatening skeletal disorders collectively known as type 2 collagenopathies, the most severe being, a neonatal presenting skeletal disorder called Spondyloepiphyseal Dysplasia congenita (SEDc).
The post FTA for Gannex’s ASC4; Disappointment for Incyte’s Ruxolitinib; Historic win for Pfizer, BioNTech’s COVID Vaccine; Alexion buyout; the debut of InnoSkel appeared first on DelveInsight Business Research.
This is the government’s problem as it reopens talks on a proposed nuclear power station at Sizewell C in Suffolk: it is contemplating ordering a replica of Hinkley Point C before the Somerset original has produced a single megawatt of electricity.
That is not a small point. Developer EDF’s pre-Hinkley version of its European pressurised reactor at Flamanville in Normandy is about a decade behind schedule. What’s more, EDF wants UK taxpayers or bill-payers to bear more of the construction risks at Sizewell, a less-than-compelling offer when you remember that Flamanville is also €9bn (£8.2bn) over budget.
AstraZeneca shares fell sharply after it agreed to a $39bn (£29bn) takeover of the US rare diseases specialist Alexion, the biggest deal in its history if it goes ahead.
Investors sold off shares in the Anglo-Swedish drugmaker over fears it was paying too much for Alexion in the stock-and-shares deal. The offer price of $175 a share represents a 45% premium on Alexion’s closing price before the deal was announced. To finance the deal, AstraZeneca has secured a $17.5bn bridging loan.
Click here to read full press release/ article | Ref: Business wire | Image: GlassDoor
The post Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for Approval to Treat HER2 Positive Metastatic Breast Cancer first appeared on PharmaShots.
Daiichi Sankyo and AstraZeneca could be just weeks away from an EU approval for their antibody-drug conjugate (ADC) for breast cancer – Enhertu – which is tipped to become a multibillion-dollar blockbuster.
At its meeting last week, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Enhertu (trastuzumab deruxtecan) for patients with unresectable or metastatic HER2-positive breast cancer, who have been previously treated with other anti-HER2 drugs.
Enhertu has already been approved for third-line use in HER2-positive breast cancer in the US at the end of 2019 and in Japan earlier this year, based on the results of the phase 2 DESTINY-Breast01 trial in 184 patients, which revealed that the drug shrank tumours in 61% of recipients.
Revenues from the drug in the first nine months of 2020 came in at $136 million – including $60 million in the third quarter.
Sales were recorded by Daiichi Sankyo, with AZ pocketing $63 million in profit sharing, and according to AZ the drug is now the most prescribed medicine in the third-line and fourth-line settings of HER2-positive metastatic breast cancer.
Enhertu consists of the antibody used in Roche’s blockbuster HER2 antibody Herceptin (trastuzumab), linked to a topoisomerase inhibitor that is toxic to cancer cells. Around one in five patients with breast cancer are considered HER2 positive, which is associated with aggressive disease, a high recurrence rate, and an increased risk of dying.
It works by latching on to HER2-positive cancer cells and delivering a payload to kill them, while ignoring healthy cells, in patients who have failed to respond to Roche’s HER2-targeting cancer drugs Herceptin, Perjeta (pertuzumab), and ADC Kadcyla (trastuzumab emtansine).
Kadcyla was once tipped to become the go-to treatment HER2-posiitve breast cancer when first line drugs like Herceptin/Perjeta had failed, but failed to meet the mark in pivotal trials, truncating its sales growth although it still managed to break into the $1 billion-plus bracket.
Daiichi Sankyo is confident Enhertu can top Roche’s ADC, and also expand the use of HER2 drugs into new cancers like HER2-positive gastric cancer – an indication that is under review by the FDA with a verdict due early next year – and HER2-positive non-small cell lung cancer (NSCLC).
The intention is to gradually position the drug for earlier-line use in breast, gastric and lung cancer, and eventually to try to expand its use into certain low HER2-expressing tumours.
If all the pieces fall into place it reckons peak sales could reach $4.5 billion, and there are plenty of analysts predicting that the drug could quickly breach the $2 billion-a-year threshold.
AZ’s confidence in the potential of Enhertu is evidence from the terms of its late 2019 licensing deal with Daiichi Sankyo, which included a hefty $1.35 billion upfronting a deal that could be worth up to $6.9 billion if all the ADC’s development and sales objectives are achieved.
The post Daiichi Sankyo, AZ close on EU approval of Enhertu for breast cancer appeared first on .
Click here to read full press release/ article | Ref: Businesswire | Image: San Diego Business Attorney
The post AstraZeneca to Acquire Alexion for B first appeared on PharmaShots.
Alexion has routinely featured among lists of top biopharma takeover prospects in the last couple of years, and that was a good call – AstraZeneca has just swooped in with $39 billion cash-and-stock takeover offer.
The deal – the largest in the pharma sector since the start of the pandemic – bolsters AZ’s immunology franchise with $4 billion blockbuster Soliris (eculizumab) and longer acting follow-up Ultomiris (ravulizumab), plus a pipeline of 11 drugs for rare and autoimmune diseases.
The transaction values Alexion at $175 per share, a sizeable 45% premium on its closing price on Friday, the day before the deal was announced.
Alexion shareholders will receive $60 in cash, plus 2.12 of AZ’s US-listed shares for each share they hold, ending up owning around 15% of the combined company.
Analysts at SVB Leerink said that while the offer is fair at that price, Alexion is a “scarce and high-quality asset,” which could prompt an offer from another company. In the past, Novartis, Roche, Pfizer and Amgen have all been mentioned as potential suitors.
It marks something a departure from AZ’s relentless focus on deal-making in oncology, its top product category, and also comes as Alexion has been locked in a battle with activist shareholders pushing for a sale.
Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.
The threat of biosimilar competition to its cash cow has weakened Alexion’s share price, providing an opportunity for AZ, which has been rumoured to be angling for a large acquisition for several months.
While the first biosimilars to Soliris have already reached the market in some countries like Russia, Alexion cut a settlement deal with Amgen in the summer that prevents the latter’s biosimilar version of Soliris from entering the US market until 2025, avoiding a near-term cash cliff.
In the meantime, Ultomiris has been gathering momentum, fuelled by intravenous dosing every eight weeks, rather than every two weeks with Soliris. It racked up $340 million in sales last year, and added another $763 million in the first nine months of this year, backing up its blockbuster credentials.
Soliris was the first drug to become available for each of its approved indications: paroxysmal nocturnal hemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD).
Ultomiris is already approved for PNH and aHUS and in late-stage development for NMOSD, which could lend further momentum.
Meanwhile, AZ will also picks up three other drugs – Strensiq (asfotase alfa) for hypophosphatasia, Kanuma (sebelipase alfa) for lysosomal acid lipase deficiency (LAL-D) and anticoagulant reversal agent Andexxa (andexanet alfa) – that collectively brought in almost $675 million in the first nine months of 2020.
AZ is taking on debt to fund the deal but should pay that off quickly given Alexion should book double-digit growth in the coming years, which could be enhanced by AZ’s broader footprint in Europe and Asia.
Alexion has been working hard to flesh out is pipeline as well, snapping up Achillion Pharma, Syntimmune, Wilson Therapeutics and Portola and forging an alliance with gene-silencing specialist Dicerna focusing on complement diseases.
Along with new indications for its existing drugs, the Swiss biopharma has four more drugs in phase 3 development that could benefit from the increased financial and development muscle that AZ will bring to the table.
That includes ALXN1840 for genetic disorder Wilson disease, with results due in the first half of next year, as well as CAEL-101 for light chain amyloidosis, AG10 for ATTR cardiomyopathy and ALXN2040 or PNH patients with extravascular haemolysis (EVH).
“Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases,” said AZ’s chief executive Pascal Soriot.
“This acquisition allows us to enhance our presence in immunology,” he added. “We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.”
The combined company will be able to carve around $500 million a year off its cost base, and will deliver double-digit growth average annual revenue growth through 2025, providing cash flow to reinvest in R&D, said the two companies in a statement.
The post Alexion finally has a buyer – and it’s AstraZeneca with $39bn on the table appeared first on .
Alexion has routinely featured among lists of top biopharma takeover prospects in the last couple of years, and that was a good call – AstraZeneca has just swooped in with $39 billion cash-and-stock takeover offer.
The deal – the largest in the pharma sector since the start of the pandemic – bolsters AZ’s immunology franchise with $4 billion blockbuster Soliris (eculizumab) and longer acting follow-up Ultomiris (ravulizumab), plus a pipeline of 11 drugs for rare and autoimmune diseases.
The transaction values Alexion at $175 per share, a sizeable 45% premium on its closing price on Friday, the day before the deal was announced.
Alexion shareholders will receive $60 in cash, plus 2.12 of AZ’s US-listed shares for each share they hold, ending up owning around 15% of the combined company.
Analysts at SVB Leerink said that while the offer is fair at that price, Alexion is a “scarce and high-quality asset,” which could prompt an offer from another company. In the past, Novartis, Roche, Pfizer and Amgen have all been mentioned as potential suitors.
It marks something a departure from AZ’s relentless focus on deal-making in oncology, its top product category, and also comes as Alexion has been locked in a battle with activist shareholders pushing for a sale.
Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.
The threat of biosimilar competition to its cash cow has weakened Alexion’s share price, providing an opportunity for AZ, which has been rumoured to be angling for a large acquisition for several months.
While the first biosimilars to Soliris have already reached the market in some countries like Russia, Alexion cut a settlement deal with Amgen in the summer that prevents the latter’s biosimilar version of Soliris from entering the US market until 2025, avoiding a near-term cash cliff.
In the meantime, Ultomiris has been gathering momentum, fuelled by intravenous dosing every eight weeks, rather than every two weeks with Soliris. It racked up $340 million in sales last year, and added another $763 million in the first nine months of this year, backing up its blockbuster credentials.
Soliris was the first drug to become available for each of its approved indications: paroxysmal nocturnal hemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD).
Ultomiris is already approved for PNH and aHUS and in late-stage development for NMOSD, which could lend further momentum.
Meanwhile, AZ will also picks up three other drugs – Strensiq (asfotase alfa) for hypophosphatasia, Kanuma (sebelipase alfa) for lysosomal acid lipase deficiency (LAL-D) and anticoagulant reversal agent Andexxa (andexanet alfa) – that collectively brought in almost $675 million in the first nine months of 2020.
AZ is taking on debt to fund the deal but should pay that off quickly given Alexion should book double-digit growth in the coming years, which could be enhanced by AZ’s broader footprint in Europe and Asia.
Alexion has been working hard to flesh out is pipeline as well, snapping up Achillion Pharma, Syntimmune, Wilson Therapeutics and Portola and forging an alliance with gene-silencing specialist Dicerna focusing on complement diseases.
Along with new indications for its existing drugs, the Swiss biopharma has four more drugs in phase 3 development that could benefit from the increased financial and development muscle that AZ will bring to the table.
That includes ALXN1840 for genetic disorder Wilson disease, with results due in the first half of next year, as well as CAEL-101 for light chain amyloidosis, AG10 for ATTR cardiomyopathy and ALXN2040 or PNH patients with extravascular haemolysis (EVH).
“Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases,” said AZ’s chief executive Pascal Soriot.
“This acquisition allows us to enhance our presence in immunology,” he added. “We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.”
The combined company will be able to carve around $500 million a year off its cost base, and will deliver double-digit growth average annual revenue growth through 2025, providing cash flow to reinvest in R&D, said the two companies in a statement.
The post Alexion finally has a buyer – and it’s AstraZeneca with $39bn on the table appeared first on .
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
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
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
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
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
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
Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, AbbVie, CLL, ILLUMINATE Study, Imbruvica, Integrated Analysis, Long-Term, P-lll, reports, RESONATE-2
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
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
Published: Dec 5, 2020 | Tags: Based, CLL14, combination, MURANO, P-III, People, R/R CLL, reports, results, Roche, Studies, Venclexta, Venclyxto
Published: Dec 5, 2020 | Tags: Adult, iNHL, Kite, P-II, patients, Refractory, Relapsed, reports, results, study, Yescarta, ZUMA-5
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.
For a man presenting landmark results from trials of a vaccine that it is hoped will save the world from a devastating pandemic, Sir Menelas Pangalos did not look cheerful on Wednesday.
Pangalos, executive vice-president of biopharmaceuticals R&D at AstraZeneca, and his colleagues are undoubtedly exhausted, having been working round the clock on the coronavirus vaccine with Oxford University since April. But they are now dealing with a sizeable new headache – the doubts of the US regulator.
NHS England is to grant immediate access to AstraZeneca’s cancer drug Calquence (acalabrutinib) for certain patients with chronic lymphocytic leukaemia (CLL) after NICE backed it in first draft recommendations.
NICE recommended regular NHS funding for Calquence in CLL who are considered high-risk due to 17p deletion or TP53 mutations.
It is also recommended for adults with CLL who have had at least one previous treatment and only if AbbVie and Janssen’s class rival Imbruvica (ibrutinib) is their only suitable treatment option.
NHS England is granting access via an interim funding arrangement with AstraZeneca, which will end 30 days after publication of positive final guidance, after which treatment will be funded by routine commissioning budgets.
However the guidance has rejected Calquence for a third group of patients with untreated, non-high risk CLL who are unsuitable for treatment with chemotherapy.
AZ said it will provide further data analyses for continued discussions with NICE about this group of patients.
Calquence was approved in CLL by the EMA last month as monotherapy or in combination with Roche’s Gazyvaro (obinutuzumab).
In CLL, too many blood stem cells in the bone marrow become abnormal white blood cells, and these have difficulty in fighting infections.
As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets. This could result in anaemia, infection, and bleeding.
B-cell receptor signalling through Bruton’s tyrosine kinase (BTK) is one of the essential growth pathways for CLL.
In B-cells, BTK signalling results in the activation of pathways necessary for growth: proliferation, trafficking, chemotaxis, and adhesion.
Calquence binds selectively to BTK, inhibiting its activity.
This is the second recommendation of a therapy for CLL in the space of a month – in November it recommended AbbVie/Roche’s chemotherapy-free option of Venclyxto (venetoclax) and Gazyva.
NICE’s decision allows for a 12-month fixed duration treatment option based on data from the phase 3 CLL14 trial.
The post CLL patients in England to get AZ’s Calquence after okay from NICE appeared first on .
Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, but GlaxoSmithKline’s Nucala is now breathing down its neck.
The FDA has started its review of Nucala (mepolizumab) for the inflammatory condition, which results in the growth of nasal polyps in the nose that can obstruct airflow and cause mucus discharge, sometimes requiring surgical intervention.
In severe cases, polyps recur, so patients have to undergo multiple operations that according to GSK progressively become less effective and more risky.
The anti-IL-5 antibody is already approved by the FDA for severe asthma and two other conditions – hypereosinophilic syndrome (HES) and eosinophilic granulomatosis with polyangiitis – and is one of GSK’s top growth products with sales rising 28% to more than $930 million in the first nine months of this year.
If approved, it will be the first biologic challenger to Dupixent (dupilumab) – which has a different mechanism of action targeting IL-4 and IL-13 – and would also keep Nucala ahead of IL-5 class rivals like Teva’s Cinqair (reslizumab) and AstraZeneca’s Fasenra (benralizumab) that are challenging it in asthma.
The FDA’s review centres on the SYNAPSE trial, which involved 400 patients with a history of previous surgery who were in need of another procedure due to growing polyps and severe symptoms.
The drug improved both the size of nasal polyps at week 52 and in nasal obstruction during weeks 49-52, compared to placebo when added to standard of care, and extended the time to surgery by 57%.
Standard care for CRSwNP consists of corticosteroids in the nose, after surgery and systemic corticosteroids, but these often lack efficacy.
AZ reported positive results with Fasenra in CRSwNP in September, so may not be far behind with its own regulatory filings, and has also started to catch up with first-to-market Nucala in sales terms, growing 34% to $666 million in the first three quarters of 2020.
Regeneron meanwhile said last month that CRSwNP has been helping to drive increased sales of Dupixent, with a “strong uptick” in prescribing for this indication this year as well as a good performance in other uses like atopic dermatitis that drive it to more than $1.1 billion in global sales in the third quarter alone.
The post Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps appeared first on .
Nine out of 10 people in 70 low-income countries are unlikely to be vaccinated against Covid-19 next year because the majority of the most promising vaccines coming on-stream have been bought up by the west, campaigners have said.
As the first people get vaccinated in the UK, the People’s Vaccine Alliance is warning that the deals done by rich countries’ governments will leave the poor at the mercy of the rampaging virus. Rich countries with 14% of the world’s population have secured 53% of the most promising vaccines.
In the early afternoon of 3 January this year, a small metal box was delivered to the Shanghai Public Health Clinical Centre addressed to virus expert Prof Zhang Yongzhen. Inside, packed in dry ice, were swabs from a patient who was suffering from a novel, occasionally fatal respiratory illness that was sweeping the city of Wuhan. Exactly what was causing terrifying rises in case numbers, medical authorities wanted to know? And how was the disease being spread?
Related: ‘I worked so hard in the lab. I cried when the news came’
What Zhang did was critical … Without the information he provided no one could have started working on vaccines
Related: Team behind Oxford Covid jab start final stage of malaria vaccine trials
Related: NHS staff no longer at front of queue for Covid vaccine after rethink
Never before has the world awaited a new medicine with such bated breath. A vaccine for Covid-19 has the potential to unlock society and save millions of people from death and serious disease, and the hero of the hour is an industry that is often regarded with disdain.
“Traditionally and historically, public trust in pharma has been comparable to the trust they put in their broadband provider,” said Alex Davies, a healthcare PR expert at Hanover Communications, which counts many drug companies as clients.
The 4th Antigen Specific Immune Tolerance Digital Summit (ASIT) brings together industry representatives from the fields of autoimmunity, allergy, immuno-oncology and transplantation to tackle the complexities behind autoimmune disorders head on. With momentum building for antigen specific immunotherapies, ASIT 2021 will be the only antigen-specific summit offering thought-leading content to drive the field towards a more precise and ethical antigen-specific approach to drug development.
This is the industry’s definitive antigen specific drug development forum.
Across 3 packed days, thought leaders from Novartis, ImCyse, Harvard Medical School, Toleranzia, Toralgen will reveal insight, data, and lessons learned from the last 12 months to enable you to hurdle the roadblocks preventing the development of clinically safe and effective antigen-specific immunotherapies for autoimmune and immune mediated disorders.
Access the official agenda for more information.
The post 4th Antigen Specific Immune Tolerance Summit appeared first on .
Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC).
J&J’s Janssen unit is seeking approval of the drug in a specific patient group – those with exon 20 insertion mutations whose disease has progressed despite first-line chemotherapy.
Janssen has ambitions to expand the use of the drug into the larger EGFR inhibitor market, which at the moment, is led by AstraZeneca’s fast-growing EGFR tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib).
Amivantamab (formerly JNJ-6372) is a bispecific or double-headed antibody, combining an EGFR-binding domain at one end with one targeting mesenchymal epithelial transition (MET) factor, which is a common resistance mechanism that can reduce the activity of EGFR drugs.
That means it targets both the primary mutation in this form of NSCLC and the resistance mechanism at the same time, according to J&J, which has previously said it plans to expand use of the drug to “all EGFR-containing tumours”, challenging Tagrisso and other TKIs like AZ’s older Iressa (gefitinib) and Roche’s Tarceva (erlotinib).
Amivantamab is also the first drug to be filed specifically for patients with exon 20 mutations, who don’t tend to respond well to current therapies including EGFR inhibitors, and as a result picked up a breakthrough designation from the FDA for this use.
EGFR mutations are some of the most common mutations in NSCLC, and that has driven sales of Tagrisso – the standard of care for previously-untreated EGFR-positive NSCLC – to more than $3 billion last year.
The Exon 20-mutated population is fairly large in its own right, as these mutations are the third most prevalent primary EGFR mutation. That said, they often go undetected, so J&J will have to develop ways to identify suitable patients if amivantamab is to make headway in the market.
In the summer, the drugmaker signed partnered with Guardant Health to seek regulatory approval of a companion diagnostic for amivantamab that will be used to identify suitable patients.
Along with the marketing approval submission, J&J has also set up an expanded access programme, which would allow patients at need to use the drug while the FDA review is underway.
Patients with exon 20 insertion mutations have a median survival of less than 17 months, around half that of patients with other EGFR mutations.
Amivantamab has been filed for approval based on the phase 1 CHRYSALIS study which showed that the drug shrank tumours in 36% of all patients in the study, and 41% of those previously treated with chemo. The median durations of response were 10 months and seven months, respectively.
CHRYSALIS also included an arm that combined amivantamab with lazertinib, an experimental EGFR TKI that J&J licensed from South Korea’s Yuhan in 2018, which showed a 100% ORR with the combination in previously-untreated EGFR-mutant NSCLC.
That result prompted J&J to start a phase 3 trial comparing the duo to Tagrisso directly in treatment-naïve patients. Called MARIPOSA, it will compare Tagrisso to lazertinib alone as well as the combination.
Meanwhile, J&J is also exploring the use of amivantamab in patients who have failed TKI therapy and only have chemo as an option.
Both lazertinib and amivantamab – which was developed using technology from Danish biotech Genmab – have blockbuster sales potential, according to the company.
The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on .
Celltrion Presented Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020
Published: Nov 03, 2020
Product: CT-P17 (biosimilar, adalimumab)
Formycon Reported BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)
Published: Nov 06, 2020
Product: FYB201 (biosimilar, ranibizumab)
Formycon and Bioeq Reported First Patient Dosing in P-III Study of FYB202 (biosimilar, ustekinumab)
Published: Nov 09, 2020
Product: FYB202 (biosimilar, ustekinumab)
Alvotech and Cipla Collaborated to Ensure Access to Biosimilars in South Africa
Published: Nov 09, 2020
Product: Biosimilar
Genentech Filed Complaint Against Centus Over Proposed Bevacizumab Biosimilar
Published: Nov 13, 2020
Product: Proposed Bevacizumab Biosimilar
Published: Nov 11, 2020
Product: Tuznue (biosimilar, trastuzumab)
Samsung Bioepis Initiated P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)
Published: Nov 11, 2020
Product: SB16 proposed biosimilar to Prolia
Henlius Reported First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)
Published: Nov 11, 2020
Product: HLX14 (denosumab, biosimilar)
Published: Nov 11, 2020
Product: Xlucane (biosimilar, ranibizumab)
Henlius Reported the NMPA’s Acceptance of HLX15 (biosimilar, daratumumab) to Treat Multiple Myeloma
Published: Nov 16, 2020
Product: HLX15 (biosimilar, daratumumab)
Published: Nov 16, 2020
Product: SB11 proposed biosimilar to Lucentis
Published: Nov 18, 2020
Product: SB11 proposed biosimilar to Lucentis
The US FDA Draft New Guidelines for Biosimilarity and Interchangeability
Published: Nov 19, 2020
Product: Biosimilar
Shots:
Product: Nov 20, 2020
Product: AVT02, a proposed biosimilar to Humira
Henlius Presented Results of HLX04 (biosimilar, bevacizumab) in P-III Study at ESMO Asia 2020
Published: Nov 20, 2020
Product: HLX04 (biosimilar, bevacizumab)
Samsung Biologics and AstraZeneca Dissolved Rituximab Alliance
Published: Nov 20, 2020
Product: SAIT101 (biosimilar, rituximab)
Product: Nov 20, 2020
Product: Nyvepria (biosimilar, pegfilgrastim)
Product: Nov 23, 2020
Product: Byvasda (biosimilar, bevacizumab)
Published: Nov 23, 2020
Product: Sulinno (biosimilar, adalimumab)
Product: Nov 25, 2020
Product: Biosimilar
Bio-Thera Reported MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin
Product: Nov 26, 2020
Product: BAT1706 (a proposed biosimilar to Avastin)
Related Post: Insights+ Key Biosimilars Events of October 2020
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Click here to read full press release/ article | Ref: PRNewswire | Image: Wikipedia
The post AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~0M first appeared on PharmaShots.
Click here to read full press release/ article | Ref: PRNewswire | Image: The New York Times
The post AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol first appeared on PharmaShots.
AstraZeneca is to sell European rights to its cholesterol drug Crestor (rosuvastatin) to Germany’s Grunenthal.
Crestor is a statin and at its peak generated annual revenues of more than $7 billion but it lost patent protection in the US four years ago and sales have tumbled.
Grunenthal will pay $320 million up front for rights to Crestor and associated medicines in over 30 countries in Europe, except for the UK and Spain.
The German pharma could also make milestone payments of up to $30 million and the deal is expected to be completed in the first quarter of 2021.
AZ will continue to manufacture and supply Crestor to Grunenthal during a transition period. AstraZeneca will also continue selling the medicine in other countries, including those in North America, Japan, China and other emerging markets.
AZ has a strategy of selling off its older drugs and reinvesting the proceeds in its research pipeline.
This has helped the company overcome one of the worst patent cliffs in the industry as Crestor and several other blockbusters encountered generic competition.
Income arising from the upfront and future payments will be reported in AstraZeneca’s financial statements within other operating income and expense.
The divestment will not impact the company’s financial guidance for 2020.
Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, said: “This agreement supports the management of our mature medicines to enable reinvestment into the pipeline and bringing new, innovative treatments to patients.
“Grunenthal previously acquired the rights to several established AstraZeneca medicines and is well placed to ensure continued access to Crestor for patients across Europe.”
Crestor is a lipid-lowering medicines and is used to treat blood disorders and to prevent cardiovascular events such as heart attacks and strokes.
It produces its lipid modifying effects in two ways: it blocks an enzyme in the liver causing the liver to make less cholesterol, and it increases the uptake and breakdown by the liver of cholesterol already in the blood.
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Click here to read full press release/ article | Ref: PRNewswire | Image: ABC News
The post AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure first appeared on PharmaShots.
Concerns around the efficacy of the Oxford University/AstraZeneca coronavirus jab in older people could lead to different age groups being given different vaccines, experts have said.
The partners announced last week that the vaccine had a 70% efficacy overall. For most trial participants – given two full doses, spaced a month apart – the efficacy was 62%, but for 3,000 participants mistakenly given half a dose for their first jab, the efficacy was 90%. No participants, regardless of dosing, developed severe Covid or were hospitalised with the disease.
AstraZeneca is to run an additional global trial to test its COVID-19 vaccine at a lower dosage, as the UK regulator begins to review trial data.
The shot, known as AZD-1222, developed in partnership with Oxford University, has dominated the pharma news agenda this week after it hit efficacy targets but appeared short of rivals from Pfizer and BioNTech.
With an overall efficacy of 72%, below the 95% seen with rivals, AZ’s vaccine would have been even weaker had it not been for a stronger potency seen in patients accidentally treated with a half dose followed by a full dose.
Now CEO Pascal Soriot wants to conduct a new test to confirm the 90% efficacy rate of the lower dose regimen, which was stumbled upon because of a manufacturing mistake.
The companies did not disclose the error at the time and there are concerns over their transparency, Bloomberg news reported.
Soriot told Bloomberg: “Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study.”
This will likely be another international study but could be faster as it will require fewer patients due to the higher efficacy seen with the revised dosing regimen.
The additional trial is unlikely to hold up regulatory approvals in the UK and EU, according to Soriot.
Health secretary Matt Hancock has asked the UK’s regulator the Medicines and Healthcare products Regulatory Agency (MHRA) to begin its review of the vaccine.
The Department of Health and Social Care said the UK could be one of the first in the world to receive the vaccine if authorised.
AZ is set to have up to 4 million doses ready for the UK by the end of the year and 40 million by the end of March.
The government also has pre-ordered 40 million doses of the Pfizer/BioNTech vaccine, which could be more than 90% effective but is harder to store and distribute as it needs to be kept extremely cold to retain its integrity.
The post AZ mulls trial of new COVID-19 vaccine dose as UK regulator begins review appeared first on .
AstraZeneca may have tried a positive spin on the trial mistake that led to the accidental discovery of the low dose COVID-19 vaccine regime with the highest efficacy– but the revelation has drawn a mixed response from commentators.
The company’s share price has tumbled since the announcement of the trial results from AZD-1222 at the beginning of the week, reflecting an overall loss of confidence in the company’s handling of the trial.
This was also reflected in numerous press reports that called into question the strength of the findings, particularly in the smaller group of patients who were given the lower dose.
As pointed out by the New York Times, there were fewer than 2,800 volunteers who got the more effective dose, which was accidentally given at half strength followed by a full strength dose 28 days later.
There were more than 23,000 participants in the data from the UK and Brazil, and the numbers used to calculate efficacy are lower than those used by rivals such as Moderna and Pfizer/BioNtech to calculate efficacy.
Pfizer tested its vaccine on more than 43,000 people and Moderna based its findings on more than 30,000 patients.
And then there’s the question of the deviation from the trial protocol that AZ’s research chief Mene Pangalos admitted to earlier this week.
After realising several thousand volunteers had accidentally received the wrong dose, Oxford University academics running the trial decided to press on regardless with the weaker dosing regime, breaking with the predetermined design.
As pointed out by Canada’s CBC, the change was okayed by regulators but nevertheless the stronger effect could still be a statistical quirk.
There was another confounding factor in that none of the people in the low-dose group were more than 55 years old.
Younger people would tend to produce a stronger immune response than older people, which could account for the differing results.
The decision to pool results and give a composite figure from the two dose strengths is another factor that is causing concern.
Moncef Slaoui, who leads the US COVID-19 vaccine programme Operation Warp Speed has told reports that his team are trying to determine what immune response the vaccine produced.
A separate study being conducted in the US may be modified to include the half-dose followed by a full strength booster, said Slaoui, who used to be GlaxoSmithKline’s vaccines chief.
Many reports point out that AZ’s shot has an advantage in that it can be stored in fridges instead of at the ultra-cool temperatures required by those from Moderna and Pfizer.
But trial results from these mRNA-based rivals seem to be much cleaner and could pave the way to faster decisions from regulators, which could be due in the next few days.
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After a gruelling year of successive waves of Covid-19 infections and national lockdowns there has been a burst of good news this month, with three separate vaccine candidates performing extremely well in clinical trials.
First, Pfizer and Moderna announced that their vaccines were testing at an efficacy of around 95%. Then came the news that the AstraZeneca vaccine (the one pre-ordered in bulk by the UK government) was hitting 90%. It marks not just a new phase in the Covid-19 pandemic but potentially a revolution in vaccine technology itself.
The developer of Russia’s COVID-19 vaccine Sputnik V has pledged to make it available for less than $10 per dose – or $20 per two-dose course – on the same day as revealing new clinical data with the shot.
Sputnik V’s efficacy has remained high at 91.4% according to the latest analysis, which comes from almost 19,000 subjects who were assessed seven days after the second dose of the vaccine, administered 28 days after the first.
Preliminary data from a smaller group of patients 21 days after the second shot suggests an efficacy of 95%, according to a press release from the Gamaleya Institute and Russian Direct Investment Fund (RDIF).
That puts the efficacy of the adenovirus-based vaccine ahead the 70% overall efficacy seen with AstraZeneca/University of Oxford’s AZD1222 jab – also based on an adenoviral vector – although AZ said yesterday there was a protective efficacy of 90% among patients receiving the vaccine as a half dose, followed by a full dose at least one month later.
AZ’s trial also had a higher number of confirmed cases of COVID-19 to power the analysis, at 131 cases, while there were 39 cases in the Russian study by the latest data cutoff. The next analysis for Sputnik V will be made when there are 78 confirmed coronavirus cases.
Sputnik V’s developers say its high level of efficacy comes from the use of two different adenoviral vectors which “allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.”
At the moment scientists only have the top-line data from press releases to go on so it is impossible to make any judgments about the relative efficacy of the two vaccines, or indeed the two mRNA-based shots from Pfizer/BioNTech and Moderna that have also shown efficacy rates above 90% in clinical trials.
The RDIF has echoed the position voiced by AZ that its adenoviral vaccine will be cheaper than the mRNA shots – by two to three times – and also has the advantage of being stored using regular refrigeration temperature of +2 to +8 degrees Celsius.
Pfizer and Moderna’s vaccines require much lower temperatures to prevent their active ingredients from breaking down.
“Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates,” it said.
Russia will provide Sputnik V to its domestic population free of charge, so the $10 per dose price applies to international markets.
Capacity to make the vaccine is currently enough to immunise 500 million people per year, and the first international deliveries will be made to customers in January. Other orders will start to be fulfilled from March.
Russia approved Sputnik V in August, making it the first coronavirus vaccine worldwide to be licensed worldwide.
So far it has accepted orders for 1.2 billion doses from more than 50 countries, including Brazil, India, Mexico and Hungary – the latter deal reportedly putting the EU member state at odds with the European Commission as Sputnik V hasn’t yet been approved by the EMA.
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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.
The world is moving a step closer to ending the coronavirus pandemic, the scientist behind Britain’s first vaccine has declared, as Boris Johnson said he hoped the majority of those most at-risk could be immunised by Easter.
Successful trial results for the Oxford University/AstraZeneca vaccine, suggesting it could protect up to 90% of people, are the third set of promising findings in as many weeks. Before this year, there had never been a vaccine for a coronavirus.
The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:
The stock market is cruel. AstraZeneca’s reward for unveiling promising data for its “vaccine for the world”, developed in partnership with Oxford University, was a 3.8% fall in its share price. No gratitude there – just a decline of roughly £4bn in the company’s value.
Investors have to react somehow, but the strong response looks odd. AstraZeneca, remember, has pledged to distribute the vaccine at cost during the course of pandemic. For the purposes of that pledge, it’s a little vague who decides when the pandemic is over. But it has always been reasonably clear that AstraZeneca won’t make profits from the initial orders that have been received from governments and international bodies. So the day when the company can move to a for-profit model (with supplies to poorer nations remaining at cost) is still some way off.
The Oxford vaccine is likely to be the first Covid jab that large numbers of Britons receive, despite Pfizer’s candidate already being analysed by the medicines regulators, experts say.
The fact that the Oxford vaccine can be kept in normal fridges, whereas Pfizer’s product has to be stored at -75C , may see it enter widespread usage ahead of the latter.
The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:
Dan McAteer describes his reaction more as a sense of relief than elation when his phone pinged on Monday morning with a push alert reporting that the Oxford AstraZeneca vaccine has up to 90% efficacy.
Several months on from becoming one of thousands of volunteers in trials of the Covid-19 vaccine, the 23-year-old student is trying to comprehend the news that people could be vaccinated as early as next month
Related: Oxford AstraZeneca Covid vaccine: everything we know so far
Click here to read full press release/ article | Ref: AstraZeneca | Image: NBC News
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The efficacy of the Oxford University/AstraZeneca vaccine opens the way for a cheap and more easily transportable vaccine to be made available to some of the world’s poorest countries.
Unlike the Pfizer-BioNTech vaccine, AstraZeneca’s experimental vaccine is already a part of Covax, the global initiative which hopes to distribute some 2bn doses to 92 low- and middle-income countries at a maximum cost of $3 a dose.
Related: Latest vaccine success is good news but high price may restrict access
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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Regeneron’s antibody cocktail is the latest COVID-19 drug to receive Emergency Use Authorization in the US, becoming the first therapy of this kind to become available.
The cocktail of casirivimab and imdevimab is still being investigated in trials but the FDA has enough data to grant a temporary licence while the pandemic continues.
Formerly known as REGN-COV2 or REGEN-COV2, the cocktail can be used for mild to moderate COVID-19 in adults and children at least 12 years of age and weighing at least 40 kg.
Doctors now have another option to choose from to combat the disease, following EUAs for drugs such as Eli Lilly’s baricitinib and Gilead’s Veklury (remdesivir).
To be eligible for Regeneron’s combination, patients must have received positive results of direct SARS-CoV-2 viral testing and be considered at high risk for progressing to severe COVID-19 and/or hospitalisation.
Clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.
As part of the Operation Warp Speed project to rapidly develop therapies and vaccines against the disease, the US government and Regeneron a supply agreement for the cocktail, which was famously used to treat president Donald Trump after he became infected.
Regeneron will coordinate with state authorities to allocate the cocktail on a weekly basis, based on prevalence of the disease in each state.
The first 300 doses will be provided at no cost to patients, although hospitals and clinics may add their own fees.
AmerisourceBergen will be the first national distributor to begin delivering the therapy.
Earlier this month, Regeneron had to modify a trial protocol for the therapy after independent safety experts said it should not be given to high-risk patients after an undisclosed safety issue emerged in testing.
In late October, Eli Lilly said it wouldn’t resume a trial of its rival antibody therapy in hospitalised patients after National Institutes of Health researchers said it wouldn’t help.
AstraZeneca is developing a long-acting antibody therapy combination in the US and other countries to prevent infection happening and as a therapy for those already infected.
Regeneron’s antibodies were designed to combat SARS-CoV-02 using the company’s proprietary genetically modified mice, which have been engineered to have a human immune system.
The antibodies bind non-competitively to the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population.
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In the 1960s, academics studying rumours drew inspiration from epidemiology. They noted how such stories spread through communities, “infecting” some individuals while others seemed immune, and how more resistant populations could stop their spread.
Their insights have in turn been taken up by health professionals. Hearsay can be useful, helping to catch disease outbreaks. It can also be deadly. Though vaccine hesitancy is as old as vaccines themselves, it has risen sharply in many countries in recent years. Unfounded scare stories about the safety of immunisation programmes have contributed to growing scepticism and outright refusal, with fatal consequences. In her new book Stuck: How Vaccine Rumours Start – and Why They Don’t Go Away, Prof Heidi Larson notes the paradox: we have better vaccine science, more safety regulations and processes than ever before, yet a doubting public.
Major trials will begin this weekend of an antibody cocktail that scientists hope will protect people against Covid-19 and could be swiftly used in care homes or on cruise ships in the event of an outbreak.
A UK volunteer will be given the first dose of a drug that is expected to give vulnerable people immediate protection. The jab into the muscle of the arm takes effect straight away and could last for six months to a year. If it works as well as scientists predict, it could be used to protect those who cannot be given vaccines because of their state of health.
The coronavirus vaccine being developed by Oxford University and AstraZeneca produces a strong immune response in higher risk older patients, a study has found.
The phase 2/3 trial results published in The Lancet about the UK-developed shot follow more detailed findings from Pfizer/BioNTech showing that their vaccine protected 94% of adults over 65 years old.
Although both vaccines are not yet approved by regulators, the results are encouraging as older people seem to be most at risk from the virus.
The results from the UK-developed vaccine, codenamed AZD1222, come from a trial in 560 healthy adult volunteers.
Results from the phase 2 component of the trial were published ahead of phase 3 data expected in the coming days or weeks, which will provide a much clearer picture about the vaccine’s safety and efficacy.
Those taking part were assessed to see if they were fit and healthy enough to take part before being assigned to receive either an intramuscular injection of the coronavirus vaccine or a control vaccine.
Booster regimes were given 28 days apart and dosing regimen varied according to age group.
Findings showed that the vaccine, which is based around a weakened chimpanzee cold virus, produced a similar immune response across all age groups and was better tolerated in older adults than in younger adults.
Regulators in the UK and Europe have begun rolling reviews of several coronavirus vaccines, including the Oxford vaccine, but these results will not be enough for them to fully assess its safety and efficacy.
The data needed for that will come from the larger phase 3 trial, which will be reviewed quickly by the regulators in real-time under the rolling review to hasten a decision.
Separate results published by Pfizer yesterday show the vaccine it is developing with Germany’s BioNTech protect around 94% of adults over 65 years old.
The trial involved 41,000 people worldwide, half of whom received the vaccine, with the remainder given a placebo.
These latest figures from the older age group are an improvement on the 90% overall efficacy figures announced in top-line results earlier this month.
Pfizer is reportedly close to filing results with the FDA for an Emergency Use Authorization after gathering the required amount of safety data.
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A second coronavirus vaccine candidate was always likely to struggle to match the excitement of the first, at least in stock market terms. Sure enough, Moderna’s promising trial results merely added to the generally bullish mood in markets without generating the same sense of wild relief, and 5% rise in the FTSE 100 index, that Pfizer and BioNTech achieved a week ago.
But, actually, the key difference with Moderna’s version looks significant. It’s the fact the company says its vaccine can be transported and stored for up to six months at -20C and will then remain stable for 30 days at fridge temperatures. By contrast, Pfizer and BioNTech spoke about -75C in storage and then only five days of stability in conventional fridges.
Hopes are rising for the Covid jab being developed by Oxford University, after Moderna became the second company to reveal impressive results from its vaccine trials.
Interim results from phase 3 clinical trials of the Covid vaccine from US company Moderna has revealed it to be almost 95% effective at preventing the disease. The news followed an announcement last week from Germany-based Pfizer and BioNTech that their vaccine was more than 90% effective.
The news that joint efforts by the US pharmaceutical company Pfizer and the German biotech company BioNtech have produced a vaccine that is 90% effective at protecting people from Covid-19 has been understandably applauded – in spite of the caveats. Pfizer states that it can manufacture up to 50m doses by the end of 2020 and up to 1.3bn doses in 2021.
Given the desire to get life back to normal, these doses will be in incredibly high demand. Some governments around the world, including the UK, have already begun to indicate to their populations that they will receive a vaccine by Christmas. But how will the distribution of this finite number of vaccines work when we only have enough for one seventh of the global population?
Related: Pfizer and BioNTech’s vaccine poses global logistics challenge
Clare Wenham is assistant professor of global health policy at the LSE. Mark Eccleston-Turner is a lecturer in Global Health Law at Keele University
Drug discovery firm Exscientia has beefed up its leadership team with the appointment of former AstraZeneca scientist Dr Garry Pairaudeau as its chief technology officer.
Pairaudeau – who will report directly to Exscientia chief executive Prof Andrew Hopkins – has been at AZ for 25 years, most recently as head of hit discovery with a brief covering high-throughput screening and virtual screening, computational chemistry, machine learning, and DNA-encoded libraries.
He also served as chair of AZ’s Global Chemistry Leaders Network, with responsibility for implementing strategic initiatives and collaborations, and championed developments in artificial intelligence (AI), machine learning, physics-based computation and automation.
Pairaudeau joins Exscientia at a fertile time for the UK biotech, which specialises in applying artificial intelligence to the drug discovery process and reckons its approach can carve up to 75% off the time it takes to find preclinical candidates.
The company hit the headlines earlier this year when it started clinical trials of the first drug molecule invented entirely using AI – a potential treatment for obsessive-compulsive disorder (OCD) partnered with Sumitomo Dainippon Pharma.
It then built on that success with a $60 million third-round financing in May – led by Novo Holdings – which is being used to build out its drug pipeline.
At Exscientia, Pairaudeau will be responsible for making sure Exscientia becomes “the most efficient drug discovery organisation in the world.”
Among his past achievements was the Malcolm Campbell award from the Royal Society of Chemistry (RSC), which he shared with other scientists for the discovery of Brilinta (ticagrelor), AZ’s blockbuster antiplatelet medication which is used with aspirin to lower a patient’s chance of having another heart attack, stroke or blood clot.
“Garry has forged a long-standing impressive career that has combined real-life drug hunting with cutting edge computational and AI techniques as well as robotics”, said Hopkins.
He added that the new CTO “has the rarest of talents of both a deep understanding of the problems of drug discovery and a drive to lead the development of new AI and automation approaches to solve those problems.”
Interest in using AI and machine learning to boost efficiency of drug discovery and development has been rising as the biopharma industry is facing declining returns on investment, and desperately needs more efficient R&D methods to boost productivity.
The global market for AI in healthcare was worth $2.1 billion in 2018, with exponential growth to $36 billion predicted by 2025, at a combined annual growth rate of 50.2%, according to a recent report by finnCap.
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Click here to read full press release/ article | Ref: AstraZeneca | Image: The Indian Express
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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.
Click here to read full press release/ article | Ref: AstraZeneca | Image: Pinterest
The post AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack first appeared on PharmaShots.
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AstraZeneca has posted an uninspiring set of quarterly results as it gears up for results from its closely watched coronavirus vaccine trial.
AZ said in its third quarter results statement that it is on track to meet its guidance for the year, with total revenue expected to grow by 8%-12% and core earnings per share increasing by 15%-19%.
In the three months to the end of September AZ’s revenue increased by 3% to $6.6 billion, with products sales up 6%.
Earnings per share fell to $0.94, missing analysts’ estimates of $1, as some patients held off treatments for ailments unrelated to COVID-19.
AZ has pursued a strategy of selling off its older or unwanted drugs and has been benefiting from “collaboration revenue” from these deals as development partners reach certain milestones.
This revenue fell by 79% to $58 million compared with the same quarter last year, although the company said that this was down to a strong performance in last year’s Q3.
The company suggested that collaboration revenue may be higher in the next quarter as this income tends to come in chunks as various research projects reach fruition or sales targets are met.
At the same time the company also grabbed two new European approvals – for Lynparza in castration-resistant prostate cancer and for Forxiga for a form chronic heart failure.
The company’s coronavirus vaccine is perhaps the company’s most eagerly-watched pipeline asset, although AZ is unlikely to make much money from it – at least until the worst of the pandemic is over.
As reported by pharmaphorum earlier this week, AZ expects results from its late-stage trial by the end of the year despite a safety scare in September, setting up approval by regulators early in 2021.
AZ has pledged to sell the vaccine at cost price until a cut-off point expected midway through next year.
But as the UK heads for another economically damaging month-long lockdown the company confirmed that it could have crucial phase 3 data from the vaccine by the end of the year.
If approved the vaccine will do little for the company’s figures but will create huge goodwill as governments across the world seek an end to the spiral of death caused by the coronavirus.
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An experimental gene therapy developed by Texas biotech Genprex will be paired with AstraZeneca’s Tagrisso and Merck & Co’s Keytruda – both leading their respective drug classes in the treatment of non-small cell lung cancer (NSCLC).
The two phase 1/2 trials are zeroing in on NSCLC patients with specific molecular biomarkers, to see if adding Genprex’ Reqorsa (quaratusugene ozeplasmid) – which delivers a gene that suppresses tumour growth – can enhance the activity of the AZ and Merck drugs.
The first trial, called Acclaim-1, will pair EGFR inhibitor Tagrisso (osimertinib) with Reqorsa as a second-line treatment for EGFR-mutated NSCLC patients whose cancer has progressed after first-line Tagrisso treatment.
The Acclaim-2 trial meanwhile will add Reqorsa to PD-1 inhibitor Keytruda (pembrolizumab) in NSCLC patients with PD-L1 expression levels of 1% to 49%, according to the partners. Both studies are due to start in the first half of next year.
Tagrisso is the top-selling EGFR inhibitor, with sales of almost $3.2 billion last year, while Keytruda dominates the market for cancer immunotherapies for NSCLC, accounting for a large chunk of its $11 billion-plus 2019 sales tally.
If positive, the trials would allow Reqorsa to piggyback on that success – assuming it makes it to market. So far, Genprex only has data for the therapy from two phase 1 trials, and part of a phase 2 study showing preliminary evidence of safety as well as efficacy in NSCLC.
Genprex’ therapy takes the form of a copy of the TUSC2 gene in a non-viral lipid nanoparticle formulation, delivered via an intravenous infusion, and was originally developed at the University of Texas’ MD Anderson Cancer Centre in the US.
After infusion, the nanoparticles are taken up by tumour cells, says Genprex, and leads to the expression of the TUSC2 gene into a protein that reprograms them to die.
In preclinical studies, the gene therapy also seems to block mechanisms involved in drug resistance, including TIM3, a bypass pathway that can lead to failure of PD-1-based therapy.
The FDA awarded fast-track status to the Tagrisso/Reqorsa for the treatment of EHGFR-mutated NSCLC earlier this year, as nearly all patients receiving AZ’s drug eventually experience disease progression.
According the company’s data, the median time to progression after first-line Tagrisso is about 18 months.
Austin-based Genprex has been preparing for the Reqorsa clinical trials programme, over the last few months, ramping up its manufacturing capacity for the gene therapy via an agreement with contract manufacturing organisation (CMO) Aldevron.
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Click here to read the full press release/ article | Ref: Fusion Pharmaceuticals | Image: Moffitt
The post AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer first appeared on PharmaShots.
COVID-19 vaccines could be approved and available early next year in the UK ahead of European countries, after its national regulator began its own rolling reviews of shots from AstraZeneca and Moderna.
AstraZeneca has confirmed that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has begun a fast-track rolling review of its AZD1222, the COVID-19 vaccine it developed in conjunction with Oxford University.
This followed last week’s news that the MHRA has begun a parallel rolling review of a rival from Moderna.
The rolling review allows for a real-time assessment of the clinical data from clinical trials, accelerating a process that normally takes around a year to complete using the centralised European regulatory system.
Using the MHRA could allow the UK to make regulatory decisions on COVID-19 vaccines ahead of the European system, where medicines and vaccines are first reviewed by the CHMP scientific committee before being passed on to the European Commission.
But a source close to process told pharmaphorum that it is “eminently possible” that the MHRA could reach its conclusions ahead of its European counterparts as the country reaches the end of the Brexit transition period.
A spokesperson for the MHRA said that from 1st January, it will have new powers to approve medicines, including vaccines including “greater flexibility to do this faster, while maintaining the highest standards of safety, quality and effectiveness.”
The spokesperson said: “The MHRA will evaluate the data rigorously on the quality, safety and effectiveness of COVID-19 vaccines to reach a scientifically robust independent opinion if an earlier authorisation is necessary before the EMA (European Medicines Agency) authorises a product.”
“Patient safety is our top priority. The independent Commission on Human Medicines will advise the UK government on the safety, quality and effectiveness of any potential vaccine. No vaccine will be deployed in the UK unless stringent standards have been met through a comprehensive clinical trial programme”
Representatives of the MHRA used to sit on the CHMP but no longer participate as a result of Brexit, leaving the UK to make its own decisions on medicines regulation should it choose to do so.
According to the source, COVID-19 vaccines could be available in early January depending on the length of time it takes for trial data to be published and shared with regulators.
COVID vaccines are being developed at warp speed, with the development and review process that normally takes up to a decade to complete compressed into less than a year after research began at the end of January.
The MHRA’s approach to the AZ and Moderna vaccines also paves the way for similar fast reviews to rivals from the likes of Pfizer/BioNTech and Novavax, which the UK government also has on order and are reaching the end of the clinical trial process.
The news comes as the country prepares for another national lockdown, which will disrupt business and limit people’s freedoms for at least another month.
A vaccine is seen as a potential way out of the cycle of lockdowns that have already caused severe hardship across the UK, which is one of the countries worst hit by COVID-19.
An AstraZeneca spokesperson told pharmaphorum: “Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the communities where the clinical trials are being conducted. It is then up to the regulatory bodies to review and make approval decisions based on this data, as quickly as possible.
“The EMA announced in October that its CHMP had started a ‘rolling review’ of data for AZD1222, the first COVID-19 vaccine to be evaluated under these arrangements. We confirm the MHRA’s rolling review of our potential COVID-19 vaccine.”
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Novavax Initiated P-III Study of its COVID-19 Vaccine in the UK
Date – Sept 25, 2020
Product – NVX-CoV2373
J&J Initiated Global P-III Clinical Study of its COVID-19 Vaccine
Date- Sept 24, 2020
Product- JNJ-78436735
Illumina Acquired GRAIL for ~$8B
Date – Sept 22, 2020
Deal Value – ~$8B
Fitbit to Launch ECG App in the US and EU in October 2020
Date – Sept 15, 2020
Product – ECG App
Date – Sept 15, 2020
Product – Beovu (brolucizumab)
Gilead Acquired Immunomedics for ~$21B
Date – Sept 14, 2020
Deal Value – ~$21B
Merck Signed Up to $4.5B Oncology Deal with Seattle Genetics
Date – Sept 14, 2020
Deal Value – ~$4.5B
Date – Sept 11, 2020
Product – Kisqali (ribociclib)
AbbVie Licensed I-Mab’s Lemzoparlimab (TJC4) for ~$2B
Date – Sept 09, 2020
Deal Value – ~$2B
Date – Sept 07, 2020
Product – Gavreto (pralsetinib)
Date- Sept 01, 2020
Product- AZD1222
GSK and VIR Biotechnology Initiated P-II/III COMET-ICE Study of VIR-7831 Against COVID-19
Date- Sept 01, 2020
Product- VIR-7831
World’s First App-Based Nicotine Addiction Treatment Received the MHLW’s Approval in Japan
Date – Aug 31, 2020
Product – CureApp
GSK’s Blenrep (belantamab mafodotin) Received EC’s Approval for R/R Multiple Myeloma
Date – Aug 27, 2020
Product – Blenrep (belantamab mafodotin-blmf)
Date – Aug 21, 2020
Product – Kesimpta (ofatumumab)
Johnson & Johnson Acquired Momenta Pharmaceuticals for $6.5B
Date – Aug 19, 2020
Deal Value – ~$6.5B
Sanofi Acquired Principia Biopharma for ~$3.68B
Date – Aug 17, 2020
Deal Value – ~$3.6B
Zydus Launched Cheapest Version of Remdesivir at $37.41 per Vial in India
Date – Aug 13, 2020
Product – Remdesivir
Biogen Signed an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B
Date – Aug 07, 2020
Deal Value – ~$2.125B
Siemens Healthineers Acquired Varian for $16.4B
Date – Aug 04, 2020
Deal Value – ~$16.4B
Sanofi and GSK Received $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine
Date – Aug 03, 2020
Value – $2.1B
Date – Jul 29, 2020
Product – Actemra/RoActemra (tocilizumab)
Roche and UCB Collaborated to Develop UCB0107 for Alzheimer’s Disease
Date- Jul 29, 2020
Deal Value- ~$2B+
Date – Jul 27, 2020
Deal Value – ~$6B
Sanofi Signed an Agreement with Kymera to Advance Novel Protein Degrader Therapies Worth Up to $2.1B
Date – Jul 10, 2020
Deal Value – ~$2.1B
Bausch Health Spun off its Eye Health Business
Date – July 08, 2020
Product – N/A
Date – Jul 07, 2020
Deal Value – ~$1B
Date – Jul 01, 2020
Product – Bavencio (avelumab)
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Click here to read full press release/ article | Ref: AstraZeneca | Image: Pharmaceutical Technology
The post AstraZeneca’s Forxiga (dapagliflozin) Receive NMPA’s Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study first appeared on PharmaShots.
One of the world’s leading Covid-19 experimental vaccines produces an immune response in both older and young adults, raising hopes of a path out of the gloom and economic destruction wrought by the novel coronavirus.
The vaccine, developed by the University of Oxford, also triggers lower adverse responses among elderly people, said the British drug maker AstraZeneca, which is helping to manufacture the vaccine, on Monday.
Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?
Related: At 75, I’ve volunteered for a Covid vaccine trial. It could set people free
Bayer’s blockbuster ambitions for diabetic kidney disease (DKD) drug candidate finerenone look a lot firmer with the publication of data from the phase 3 FIDELIO-DKD trial.
Bayer teased the top-line result from the study back in July, providing the first clue that its sizeable investment in the finerenone programme could pay off, but kept the data under wraps other than to say the drug met the dual objectives of reducing renal and cardiovascular events in patients with type 2 diabetes and chronic kidney disease.
Now, the 5,734-patient study has been presented at the Kidney Week 2020 congress and simultaneously published in the New England Journal of Medicine, and the data look solid.
A second ongoing phase 3 trial – called FIGARO-DKD – is concentrating primarily on cardiovascular endpoints but also includes aptietnsd with earlier-stage kidney disease and has a read out due next year.
Bayer is eyeing regulatory filings before the end of 2020 on the back of the FIDELIO-DKD results, which would set up a clash with SGLT2 inhibitors, drugs for diabetes that are also emerging as promising therapies for DKD.
That includes Johnson & Johnson’s Invokana (canagliflozin) – already approved for diabetic kidney disease – as well as AstraZeneca’s Farxiga (dapagliflozin) which showed positive results in the DAPA-CKD trial in both diabetic and non-diabetic subjects just last week.
Finerenone – billed as a first-in-class non-steroidal, selective mineralocorticoid receptor (MR) antagonist – reduced the risk of kidney disease progression or renal death by 18% when added to the highest tolerated dose of standard therapy in FIDELIO-DKD.
The drug also cut cardiovascular outcomes – including death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke or hospitalisation for heart failure – by 14%.
“Overactivation of the mineralocorticoid receptor contributes to inflammation and fibrosis in the kidneys and heart, which represents an unmet medical need,” said lead investigator Prof George Bakris of University of Chicago Medicine.
“The results with finerenone are highly relevant for these patients who currently have limited options,” he added.
There is also a huge number of them. Diabetes is the leading cause of kidney failure, and there are estimated to be almost 850 million people worldwide with chronic kidney disease (CKD).
If approved, finerenone would enter a market in which J&J is struggling to overturn the lingering impact of black-box warnings over amputation risks with Invokana that were dropped in the summer. The drugmaker sees kidney disease as its route to growth after a couple of years of declining sales, and is promoting the new use strongly.
AZ meanwhile is on a roll with Farxiga, with the new data in CKD building on recent data for the drug in heart failure that is helping to drive sales growth, although patent expirations and the threat of generic competition are looming.
Bayer is also eyeing a heart failure indication for finerenone, and now has a phase 3 trial in heart failure with preserved ejection fractions (HFpEF) in play that if successful would unlock a hitherto untapped market with no approved drugs.
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Click here to read full press release/ article | Ref: AstraZeneca | Image: NPR
The post AstraZeneca Presents Results of Farxiga (dapagliflozin) in P-lll DAPA-CKD Study for Chronic Kidney Disease at ASN Kidney Week 2020 first appeared on PharmaShots.
US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot.
Separately, Johnson & Johnson has also announced it is resuming recruitment in a phase 3 trial of its coronavirus candidate JNJ-78436735, which has also suspended after one study subject fell ill.
AZ confirmed the FDA’s move in a statement, saying that regulators in the US, UK, Brazil, South Africa and Japan have now said that trials of the Oxford University-partnered shot are safe to continue.
The FDA took a lot longer to reach its conclusion however, as recruitment into studies restarted just a few days after the halt elsewhere.
AZ chief executive Pascal Soriot said: “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”
On 6 September, AZ said it had put trials of AZD1222 on temporary hold because of a potential safety issue involving one patient in the UK, who had become ill after taking the vaccine with what at the time was reported to be transverse myelitis – an inflammation of the spinal cord that can be associated with viral infections as well as neurological conditions like multiple sclerosis.
“It is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety,” said AZ, which hasn’t confirmed the nature of the adverse reaction.
A report in the Wall Street Journal suggests that the FDA has reviewed two cases of potential neurological side effects in patients receiving AZD1222. One was subsequently found to be in a patient with MS, but the US regulator couldn’t either identify or rule out a clear link to the vaccine in both cases.
A death has also occurred in a patient enrolled onto an AZD1222 study in Brazil, although that has not been linked to the vaccine and is believed to have occurred in a subject who did not receive the shot.
AZ is now expecting to have results from the trials before the end of the year – analysts at Jefferies think it could occur in mid-November – and rolling regulatory reviews of AZD1222 are already underway in some markets including the EU.
J&J meanwhile said that the independent data safety monitoring committee overseeing the phase 3 ENSEMBLE trial of JNJ-78436735 had found no clear cause behind a “serious medical event” – reported to be a stoke – in one subject that caused the study to be placed on hold earlier this month.
“After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified,” said the drugmaker in a statement indicating the findings had been shared with the FDA. “There are many possible factors that could have caused the event.”
The suspension of studies for AZD1222 and JNJ-78436735 has put two coronavirus vaccines from BioNTech/Pfizer and Moderna in the lead in the US, with top-line efficacy results due within the next 4-5 weeks, although safety data will take a little longer to come in.
The resumption of the two stalled studies means that AZ and J&J will now not be too far behind.
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Click here to read full press release/ article | Ref: AstraZeneca | Image: The Indian Express
The post AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US first appeared on PharmaShots.
AstraZeneca’s COVID-19 vaccine trial could be ready to resume this week in the US after a seven-week hiatus while the FDA completed its review of a serious illness, according to reports.
Citing four sources, Reuters said that the FDA is about to allow the large-scale trial of the shot to resume after it was put on hold on 6 September when a participant in the UK fell ill.
AZ has not confirmed the nature of the illness because of concerns over patient privacy, but according to press reports the person developed the rare spinal inflammatory disorder transverse myelitis.
Reuters said its sources were briefed on the matter but asked to remain anonymous but said the trial could resume later this week.
It is unclear how the FDA characterised the disease that caused the stoppage and the regulator has so far declined to publicly comment on the matter.
The FDA is requiring trial researchers to add information about the incident to consent forms signed by study participants, one of the sources told Reuters.
UK regulators allowed the trial to resume a week after it was put on hold – according to Reuters’ sources this was because there was “insufficient evidence to say for certain” that it was not related to the vaccine.
The Medicines and Healthcare products Regulatory Agency (MHRA) recommended that vaccinations should continue but with close monitoring of the affected person and other participants.
The FDA has publicly stated the importance of safety data for COVID-19 vaccines – they will be given to healthy individuals and there is very little tolerance for any side effects.
The regulator has said manufacturers must have at least two months’ worth of safety data before filing a COVID-19 vaccine, amid concerns that the Trump administration may attempt to rush approval ahead of the US election on 3rd November.
As Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, pointed out to Reuters, regulators have to weigh whether a rare side effect is vaccine-related and could occur again.
Transverse myelitis occurs at a rate of one in 200,000 people and he noted it would be unusual to see it in a trial of 9,000 people.
But other viruses including West Nile and polio can trigger the condition, as well as physical trauma.
Regulators in Brazil, India and South Africa have also allowed trials to resume.
Until the safety issue AstraZeneca had been a frontrunner in the race to produce a vaccine for COVID-19.
Johnson & Johnson has voluntarily put a trial of its potential rival vaccine on hold because of a safety issue.
According to the World Health Organization, there are 44 candidate vaccines in clinical trials, with three shots developed in China listed as most advanced followed by the AZ vaccine.
pharmaphorum has approached AZ for comment.
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Click here to read full press release/ article | Ref: AstraZeneca | Image: The Print
The post AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer first appeared on PharmaShots.
The FDA has granted a fast review for AstraZeneca’s Tagrisso oncology drug in certain patients with early-stage lung cancer.
Results from the phase 3 ADAURA trial were the talk of this year’s American Society of Clinical Oncology (ASCO) conference in summer and the regulator has granted a Priority Review for a label extension based on the results.
The FDA reserves these faster reviews, taking six months at the most instead of the standard ten-month timeframe, for medicines that demonstrate superior efficacy or safety for serious diseases.
ADAURA tested Tagrisso (osimertinib) in patients with early-stage (1B, II and III) epidermal growth factor receptor-mutated (EGFR) non-small cell lung cancer (NSCLC) after complete tumour removal.
Up to 30% of all patients diagnosed early with NSCLC in this patient group may be diagnosed early enough to have curative surgery, but disease recurrence is common and more than three quarters of patients diagnosed in Stage IIIA experience recurrence within five years.
ADAURA was halted early this year after Tagrisso showed “overwhelming efficacy” in this patient group.
In the trial Tagrisso reduced the risk of disease recurrence or death by 83% compared to placebo in patients with tumours that had spread locally but not to other parts of the body (stage II-IIIa), and who had surgery with the aim of completely removing the tumour and curing their cancer.
The drug also reduced disease-free survival by 79% in the overall trial population (stage 1b to IIIa), and after two years 89% of patients remained alive, compared to 53% of the placebo group.
It’s the first time that a targeted drug has shown an improvement in this group of patients in a large scale trial.
Approval will be another string in the bow for Tagrisso, which is already a blockbuster bringing in revenues of more than $1 billion per quarter for the UK pharma.
Tagrisso is a third-generation irreversible EGFR-tyrosine kinase inhibitor that was originally intended to treat patients with EGFR-mutated NSCLC after an older drug from that class has been rendered useless by a T790M mutation, which usually occurs after around 18 months of treatment.
But since this first FDA approval in 2015 it has also been licensed in first-line treatment in EGFR-mutated lung cancer, after outperforming AZ’s older EGFR drug Iressa (gefitinib) and Roche’s rival Tarceva (erlotinib) in the phase 3 FLAURA trial.
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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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Click here to read full press release/ article | Ref: AstraZeneca | Image: TeleTrader.com
The post AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat COPD first appeared on PharmaShots.
Even a once bullish PM is now not so optimistic but there are promising signs of a vaccine on the horizon
In March, Boris Johnson said we would turn the tide in 12 weeks and “send the coronavirus packing” and by May ministers were boasting of having a vaccine by September. Last week the prime minister sounded far less confident, telling MPs that there was still no vaccine for SARS, 18 years after it emerged. A vaccine may not be far away though.
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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Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec
Published: Oct 15, 2020 | Tags: Clinical, Trial, Galapagos, GLPG1972/S201086, Knee Osteoarthritis, Patients, P-II, Report, results, ROCCELLA, Servier
Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19
Published: Oct 15, 2020 | Tags: advance, Against, Clinical, Study, COVID-19, MRT5500, Sanofi, Translate, Bio
Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan
Published: Oct 15, 2020 | Tags: Chugai, Drug, First, Japan, MHLW, NDA, Oral, Report, Risdiplam, Spinal Muscular Atrophy
Published: Oct 15, 2020 | Tags: Adult, approval, KEYTRUDA, Merck, patients, pembrolizumab, receives, Relapsed Refractory cHL, US, FDA
Eli Lily to Acquire Disarm Therapeutics for ~$1.36B
Published: Oct 15, 2020 | Tags: ~$1.36B, Acquire, Disarm, Therapeutics, Eli Lily
Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to Safety Concerns
Published: Oct 14, 2020 | Tags: ACTIV-3, Clinical, Decision, Due, Eli Lilly, Enrollment, NIAID, Pause, Trial
Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil
Published: Oct 14, 2020 | Tags: Abivertinib Maleate, ANVISA, approval, COVID-19, Mild, P-II, patients, Proceed, receives, Severe, Sorrento, STI-5656, Trial
Published: Oct 14, 2020 | Tags: 1EP, Aliqopa, Bayer, copanlisib, Meets, patients, reports, results, Rituximab
Takeda Collaborates with Accenture and AWS to Transform into a Cloud-Based Company
Published: Oct 13, 2020 | Tags: Accenture, AWS, Cloud-Based Company, Collaborates, Takeda, Transform
Published: Oct 15, 2020 | Tags: approval, atoltivimab, Ebolavirus, First, Inmazeb, maftivimab, odesivimab, receives, Regeneron, Treatment, US, FDA
Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B
Published: Oct 14, 2020 | Tags: ~$1.8B, AVV, Gene, Therapy, Develop, Dyno, License, Agreement, Roche, Signs
Boehringer Ingelheim Presents Results of Gilotrif (afatinib) for NSCLC at IASLC NACLC 2020
Published: Oct 14, 2020 | Tags: 2020, Boehringer Ingelheim, Gilotrif, IASLC, NACLC, Report, Result
Moderna Initiates Rolling Submission to Health Canada for mRNA-1273 Against COVID-19
Published: Oct 14, 2020 | Tags: COVID-19, Health Canada, Moderna, mRNA Vaccine, mRNA-1273, Rolling Submission
Prestige’s PBP1510 Receives EMA’s Positive Opinion on Orphan Designation for Pancreatic Cancer
Published: Oct 14, 2020 | Tags: Designation, EMA, Opinion, Orphan, Pancreatic cancer, PBP1510, Positive, Prestige, receives
Celltrion Launch P-III Post-Exposure Prophylaxis Clinical Trial of CT-P59 for COVID-19
Published: Oct 14, 2020 | Tags: Anti, Candidate, Celltrion, Clinical Trial, COVID-19, CT-P59, Launch, mAb, P-III, Treatment
Published: Oct 14,2020 | Tags: Advanced Cancer, First Patients Dosing, KEYTRUDA, Linnaeus, LNS8801, pembrolizumab, reports
J&J Pauses Dosing in COVID-19 Vaccine Studies Due to Unexplained Illness
Published: Oct 14, 2020 | Tags: COVID-19, Dosing, J&J, Pauses, Unexplained Illness, Vaccine, Studies
Roche to Launch Elecsys SARS-CoV-2 Antigen Test for Suspected COVID-19 Patients
Published: Oct 13, 2020 | Tags: Antigen, COVID-19, Laboratory, Launch, patients, Roche, SARS-CoV-2, Suspected, Test
Published: Oct 13, 2020 | Tags: Asthma, attacks, Biologic, Children, children’s, Demonstrate, dupilumab, Dupixent, Function, Improvement, Lung, P-III Trial, Reduced, reports, results, Sanofi, Severe
Published: Oct 13, 2020 | Tags: Filgotinib, Galapagos, Gilead, P-2B/3, reports, results, SELECTION Study, Ulcerative Colitis (UC)
Lilly Reports Results of Mirikizumab in P-ll SERENITY Study for Crohn’s Disease
Published: Oct 13, 2020 | Tags: Crohn Disease, Improvement and Reduction of Intestinal Inflammation, Lilly, Mirikizumab, P-ll, reports, results, SERENITY Study
Published: Oct 13, 2020 | Tags: Active, During, Entyvio, Long-Term, Maintenance, Moderately, reports, results, Severely, Takeda, therapy, Vedolizumab
Abbott’s AdviseDx SARS-CoV-2 IgM Test Receives the US FDA’s EUA for COVID-19
Published: Oct 13, 2020 | Tags: Abbott, antibody, Authorization, Blood, Test, COVID-19, Emergency, IgM, New, receives, Test, U.S.FDA, Use
Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in China
Published: Oct 12, 2020 | Tags: Autoimmune Disease, Halpryza, Innovent, Lilly, NMPA Granted Marketing Approval, Rituximab
Published: Oct 12, 2020 | Tags: Five-Year, Janssen Pharmaceutical, LTE Study, P-lll, Report, results, Severe Crohn’s Disease, Stelara, ustekinumab
AstraZeneca Advances its AZD7442 in Two P-III Clinical Studies for COVID-19
Published: Oct 12,2020 | Tags: Acting, antibody, AstraZeneca, AZD7442, COVID-19, Long, P-III, Test, Treatment, Trials
Published: Oct 12,2020 | Tags: Active Crohn’s Disease, guselkumab, Interim, Janssen, P-II, patients, reports, Result, study, Tremfya
Published: Oct 12,2020 | Tags: Breast Cancer, German Breast Group, Ibrance, P-lll, Palbociclib, PENELOPE-B Study, Pfizer Inc., Report, results
Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in China
Published: Oct 10,2020 | Tags: Autoimmune Disease, Halpryza, Innovent, Lilly, NMPA, Granted, Marketing Approval, Rituximab
Related Post: PharmaShots Weekly Snapshot (Oct 5-9, 2020)
The post PharmaShots Weekly Snapshot (Oct 12-16, 2020) first appeared on PharmaShots.
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.
The post Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab appeared first on .
Shots:
Click here to read full press release/ article | Ref: NVIDIA | Image: Medsmart App
The post GSK and AstraZeneca Plan to Deploy NVIDIA’s Supercomputer for Drug Development first appeared on PharmaShots.
As European regulators begin a rolling review of AstraZeneca’s COVID-19 vaccine, the focus in the UK has shifted to the government’s plans to distribute any vaccine that is deemed to be a safe and effective way of preventing the disease.
According to weekend press reports a rollout of a vaccine could be just three months away – but the feedback from the government is that not everyone will get it, with the target group being around 30 million older people and health workers, less than half the population of 67 million.
Speaking to the Financial Times, the head of the country’s coronavirus vaccine task force Kate Bingham said that any vaccination programme will be targeted at the most vulnerable in society.
She said: “People keep talking about ‘time to vaccinate the whole population’ but that is misguided.
“There is going to be no vaccination of people under 18. It’s an adult-only vaccine for people over 50 focusing on health workers and care home workers and the vulnerable.”
The strategy will likely be based on a draft list published last month by the government’s Joint Committee on Vaccine and Immunisation (JCVI), showing who is likely to be first to receive the vaccine.
According to the JCVI a “simple age-based programme” will decide who gets priority, as this will allow the vaccine to get to those at highest risk at the fastest possible speed.
Older adults in care homes and care home workers would be in the first group, followed by those aged over 80, over 75, over 70 and over 65.
A sixth priority group would comprise of younger adults under 65 with conditions that leave them at high risk of developing serious complications from the virus.
They would be followed by those aged under 65 who have a moderate risk level.
Even distributing the vaccine to half the population will be a major logistical challenge, however, and the UK government is facing scrutiny and criticism over its handling of the pandemic so far.
Flaws in the coronavirus reporting system emerged over the weekend when it emerged that nearly 16,000 cases had been missed in daily figures over the last week or so because of an IT error.
The government has also been criticised for failing to implement a track and trace system early in the pandemic, a measure that limited its spread in other countries.
Health secretary Matt Hancock has already said that the military may be brought in to help distribute the vaccine.
Getting what could be the final stage of the fight against COVID-19 right will be vital if the government wishes to restore credibility, as millions continue to live under lockdown restrictions that have cost thousands of jobs and continue to damage the economy.
The post Older people first to receive COVID-19 vaccine in UK, says government appeared first on .
Shots:
Click here to read full press release/ article | Ref: AstraZeneca | Image: Mint
Related News: AstraZeneca Resumes COVID-19 Vaccine Trials in the UK
The post AstraZeneca Resumes Clinical Study of its COVID-19 Vaccine in Japan first appeared on PharmaShots.
European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford.
It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines Agency did not say how long the process will take.
Confirming press reports, the EMA said that large scale clinical trials from the vaccine codenamed AZD1222 involving several thousands of people are ongoing and results will become available over “the coming weeks and months”.
The rolling review, which is designed to speed up the assessment of a promising vaccine or drug by the EMA’s CHMP scientific committee, will continue until there is enough evidence available to support a marketing authorisation.
But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.
All that the agency has is preliminary data from pre-clinical and early clinical studies suggesting the vaccine triggers the production of antibodies and T-cells that target the virus.
In a separate announcement, AstraZeneca said that a trial of the vaccine has resumed in Japan after a safety scare in the UK.
Trials have already restarted in the UK, Brazil, South Africa and India after one patient in the UK developed a potential side-effect that was deemed serious enough to cause the trial to be paused.
Discussions are still ongoing with the FDA, which has asked for further information before making a decision about resuming a trial in the US.
AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.
It uses a replication-deficient chimpanzee viral vector based on a weakened version of an adenovirus that that causes common cold infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.
After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on .
Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.
Campaign scoring countries for global access efforts calls for more British transparency
The UK is doing more than most countries to support access to Covid vaccines for the poorest populations in the world, but it is not transparent enough about the deals it is doing at home, according to an international aid organisation launching a tracker.
The One campaign has given countries and pharmaceutical companies scores for the efforts they have made to ensure the poorest get vaccines. In the vaccine access test no country or company scores green, the top rating, classed as aiding global access to vaccines.
Trials of vaccine being developed with AstraZeneca had been paused after participant fell ill
The closely watched trial of an experimental Covid-19 vaccine that was halted after a participant fell ill is to resume in the UK.
The University of Oxford, which has partnered with pharmaceutical giant AstraZeneca to pilot the study, said that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) had recommended that its trials resume after an independent committee review of safety data triggered a pause last week.
Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?
Expert behind vaccine confidence report points to halting of Oxford Covid trial as example
Doctors and scientists need to show more empathy towards volunteers in coronavirus vaccine trials who fall ill if the public is to have full confidence in the safety of the vaccines being developed, say experts.
The temporary halting of the Oxford University/AstraZeneca trial after one volunteer in the UK was admitted to hospital was good news, not bad, said Heidi Larson, who leads the Vaccine Confidence Project at the London School of Hygiene and Tropical Medicine, as it showed that scientists and the company were putting safety first.
Pharmaceutical firm’s boss says 2020 deadline possible if regulators move fast
AstraZeneca’s coronavirus vaccine could still be available by the end of the year, or early next year, according to the company’s chief executive, Pascal Soriot, despite clinical trials being paused after a volunteer fell ill.
AstraZeneca and Oxford University, which are jointly developing the vaccine and testing it on 50,000 to 60,000 people around the world, halted trials on Wednesday to investigate the “potentially unexpected illness” of one participant.
Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?
Tests have been paused after a UK volunteer became ill. How will it affect the search for a cure?
One of the volunteers in the UK has become ill and it is crucial that the researchers find out whether this could be related to the vaccine. This is not uncommon in vaccine trials – and in fact it is said to be the second time it has happened with this vaccine . Very large trials are essential to pick up any rare side-effects. Something that affects one in 10,000 people, for instance, will probably not be detected in the early trials of just a few thousand.
A spokesman for AstraZeneca, the company working on the coronavirus vaccine, said pausing trials was common during vaccine development
The development of a promising Covid-19 vaccine has been put on hold due to a possible adverse reaction in a trial participant.
A spokesman for AstraZeneca, the company working with a team from Oxford University, told the Guardian the trial has been stopped to review the “potentially unexplained illness” in one of the participants.
Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?
Related: Let’s get real. No vaccine will work as if by magic, returning us to ‘normal’ | Jeremy Farrar
UK drugmaker and Oxford Biomedica to produce more of potential coronavirus product
AstraZeneca has expanded an agreement with Oxford Biomedica to scale up production of its potential Covid-19 vaccine, as the race continues to find an effective prevention for the deadly virus.
Under the supply agreement, the Oxford-based cell and gene therapy firm said it would produce tens of millions of doses of AstraZeneca’s potential vaccine, AZD1222, for 18 months, which could be extended by a further 18 months into 2023.
Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?
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
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
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
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
Published: Aug 24, 2020 | Tags: AbbVie, Exercises, License, Option, Morphosys, αvβ6 Integrin, Inhibitor Program, Fibrotic Disease
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
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
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
Published: Aug 23, 2020 | Tags: Chugai, Kadcyla, (trastuzumab emtansine), Receives, MHLW, Approval, Adjuvant Therapy, HER2-Positive, Early Breast Cancer
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
The US FDA has approved multiple NDAs and BLAs in July 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 59 novel products so far in 2020, including 8 in July 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 8 new drugs approved by the US FDA in July 2020.
Published: Jul 02, 2020 | Tags: Acacia Pharma, Byfavo, remimazolam, Received, the US FDA, Approval, Induction, Maintenance, Procedural Sedation
2. Osmotica’s Upneeq Received the US FDA’s Approval to Treat Blepharoptosis (Droopy Eyelid) in Adults
Published: Jul 09, 2020 | Tags: Osmotica, Upneeq, Received, the US FDA, Approval, Treat, Blepharoptosis, Droopy Eyelid, Adults
3. Otsuka Inqovi (decitabine and cedazuridine) Received the US FDA’s Approval to MDS and CMML
Published: Jul 20, 2020 | Tags: Otsuka, Inqovi, decitabine, cedazuridine, Received, the US FDA, Approval, MDS, CMML
Published: Jul 22, 2020 | Tags: Jazz Pharmaceuticals, Xywav, Calcium, magnesium, potassium, sodium oxybates, Received, the US FDA, Approval, Cataplexy, Excessive, Daytime, Sleepiness, Associated, Narcolepsy
5. MC2 Therapeutics Wynzora Cream Received the US FDA’s Approval to Treat Plaque Psoriasis in Adults
Published: Jul 22, 2020 | Tags: MC2 Therapeutics, Wynzora Cream, Received, the US FDA, Approval, Treat, Plaque Psoriasis, Adults
Published: Jul 24, 2020 | Tags: AstraZeneca, Breztri Aerosphere, Received, US, FDA, Approval, Maintenance Treatment, COPD
Published: Jul 31, 2020 | Tags: MorphoSys, Monjuvi, tafasitamab-cxix, Lenalidomide, Received, US, FDA, Approval, 2L, Treatment, Patients, Relapsed, Refractory, Diffuse Large B-cell Lymphoma
Published: Jul 31, 2020 | Tags: ViiV Healthcare, Rukobia, fostemsavir, Received, US, FDA, Approval, HIV, Patients, Limited Treatment Options
The drug, AZD7442, is designed to potentially provide at least six months of protection from Covid-19. The trial, which is funded by federal defense and health authorities in the U.S., is enrolling up to 48 healthy volunteers in the U.K. AstraZeneca’s double-antibody approach is similar to that of Regeneron and Roche with their drug, REGN-COV2.
AstraZeneca | Sizes of cities | Starlings | Mickey Mouse degrees | Passport photos
As a participant in the Oxford University Covid-19 vaccine trial, I’d be put out if AstraZeneca rushed through a deal with Donald Trump in time for the US presidential election (Oxford University Covid-19 vaccine firm says it is not in talks with Trump, 24 August). AstraZeneca must issue a less ambiguous rebuttal of the reports of such a deal. If it doesn’t, I’ll withdraw from the trial.
Paddy Clark
Chiddingfold, Surrey
• Britain’s most populous city in its own right is in fact Birmingham (Letters, 24 August). While Greater London is Britain’s biggest urban area, only the City of London and Westminster have city status. Manchester comes fourth (after Leeds and Sheffield), though this may depend on which boroughs you include – not Salford, surely?
Matthew J Smith
New Malden, London
The first patients have been dosed in a trial of two AstraZeneca antibodies, collectively known as AZD7442, that are being developed to both treat and prevent coronavirus infections.
The phase 1 trial – funded by the US government – will take place in the UK and will test the safety of AZD7442 and its pharmacokinetic profile. It will enrol up to 48 people aged 18 to 55, and is expected to generate results before the end of the year.
AZD7442 is a combination of antibodies derived from convalescent plasma, taken from patients who have been infected with SARS-CoV-2 but have recovered.
The two antibodies were discovered by Vanderbilt University Medical Center and licensed to AZ in June. In animal and human cell models, the cocktail has been shown to block the binding of the SARS-CoV-2 virus to host cells and protect against infection.
The rationale behind the drug is the same as Regeneron’s REGN-COV2 antibody cocktail, which is further ahead in development having started phase 3 testing in early July, with preliminary data expected in the coming weeks.
REGN-COV2 advanced into phase 2/3 on the strength of a single phase 1 study, and the US government has already agreed a deal to scale up manufacturing and claim the first doses to be made.
Regeneron’s drug is being tested as a single intravenous dose in the treatment of established COVID-19, and as a subcutaneous dose in prevention studies involving household contacts of people infected with the coronavirus. A recently-started trial of the antibody is looking at a dosing frequency for subcutaneous injections of every four weeks.
Mene Pangalos, head of biopharmaceuticals R&D at AZ, says that AZD7442 has been developed using a half-life extension technology that “has the potential to improve both the effectiveness and durability of use in addition to reducing the likelihood of viral resistance.”
The half-life extended antibodies should afford at least six months of protection from COVID-19, according to AZ. If that profile is backed up in clinical testing it could mean that supplies of AZD7442 – which could be limited initially – will stretch further.
The FDA has just granted emergency use authorisation to the use of convalescent plasma to treat severe COVID-19 cases in the US – notably despite reservations among some health experts.
However, there are advantages to having off-the-shelf, standardised antibodies such as REGN-COV2 and AZD7442 that have been tested clinically and may reduce the risk of side effects.
Another approach that avoids the use of plasma itself was proposed by a group of companies that specialise in plasma-derived drugs back in April.
Led by Takeda and CSL Behring, the consortium – which also includes Biotest, BPL Group, LFB and Octapharma – is working on an “unbranded” hyperimmune immunoglobulin drug for SARS-CoV-2.
The post Chasing Regeneron, AZ starts trials of its COVID-19 antibody cocktail appeared first on .
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Click here to read full press release/ article | Ref: AstraZeneca | Image: Outsourcing Pharma
Volunteers are receiving doses of drug, which has potential both as a vaccine and a treatment
The pharmaceutical group AstraZeneca has started a clinical trial of a drug to help prevent and treat Covid-19, with the first volunteers already receiving doses.
The company, which is separately developing a potential Covid-19 vaccine together with scientists at Oxford University, said the drug, known as AZD7442, is a combination of two monoclonal antibodies.
AstraZeneca says it has not discussed ‘emergency use authorisation’ with the US
The company manufacturing the Oxford University coronavirus vaccine has denied it is in talks with the Trump administration about fast-tracking its vaccine for emergency use ahead of November’s presidential elections.
With both Russia and China pressing ahead with inoculations involving experimental vaccines yet to pass final efficacy and safety trials, the Trump administration has become increasingly frustrated with the Food and Drug Administration (FDA), which the president has tried to suggest is slowing approval of a vaccine for “political reasons”.
Related: Covid vaccine tracker: when will we have a coronavirus vaccine?
Shots:
Click here to read full press release/ article | Ref: PRNewswire | Image: Renalytixa
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
Published: Aug 20, 2020 | Tags: US, FDA, Approves, Kyprolis, carfilzomib, Darzalex, (daratumumab), Dexamethasone, Two Dosing, Regimens, RRMM
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
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
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
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
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
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
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
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
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
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Click here to read full press release/ article | Ref: AstraZeneca | Image: Clinical Lab Products
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Click here to read full press release/ article | Ref: AstraZeneca | Image: Fierce Pharma
The FDA is to review data supporting AstraZeneca’s Imfinzi (durvalumab) cancer immunotherapy in a new four-week regimen that will halve the number of required clinic visits for patients with lung and bladder cancer.
The regulator has granted a faster six-month Priority Review for the fixed dose regimen, based on data from several Imfinzi clinical trials, including results from the phase III CASPIAN trial in extensive stage small-cell lung cancer (ES-SCLC) which used the four-week, fixed-dose regimen during maintenance.
AZ hopes that the new dosing regimen will be able to offer patients and doctors an alternative to the existing fortnightly regimen, allowing the drug to gain traction and taking pressure off clinics during the COVID-19 pandemic.
The strategy is similar to one employed by Merck & Co, which has extended the length of the dosing regimen for its rival immunotherapy Keytruda from three to six weeks in certain indications.
The FDA grants Priority Review to applications for medicines that offer significant advances over available options for serious diseases in terms of safety, efficacy preventing serious conditions, or patient compliance.
Cutting the number of visits to clinics is an important factor in getting patients to comply with regimens, saving on travel costs and reducing the impact on patients’ lives.
A regulatory decision is due during the fourth quarter of 2020.
Dave Fredrickson, executive vice president at AstraZeneca’s oncology unit, said: “The new less-frequent dosing option for non-small cell lung cancer and bladder cancer will simplify and improve treatment by enabling continuity of care while minimising the risk of exposure to infection in the healthcare setting.
“This takes on particular urgency during the current pandemic, as doctors care for patients at high risk of COVID-19 complications.”
Imfinzi is approved in the curative-intent setting of unresectable, stage III NSCLC after chemoradiation therapy in the US, Japan, China, across the EU and in many other countries, based on the phase 3 PACIFIC trial.
Imfinzi is also approved for previously treated patients with advanced bladder cancer in the US and several other countries.
It is also approved in the US and under review in Japan and other countries for ES-SCLC. Imfinzi was also recently recommended for marketing authorisation in the EU for this indication.
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Click here to read full press release/ article | Ref: mAbxience | Image: Thailand Medical News
Related News: AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021
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.
ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing.
The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.
The order comes after the Commission put agreements in place for the supply of two other vaccines – from Johnson & Johnson and Sanofi/GlaxoSmithKline – that will be activated if the shots prove their worth in clinical trials.
Those deals cover 200 million doses of J&J’s Ad26.COV2.S – with an option on another 200 million – and 300 million doses of the Sanofi/GSK candidate. Meanwhile, the EC is also talking to Pfizer/BioNTech, Moderna and CureVac about access to their COVID-19 shots.
There are concerns that the scale of the deals – which comes after a series of similar big orders from the US and other national governments – could make accessing supplies more difficult for organisations such the WHO and GAVI, which are aiming to supply less affluent countries.
Reuters says that the Commission has “urged EU states to shun the WHO-led initiative because it sees it as too expensive and slow.”
The EU is now suggesting that it could use a portion of its vaccine orders to supply countries elsewhere in the world, which could be viewed as stepping on the toes of these non-governmental organisation (NGO) initiatives.
“We will continue to work tirelessly to bring more candidates into a broad EU vaccines portfolio,” said Stella Kyriakides, EU Commissioner for Health and Food Safety, adding that a vaccine “remains the surest exit strategy to protect our citizens and the rest of the world from the coronavirus.”
The advance order will be financed using the EU’s Emergency Support Instrument, a €2 billion fund set aside to cover purchases of vaccines, drugs and other goods needed to fight the coronavirus epidemic.
The fund has already been deployed to order Gilead’s antiviral drug Veklury (remdesivir) and apheresis equipment to collect antibodies from the blood of patients who have recovered from COVID-19.
Last month, interim results from a phase 1/2 trial of ChAdOx1 were published in The Lancet and showed the jab was tolerated and generated immune responses against the SARS-CoV-2 virus in all vaccinated participants.
It is based on an adenoviral vector formed on a weakened version of the adenovirus that causes a common cold-line illness in chimpanzees, containing the genetic material of SARS-CoV-2 spike protein.
AZ said that it has now signed supply deals for around 3 billion doses of the vaccine, with Russia, South Korea, Japan, China, Latin America and Brazil also placing orders.
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