Pfizer and BioNTech receive U.S. FDA Emergency Use Authorization of COVID-19 vaccine booster for individuals 12 years of age and older
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 years of age and older. The booster dose is the same dosage strength (30-µg) as the dose approved in the primary series.
AstraZeneca and Ionis close agreement to develop and commercialise eplontersen
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- Category: AstraZeneca
AstraZeneca has closed a global development and commercialisation agreement with Ionis Pharmaceuticals, Inc. (Ionis) for eplontersen, formerly known as IONIS-TTR-LRX.
The companies will jointly develop and commercialise eplontersen in the US, while AstraZeneca will develop and commercialise it in the rest of the world, except in Latin America.
Vaxzevria significantly boosted antibody levels against Omicron
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- Category: AstraZeneca
AstraZeneca's Vaxzevria (ChAdOx1-S [Recombinant]) significantly boosted levels of antibodies against the Omicron SARS-CoV-2 variant (B.1.1.529) following a third dose booster, according to data from a new laboratory study.(1)
Neutralisation titres for Omicron were boosted following a third dose with Vaxzevria compared to titres after a second dose.(1)
European Commission grants conditional marketing authorization for Novavax COVID-19 vaccine
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- Category: Business
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the European Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
Evusheld long-acting antibody combination retains neutralising activity against Omicron variant in independent FDA study
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- Category: AstraZeneca
AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination for the prevention of COVID-19, retained neutralising activity against the Omicron SARS-CoV-2 variant (B.1.1.529), according to new preclinical data.
In this study, Evusheld's Inhibitory Concentration 50 (IC50), a measure of neutralising potency of an antibody, was 171 ng/ml and 277 ng/ml in two confirmatory tests, which is within the range of neutralising titres found in someone who has been previously infected with COVID-19.
Novartis announces T-Charge™, next-generation CAR-T platform with first-in-human data at ASH 2021
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- Category: Novartis
Novartis announced the introduction of T-Charge™, the company's next-generation CAR-T platform that will serve as the foundation for various new investigational CAR-T cell therapies in the Novartis pipeline. At the 63rd American Society of Hematology Annual Meeting & Exposition (ASH) 2021, Novartis will present early clinical data from ongoing Phase I clinical trials with YTB323 (anti-CD19) and PHE885 (anti-BCMA),
Medicago and GSK announce positive Phase 3 efficacy and safety results for adjuvanted plant-based COVID-19 vaccine candidate
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- Category: GlaxoSmithKline
Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline plc (GSK) announce positive efficacy and safety results from the global Phase 3 placebo-controlled efficacy study of Medicago's plant-based COVID-19 vaccine candidate in combination with GSK's pandemic adjuvant, conducted in over 24,000 subjects (adults 18 years and above) across six countries.
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