Pfizer and BioNTech to submit Emergency Use Authorization request today to the U.S. FDA for COVID-19 vaccine
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.
Pfizer and BioNTech conclude Phase 3 study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study's primary efficacy endpoints.
Moderna's COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study
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- Category: Business
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.
Swissmedic begins rolling review of Moderna's mRNA vaccine against COVID-19 (mRNA-1273)
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- Category: Business
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that Swissmedic has started a rolling review of mRNA-1273, the Company's vaccine candidate against COVID-19.
Lilly's neutralizing antibody bamlanivimab (LY-CoV555) receives FDA emergency use authorization for the treatment of recently diagnosed COVID-19
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- Category: Eli Lilly and Company
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for Eli Lilly and Company's (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Medicago and GSK announce start of Phase 2/3 clinical trials of adjuvanted COVID-19 vaccine candidate
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- Category: GlaxoSmithKline
Medicago, a biopharmaceutical company headquartered in Quebec City, and GSK have announced the start of Phase 2/3 clinical trials of its plant-derived vaccine candidate for COVID-19 to evaluate its efficacy, safety, and immunogenicity. Based on the positive Phase 1 results, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant.
The Sputnik V COVID-19 vaccine efficacy amounted to 92% in Phase III clinical trials
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The National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya of the Ministry of Health of the Russian Federation (Gamaleya Center) and the Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund), announce that the Sputnik V vaccine, the world's first registered vaccine against coronavirus (registered on the 11 th of August under the emergency use authorization mechanism) created on the well-studied platform of human adenoviral vectors, demonstrated high efficacy.
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- Sanofi offers to acquire Kiadis for €308 million
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- Data for Lilly's bamlanivimab (LY-CoV555) in COVID-19 outpatients published in New England Journal of Medicine
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