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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- Category: Business
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.
Novavax COVID-19 vaccine granted Fast Track Designation by U.S. FDA
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- Category: Business
Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM™ adjuvant.
More Pharma News ...
- Pfizer and BioNTech announce vaccine candidate against COVID-19 achieved success in first interim analysis from Phase 3 study
- Novartis provides update on CAN-COVID trial in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS)
- Sanofi offers to acquire Kiadis for €308 million
- Novavax and Commonwealth of Australia announce agreement in principle for acquisition of Novavax COVID-19 vaccine
- Data for Lilly's bamlanivimab (LY-CoV555) in COVID-19 outpatients published in New England Journal of Medicine
- Novartis announces collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19
- Novavax announces facility expansion to support global vaccine development