Pfizer and BioNTech to supply the U.S. with 100 million additional doses of COVID-19 vaccine
- Details
- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a second agreement with the U.S. government to supply an additional 100 million doses of the companies' COVID-19 Vaccine from production facilities in the U.S. This agreement brings the total number of doses to be delivered to the U.S. to 200 million.
Pfizer and BioNTech receive authorization in the European Union for COVID-19 vaccine
- Details
- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the European Commission (EC) has granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for COMIRNATY® (also known as BNT162b2), for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.
Pfizer and BioNTech receive CHMP positive opinion for their COVID-19 vaccine
- Details
- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the conditional marketing authorization (CMA) of the Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2), for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.
Vir Biotechnology and GSK announce start of NIH-sponsored ACTIV-3 trial evaluating VIR-7831 in hospitalised adults with COVID-19
- Details
- Category: GlaxoSmithKline
Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the first patient has been dosed in a new sub-trial of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial.
Valneva initiates Phase 1/2 clinical study of inactivated, adjuvanted COVID-19 vaccine candidate
- Details
- Category: Business
Valneva SE, a specialty vaccine company focused on prevention against diseases with major unmet needs, today announced the initiation of a Phase 1/2 clinical study for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
VLA2001 leverages the manufacturing platform of Valneva's licensed Japanese encephalitis vaccine, IXIARO® and is the first publicly announced inactivated vaccine against COVID-19 to commence clinical development in Europe.
Pfizer and BioNTech celebrate historic first authorization in the U.S. of vaccine to prevent COVID-19
- Details
- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. The vaccine is now authorized under an Emergency Use Authorization (EUA) while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.
Novartis provides update on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19
- Details
- Category: Novartis
Novartis today announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint(1). Initial data show there was no statistically significant reduction in the proportion of patients on ruxolitinib plus SoC therapy who experienced severe complications, including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) by Day 29, compared to SoC alone(1).
More Pharma News ...
- Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine programme to improve immune response in the elderly
- Pfizer and BioNTech receive FDA Advisory Committee vote supporting potential first Emergency Use Authorization for vaccine to combat COVID-19 in the U.S.
- Pfizer and BioNTech announce publication of results from landmark Phase 3 trial of BNT162b2 COVID-19 vaccine candidate in The New England Journal of Medicine
- Moderna announces first participants dosed in Phase 2/3 study of COVID-19 vaccine candidate in adolescents
- Pfizer and BioNTech achieve Health Canada authorization for their vaccine to combat COVID-19
- AZD1222 Oxford Phase III trials interim analysis results published in The Lancet
- Lilly announces 650,000 additional doses of neutralizing antibody bamlanivimab (LY-CoV555) purchased by U.S. government to treat COVID-19