European Commission grants conditional marketing authorization for Novavax COVID-19 vaccine
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.
Read more ...
Pfizer and BioNTech receive expanded U.S. FDA emergency use suthorization of COVID-19 vaccine booster to include individuals 18 and older
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 18 years of age and older. The booster dose is to be administered at least six months after completion of the primary series, and is the same dosage strength as the doses in the primary series.
Read more ...
Petrovax Pharm is taking part in the international pharmaceutical exhibition CPhI Worldwide-2021
Petrovax Pharm, the Russian biopharmaceutical company, will participate in CPhI Worldwide-2021 - the international specialized pharmaceutical industry exhibition. This year, it will be held from 9 to 11 November in Italy (Milan) on the territory of the largest exhibition complex Fiera Milano.
Read more ...
Pfizer and BioNTech receive CHMP positive opinion for COVID-19 vaccine booster in the European Union
Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies' COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older.
Read more ...
University of Oxford and Oracle Cloud System helping researchers identify COVID-19 variants faster
The fast spread of the highly infectious Delta variant underscores the need for faster identification of COVID-19 mutations. Uniting governments and medical communities in this challenge, the University of Oxford and Oracle's Global Pathogen Analysis System (GPAS) is now being used by organizations on nearly every continent.
Read more ...
Pfizer and BioNTech submit a variation to EMA with the data in support of a booster dose of COMIRNATY®
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) with data supporting a booster (third) dose of COMIRNATY® (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older.
Read more ...
U.S. FDA grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 vaccine
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.
Read more ...
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. 
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 18 years of age and older. The booster dose is to be administered at least six months after completion of the primary series, and is the same dosage strength as the doses in the primary series. 
Petrovax Pharm, the Russian biopharmaceutical company, will participate in CPhI Worldwide-2021 - the international specialized pharmaceutical industry exhibition. This year, it will be held from 9 to 11 November in Italy (Milan) on the territory of the largest exhibition complex Fiera Milano.