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The FDA has not wavered on its October 2020 call for AMAG Pharmaceuticals to withdraw its preterm birth progestin drug Makena and generic versions of it even after a meta-analysis from multiple trials found that it reduced preterm birth before 34 weeks. Read More
Novartis’ Kesimpta and Roche’s Evrysdi both received marketing authorizations from the European Commission (EC) Tuesday, setting the stage for new competing indications between the two companies. Read More
Merck has hit another snag as it seeks a new breast cancer indication for its blockbuster oncology drug Keytruda — a Complete Response Letter (CRL) from the FDA seeking more supporting evidence for its supplemental Biologics License Application (sBLA). Read More
Humanigen said it will seek an FDA Emergency Use Authorization for its monoclonal antibody lenzilumab “as soon as possible” based on positive results from a phase 3 clinical trial that showed the drug significantly reduced the risk of death for hospitalized COVID-19 patients. Read More
The Pfizer/BioNTech and Moderna vaccines are highly effective at preventing SARS-CoV-2 infections among healthcare and essential workers, a real-world study by the Centers for Disease Control and Prevention (CDC) has confirmed. Read More
Novavax has enlisted GlaxoSmithKline (GSK) to help it mass produce its promising COVID-19 vaccine in the UK as the inoculation draws closer to potential authorization. Read More
Eli Lilly’s bamlanivimab with Vir Biotechnology’s and GlaxoSmithKline’s VIR-7831 appear to be a potent antibody combination against COVID-19 infection, significantly reducing viral load in a mid-stage study. Read More
A group of House Democrats has called on the Federal Trade Commission (FTC) to begin an investigation into potential collusion between insulin makers Eli Lilly, Novo Nordisk and Sanofi to significantly raise the price of the lifesaving drug. Read More