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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
The FDA has granted approval for Bristol Myers Squibb’s and bluebird bio’s personalized immune-cell therapy Abecma (idecabtagene vicleucel; ide-cel) for multiple myeloma in adults, marking the first chimeric antigen receptor (CAR) T-cell therapy for the plasma-cell cancer. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five medicines for approval at its monthly meeting last week — and issued a positive review of Celltrion’s monoclonal antibody, regdanvimab, for treatment of COVID-19. Read More