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

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

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

Vaccine developers look to be meeting their vaccine supply commitments for March, a senior White House official confirmed yesterday. Read More

The U.S. government will send out 11 million doses of Johnson & Johnson’s (J&J) one-shot vaccine this week, according to a White House official, marking a rise in vaccine production after a slow start. 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

Just four months after Eli Lilly’s COVID-19 antibody therapy, bamlanivimab, received FDA Emergency Use Authorization (EUA), HHS is restricting nationwide distribution of it due to concerns about an increase in variants of SARS-CoV-2 that are resistant to the drug. Read More

A new UK study shows that one dose of the Pfizer-BioNtech COVID-19 vaccine offers as much immunity to the virus as having previously had a COVID infection. Read More