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The EU expects to see a significant increase in deliveries in the second quarter, allowing it to meet its goal of vaccinating 70 percent or more of its population by July. 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
As part of postmarket surveillance, devicemakers should continuously monitor the performance of their devices, including for new potentially cross-reacting agents that could lead to inaccurate results, the group said. 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
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