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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
GlaxoSmithKline (GSK) and Vir Biotechnology have filed for Emergency Use Authorization (EUA) for their SARS-CoV-2 monoclonal antibody ahead of schedule, having recently stopped their phase 3 trial after seeing significantly positive results. Read More
The Pfizer/BioNTech COVID-19 vaccine is seeing progress on multiple fronts, including a newly launched study in children as young as six months old, a billion-dose a year manufacturing facility that will come on stream in Germany next month and less onerous storage temperatures expected soon in the EU. Read More
A group of academics, policy experts and nonprofits has penned a letter to HHS and the National Institutes of Health (NIH) urging the government to draw up provisions that improve global access to Moderna’s COVID-19 vaccine as part of any patent-licensing agreement for the drugmaker. 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
Novartis is free to pay for low-income patients to receive its pricey CAR-T therapy Kymriah (tisagenlecleucel), and those payments will not be considered illegal. 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
As Novavax gears up to file for authorizations for its two-dose COVID-19 vaccine, the U.S. drugmaker has been working to significantly expand its manufacturing capabilities in Europe and other parts of the globe and believes it can supply well over 100 million doses a month by the fall. Read More