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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
The FDA is establishing an information-sharing network so states can provide information about compounding pharmacies to the agency — and to share notes among themselves. Read More
The FDA is proposing to add quinacrine hydrochloride to its 503B bulk substances list that outsourcing facilities may use in drug compounding. Read More