Now that the FDA has granted emergency use authorization to Eli Lilly and Co.’s bamlanivimab, the company plans to manufacture up to 1 million doses of the therapy by year-end with worldwide distribution to mild to moderate COVID-19 patients ages 12 and older in early 2021.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Betterlife, Clinigen, Emmaus, Forma, Immune-Onc, Lilly, Oryzon, Praxis, Rafael, Supernus.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amo, Astrazeneca, Axovant, Bayer, Beigene, Eusa, Impel, Liminal, Novavax, Orphazyme, Sorrento.
The latest global regulatory news, changes and updates affecting biopharma, including: Final analysis: hydroxychloroquine offers no benefit; FDA finalizes PDUFA VI fee guidance.
Talk turned skeptical well before lunchtime in the meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee to consider Biogen Inc.’s aducanumab for Alzheimer’s disease, and it stayed that way until the end, when panelists voted thumbs down.
LONDON – After a year in the mill, the U.K. National Institute for Health and Care Excellence (NICE) has put proposals for how it intends to evaluate drugs, devices and diagnostics in the future out for consultation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Astellas, Basilea, Gosun, Bristol Myers Squibb, Lipocine, Sarepta, Sedor, Senhwa.
The U.S. Court of Appeals for the Federal Circuit narrowed the landscape for filing Hatch-Waxman infringement suits against U.S.-based companies, as it answered yet another question raised by the Supreme Court’s unanimous decision in TC Heartland v. Kraft Foods, which dramatically changed venue parameters in 2017 for all patent infringement cases.
Shares of Bluebird Bio Inc. (NASDAQ:BLUE) sank 16.6%, or $9.72, to close at $48.83 as Wall Street reacted to news that the U.S. regulatory filing for Lentiglobin in sickle cell disease (SCD) will be delayed. Previously expected in the second half of next year, the filing won’t happen until late 2022.
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