Pfizer Inc. has delivered on its threat of legal action against the attempt by Novo Nordisk A/S to scupper its acquisition of Metsera Inc., and has filed two lawsuits, one alleging breach of contract, and a second claiming that a merger of Novo Nordisk and Metsera would violate antitrust regulations.
Uniqure NV is regrouping after a surprise switcheroo by the havoc-beset U.S. FDA regarding phase I/II studies with AMT-130 vs. external control in Huntington’s disease (HD) – news of which pushed down the Lexington, Mass.-based firm’s shares (NASDAQ:QURE) Nov. 3 by $33.40, a loss of 49%, at the closing price of $34.29.
The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George Tidmarsh, a biopharma industry veteran who’s helmed CDER for a little more than three months, resigned effective immediately Nov. 2 after being placed on administrative leave two days earlier amid a Department of Health and Human Services probe.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Amnea, Celltrion, Dewpoint, Intellia.
Biopharma happenings, including deals and partnerships, and other news in brief: 89bio, Anavex, Everest Medicines, Insmed, Novabridge, Roche, Sensei, Visara.
Clinical updates, including data readouts and publications: Argenx, Avobis, Dianthus, Innocare, Johnson & Johnson, Neutrolis, Novartis, Tectonic, Unicycive, Vor, Wave.
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