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Novo’s CagriSema Disappoints in Pivotal Trial

The highly anticipated results of Novo’s CagriSema have been released, showing disappointing outcomes in its pivotal trial. Meanwhile, Ionis gains FDA approval for a new drug, and the FDA announces that tirzepatide is no longer in shortage.

The long-awaited results of Novo’s CagriSema have been disclosed, revealing disappointing outcomes in its pivotal trial. This development comes as Ionis Pharmaceuticals secures FDA approval for a new drug, marking a significant step towards bringing its commercialization efforts in-house. Additionally, the FDA has declared that tirzepatide, a medication previously in short supply, is now adequately available.
In other news, Applied Therapeutics has announced the resignation of its embattled CEO, Shoshana Shendelman, with current CFO Les Funtleyder stepping in as interim CEO. The company has also withdrawn its European marketing application for the rare-disease drug govorestat, following the FDA's rejection of the drug earlier this month.
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Reference News

[1]
Is a contrarian leader good for the FDA?
statnews.com · Dec 20, 2024

CagriSema trial results disappoint; Ionis gains drug approval, plans in-house commercialization; FDA resolves tirzepatid...

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