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The FDA is revisiting its stance on compounded peptides with plans for advisory panel meetings. Also, a sweeping Cochrane review is fueling fresh debate over amyloid-targeting Alzheimer’s drugs. And more.
The need-to-know this morning
- Roche said it will run another trial of Elevidys, the Duchenne muscular dystrophy gene therapy developed by Sarepta Therapeutics, in an attempt to win European approval. Sarepta markets the drug in the U.S., while Roche has rights to the therapy outside the U.S.
- Eli Lilly said its GLP-1 pill Foundayo showed non-inferiority compared with insulin glargine in a cardiovascular outcomes trial of people with diabetes and obesity. The company said it will submit Foundayo to the FDA as a treatment for type 2 diabetes by the end of the second quarter under the Commissioner’s National Priority Review Voucher.
FDA reopens door to compounded peptides
The Food and Drug Administration is calling for an outside advisory panel to reconsider whether compounding pharmacies should be allowed to make a spate of controversial peptides it previously moved to restrict. The first meetings will be in July, and a later one will be held before February 2027, STAT’s Lizzy Lawrence and Sarah Todd write.
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