How controversial was the FDA’s decision to approve Sarepta’s gene therapy? Check its footnotes

Taking stock of the drug industry, from the lab to the medicine chest

July 2, 2024 Check out STAT+

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By Ed Silverman Pharmalot Columnist, Senior Writer

Anna Moneymaker-Pool/Getty Images STAT+ | How controversial was the decision by FDA's Peter Marks to approve Sarepta's gene therapy? Check its footnotes Marks' unilateral decision to overrule three different review teams and approve the Duchenne therapy looks even more surprising on a close examination. By Matthew Herper STAT+ | FDA approves Eli Lilly's early Alzheimer's treatment The treatment, donanemab, which will be sold under the brand name Kisunla, was shown to modestly slow the cognitive decline associated with the disease. By Elaine Chen and Matthew Herper STAT+ | Report shows U.S. biotechs are wary of Chinese partnerships due to looming BIOSECURE Act A survey by China-based L.E.K. Consulting found a looming anti-China biotechnology bill has spooked U.S. life sciences companies. By John Wilkerson Ruby Wallau for STAT Moderna receives $176 million from BARDA for mRNA influenza vaccines The Cambridge, Mass. company said Tuesday it will receive $176 million from HHS' BARDA to accelerate development of mRNA-based pandemic influenza vaccines. By Helen Branswell Opinion: The rare pediatric disease voucher program creates new treatments. I have new data to prove it A few naysayers in Congress dispute the effectiveness of the rare pediatric disease voucher program. NORD has data showing it works. By Pamela K. Gavin Opinion: Senate, FTC cracking down on pharma patent shenanigans In this First Opinion essay, FTC Chair Lina Khan and U.S. Sen. Dick Durbin urge action on drug company patent abuse as a way to lower high drug costs. By Dick Durbin and Lina M. Khan

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