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5 March, 2026 |
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Three drugs have now been approved under the FDA’s controversial voucher program that’s meant to significantly speed reviews. The latest approval, for Johnson & Johnson’s multiple myeloma combo treatment, came 55 days after J&J filed its application. To date, one voucher recipient (Disc Medicine) has been rejected. |
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Alexis Kramer |
Editor, Endpoints News
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by Max Bayer
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A new bonus pilot program meant to reward fast-working FDA reviewers will be funded in part by money from industry user fees, the first details on how Commissioner Marty Makary plans to finance the incentive, sources and government spokespeople told Endpoints News. Getting drug applications reviewed on time is one of the FDA’s most
closely-watched metrics. Sources familiar with the incentive program, speaking on the condition of anonymity, said that the money from user fees is available because of existing staffing shortages at the FDA after job cuts last year. Drug developers pay annual and application-related fees to the agency, which help pay for staff that review those products. | |
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Adam Steensberg, Zealand Pharma CEO (Betty Laura Zapata/Bloomberg via Getty Images) |
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by Kyle LaHucik
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Zealand Pharma is out with the Phase 2 data for an amylin analog that spurred one of the industry’s largest-ever obesity drug deals last year. The drug, called petrelintide, led to up to 10.7% mean body weight loss at week 42 as compared to 1.7% for placebo in a Phase 2 study dubbed ZUPREME-1, Zealand said Thursday afternoon. The trial included 493 people with obesity or overweight at a mean BMI of 37 kg/m². Petrelintide is one of the most watched next-generation obesity drug candidates in development. It’s the focal point of a $1.65 billion upfront deal — and up to $5.3
billion in biobucks — with Roche for co-development and co-commercialization. | |
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by Lei Lei Wu
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Mid-stage data from Helus Pharma’s psychedelic drug raised questions about the doses the company picked for treating anxiety. Two doses — one 10 times higher than the other — led to virtually the same efficacy results. On Thursday, Helus said the Phase 2 data showed its experimental psychedelic treatment led to a “clinically meaningful improvement” in symptoms of generalized anxiety disorder compared to baseline. But there was little difference in efficacy between the two doses being tested, an indication that a treatment may not be working well or that the selected doses may not be right. Helus’ shares HELP fell 37% Thursday morning following the data
release. | |
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