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6 February, 2026 |
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ICYMI, our Post-Hoc Live today was all about the showdown between Novo Nordisk and Hims & Hers. There are so many questions up in the air, like why now, and what’s Novo (or the FDA) going to do next. You can watch the recording on YouTube here. |
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Alexis Kramer |
Editor, Endpoints News
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by Max Bayer
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When President Donald Trump unveiled his anticipated direct-to-consumer drug platform on Thursday, he said he'd done what other politicians had promised but never delivered. "They all failed,” he said. “It was all words as usual." But the president's new site, TrumpRx, doesn't yet appear to match his promises. Only 43 drugs are available on TrumpRx, from about a third of the drugmakers that have agreed to participate in the program. In some cases, generic versions are available elsewhere, which are often cheaper. “It's mostly smoke and mirrors, designed to create the appearance of action when it'll actually help few people,” Ian Spatz, a
former public policy executive at Merck who's now a principal at Rock Creek Policy Group, told Endpoints News. | |
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by Nicole DeFeudis
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The Trump administration is taking a step back from its planned 340B rebate pilot that a court blocked last month. HHS asked a Maine federal court to set aside actions related to the original pilot program and send it back to the agency for review. The Thursday request marks the end of a hospital group's legal challenge and suggests that the agency will consider
creating a new version of the pilot. The aim of the original pilot was to shift the 340B drug pricing program from upfront discounts to a rebate model. In a joint motion filed Thursday, attorneys for HHS and the American Hospital Association wrote that if the agency decides to begin a new rebate program, it will issue a new notice, solicit new applications, and solicit comments
“either prior to or concurrently with a new notice, or both." | |
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by Zachary Brennan
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The FDA can continue to grant seven years of exclusivity for orphan drugs with new indications, as President Donald Trump this week signed a government funding extension that included a provision that codifies that process and runs counter to a 2021 appeals court decision against the agency. The alteration on orphan exclusivity
in the spending package, which the FDA had been lobbying Congress to fix since at least 2022, means the agency can still approve drugs for narrower uses or indications even if a competitor has an approved drug for the same disease. While the agency announced that it wouldn't change its orphan designation process in January 2023, the move ran counter to what the US Court of Appeals for the Eleventh Circuit told the FDA in 2021. The decision said the agency shouldn’t have approved two drugs for the same disease when one had exclusivity, even if the two were geared toward different patient populations. | |
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by Alex Hoffman, Kyle LaHucik, Kathy Wong
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Geoff McDonough is tipping his hat to one of the hottest targets in drug development right now. The former Generation Bio CEO has joined NodThera to get its NLRP3 program into Phase 3 next year as a bevy of drug developers shuttle their prospects
through the clinic. That includes Lilly-acquired Ventyx Biosciences, BioAge Labs, recent public entrant Insilico Medicine, Neumora and countless others. “I got really intrigued by the power of the mechanism, and it’s an orthogonal mechanism to the other things that we know are important in those diseases: insulin control, SGLT2s, GLP-1s, lipid-lowering agents,” McDonough said in an
interview with Endpoints News on his fourth day on the job. He joined NodThera’s board in December and, as of Feb. 2, he’s also CEO. He succeeded Daniel Swisher, who left in October after an 18-month stint at the UK and US
biotech. | |
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