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19 December, 2025 |
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Bristol Myers Squibb and Johnson & Johnson are expected to ask the Supreme Court today to take up their cases against Medicare drug price negotiations. AstraZeneca was the first drugmaker (and so far the only) to petition the high court to hear its IRA case, and several other companies have filing deadlines after the new year. |
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Alexis Kramer |
Editor, Endpoints News
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President Donald Trump (Evan Vucci/AP Images) |
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by Zachary Brennan
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The White House on Friday announced new deals with nine major drugmakers, finalizing an end-of-year push by President Donald Trump to make good on his “most favored nation” pledge for lower medicine prices. Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Genentech, GSK, Gilead, Merck, Novartis and Sanofi agreed to sell select medicines at
lowered prices along the lines of some European and other comparable countries. A senior administration official predicted major reductions in Medicaid prices as a result of the latest deals. They said that many of the current Medicaid prices for drugs from companies in Friday's deals are much higher than what other, comparable countries are paying. | |
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by Alex Hoffman, Kyle LaHucik
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This is our final Peer Review in 2025. Thank you for reading the latest comings and goings for another year. Enjoy the holidays, and we’ll see you again on Jan. 9! → Kathy Fernando has left Pfizer for Replicate Bioscience, a small self-replicating RNA startup in the Apple Tree Partners web of companies. Fernando spent 11 years at Pfizer, eventually serving as SVP and global head of Pfizer Ignite, a development and clinical services program for biotech
partners. Now, she’ll be chief business officer at Replicate, which inked an obesity pact with Novo Nordisk in August and a rabies vaccine deal with a Brazilian nonprofit earlier this month. Rachael Lester left the CBO role at Replicate shortly after the Novo deal to become CBO at CytomX Therapeutics. Fernando was one of the first graduate students in Drew Weissman’s lab at UPenn. In a LinkedIn post on Tuesday, Fernando said she spent “several months” looking for her “next dream job.” She found it, she wrote, and she’ll be “going back to my mRNA roots.” | |
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Sens. Markwayne Mullin (R-OK) and Bernie Sanders (I-VT) (Michael Brochstein/Sipa USA/Sipa via AP Images; Francis Chung/Politico via AP Images) |
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by Zachary Brennan
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Sens. Bernie Sanders (I-VT) and Markwayne Mullin (R-OK) are not seeing eye to eye on why the Senate failed to pass legislation reauthorizing the FDA's rare pediatric priority review voucher program. Mullin took to the Senate floor on Wednesday to urge lawmakers to renew the program, with support from Sens. Bill Cassidy (R-LA) and Maggie Hassan (D-NH). The
transferable vouchers were created in 2012 to incentivize new drugs to treat rare pediatric illnesses, including rare cancers and genetic diseases. The vouchers could be used to speed approval of a future drug, and could also be sold. In recent years, they’ve been sold for more than $100 million each, but the program ended when Congress failed to reauthorize it in late 2024. | |
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by Anna Brown
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Prior to last month’s series of mass layoffs in Maryland, Catalent was issued two Form 483s for its gene therapy facil&s |
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