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23 December, 2025 |
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Happy holidays! We won’t be sending newsletters starting tomorrow. We’ll be back in your inbox on Jan. 2! |
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Alexis Kramer |
Editor, Endpoints News
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by Max Bayer
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Companies that have voluntarily agreed to drug pricing deals with the White House appear to be exempt from two new CMS demonstration programs that have drawn consternation from pharma industry groups. A Jefferies analyst note published Monday said that five drugmakers with “most favored nation” deals with the government — Lilly,
Novartis, Merck, Gilead and Bristol Myers Squibb — told the bank they're exempt from the proposed Medicare pricing demos released last week. Endpoints News reached out to all 14 companies that have voluntarily agreed to drug pricing deals with the White House and heard back from half by the time of publishing. A spokesperson for Merck confirmed the note was accurate, while representatives for Gilead and Roche-owned Genentech said they won't be subject to future pricing mandates. A spokesperson said GSK expects to be exempted from the proposed demos. Novo Nordisk, Sanofi and Eli Lilly declined to
comment. | |
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by Elizabeth Cairns
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A patient in Pfizer’s trial of its hemophilia drug Hympavzi died from a thrombotic stroke, the drugmaker said Monday. Pfizer said it had informed regulators and investigators of the death. In a statement emailed to Endpoints News, it said that it didn’t “anticipate any impact to safety” for patients given
Hympavzi. Pfizer said the patient died after experiencing a stroke originating in the arteries that provide blood to the brain and spine, followed by cerebral hemorrhage. According to a statement from the European Haemophilia Consortium, the person died on Dec. 14. The consortium is a European patient group for people with bleeding disorders. While it
didn’t say how it knew the added information, patient and physician groups often receive information from drugmakers when there is a safety issue in a trial. | |
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by Elizabeth Cairns
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Novo Nordisk has won US approval of the first oral treatment for obesity in more than a decade. The Danish drugmaker’s obesity pill was approved by the FDA on Monday. It is an oral form of Novo’s blockbuster weight loss
shot Wegovy, and could allow Novo to reach a new population of patients who prefer not to take injections. Novo has already reached a deal with the US government, which will see the starter dose go on sale at $150 per month. Weight loss pills have a long and ignoble history, from dangerous products like amphetamines in the 60s and fen-phen in the 90s to much safer, though not hugely effective, pills like Vivus’s Qsymia and Orexigen’s (later Nalpropion's) Contrave in the 2010s. | |
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by Ayisha Sharma
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Neurocrine Biosciences’ Ingrezza has failed a late-stage trial in a type of cerebral palsy, adding to a spate of clinical disappointments for the biotech in recent years. Neurocrine did not immediately respond to an Endpoints News query about whether it would continue to develop the drug or not. Ingrezza missed the primary and key secondary endpoints in a placebo-controlled Phase 3 study called KINECT-DCP, according to a Monday release. The trial’s primary endpoint looked at Ingrezza’s ability to reduce a type of involuntary movement called chorea. KINECT-DCP enrolled 86 children and adults with dyskinetic cerebral palsy (DCP) who have choreiform movements. Neurocrine did not share detailed results, but said it will do so at a future medical meeting. | |
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John Carroll
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Editor & Founder
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Arsalan Arif
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Publisher & Founder
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Igor Yavych
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Architect & Founder
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Valentin Manov
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Creative Director
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