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17 December, 2025 |
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GSK told us today that it has formally applied to update its label for leucovorin, per the FDA’s request. The agency asked GSK in September to add a new indication for cerebral folate deficiency, a developmental disorder that’s been linked to autism. But it still isn’t clear what data the FDA was relying on. The request has also raised several other questions, including who will
supply the drug. |
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Alexis Kramer |
Editor, Endpoints News
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by Drew Armstrong, Max Bayer
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The White House is preparing to unveil several new deals with large drugmakers on Friday as part of the administration’s “most favored nation” pricing push, according to sources familiar with the plans. The announcement is likely to mimic other recent most favored nation unveilings, with company CEOs and President Donald
Trump in the Oval Office, said the sources, all of whom spoke on condition of anonymity because the announcement isn’t yet public. The administration has been working to finalize the deals, under which drugmakers have agreed to cash-pay prices for some drugs, and to give the government discounts on others in Medicare or Medicaid. So far, Pfizer, AstraZeneca, Eli Lilly, Novo Nordisk and EMD Serono have made deals. | |
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by Jared Whitlock
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The Biosecure Act is slated to become law after the Senate on Wednesday passed a defense bill that includes the measure. It's a development that once would have sent panic through drugmaker boardrooms. But the legislation has since been weakened. Biosecure would restrict federal contracts with biopharma suppliers deemed foreign adversaries,
though unlike earlier drafts, it stops short of naming the ubiquitous contractors WuXi AppTec and WuXi Biologics. Sens. Bill Hagerty (R-TN) and Gary Peters (D-MI) revived the legislation this summer following influential opposition. Last year, Rep. Jim McGovern (D-MA) and Sen. Rand Paul (R-KY) killed Biosecure by arguing it lacks due process for the WuXi entities. That led to a compromise version that no longer names specific companies. Instead, the latest iteration imposes restrictions on companies that are on federal watchlists. The Senate voted in October to attach this new version to the annual defense policy bill. | |
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A nurse puts a blood sample from a newborn onto a file card for a rare disease screening (Arno Burgi/picture-alliance/dpa/AP Images) |
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by Jared Whitlock
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HHS Secretary Robert F. Kennedy Jr. added two conditions to a federal newborn screening list, reviving efforts that had been stalled under the Trump administration — though the process for adding more diseases is still uncertain. During an HHS event on Tuesday, Kennedy said metachromatic leukodystrophy (MLD) and Duchenne muscular dystrophy
will be placed on the federal government’s Recommended Uniform Screening Panel. Drugmakers and patient advocates welcomed the decision, after warning that delays could imperil access to critical therapies. In April, an executive order signed by President Donald Trump to eliminate “unnecessary” federal functions shut down the Advisory
Committee on Heritable Disorders in Newborns and Children. The committee recommends diseases to screen for at birth, though states typically adopt the recommendations wholesale over time. | |
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Emma Walmsley, GSK CEO (courtesy Financial Times) |
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