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858 stories matching this filter · ← front page

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  • Updated: FDA adcomm backs popular wellness peptides, despite staff concerns
    An FDA advisory committee voted to recommend expanding access to popular peptides used by health and wellness enthusiasts for repairing muscles, healing injuries, boosting metabolism and reducing i…
    Endpoints · 5d ago↗ source
  • FDA to end pilot aimed at preventing production issues
    The FDA said it will end a pilot that was intended to help drugmakers proactively address production issues. Few companies took advantage of the program during its three-year run. In April 2027, th…
    Endpoints · 5d ago↗ source
  • Sartorius reduces revenue by €26M to refund Trump tariffs to customers
    Sartorius appears to be the first life science company to detail how tariff refunds are affecting its revenue, following the US Supreme Court decision to block some of President Donald Trump’s levi…
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Endpoints · 5d ago
↗ source
  • Lilly, with new data, to seek FDA approval of obesity drug retatrutide
    The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions about the additive benefits a “triple-G” drug has on heart health.
    BioPharma Dive · 5d ago↗ source
  • Merck CEO cautions Congress on imposing limits on Chinese dealmaking
    Merck CEO Rob Davis said he has warned Congress and the Trump administration that if they cut off or hamper US-China dealmaking, the US could lose its status as the world's biotech leader. China-li…
    Endpoints · 5d ago↗ source
  • Scancell plans Neuphoria merger; AstraZeneca wins EU nod for cancer drug
    Scancell to merge into Neuphoria: Scancell plans to take over Neuphoria Therapeutics' Nasdaq listing {$NEUP} and change the ticker to SCLT. The company eyes up to $89 million in equity and ...
    Endpoints · 5d ago↗ source
  • Biogen counts on drugs from Apellis deal to patch Leqembi's slow sales
    It’s no secret that sales of Leqembi have been disappointing. First approved in 2023, the Alzheimer’s drug from Eisai and Biogen launched shortly after Chris Viehbacher took the reins as Biogen CEO…
    Endpoints · 6d ago↗ source
  • What’s behind the proposed pullback on remote patient monitoring
    Companies that help doctors keep tabs on their patients at home are freaking out after Medicare's proposal last week to gut remote patient monitoring, or RPM. The plan is a total about-face from th…
    Endpoints · 6d ago↗ source
  • Repligen’s $1.5B buy for BioLife; BeOne’s $300M US expansion
    Plus, news about Lonza, Bachem and Samsung Biologics. 🤝 Repligen to acquire BioLife Solutions: Repligen will pay around $1.5 billion for cell processing service supplier BioLife, 36% of which will…
    Endpoints · 6d ago↗ source
  • Lilly's triple agonist heads to regulators after two more Phase 3 obesity wins
    Retatrutide, the obesity candidate that has shown the most powerful weight loss in late-stage trials, will be filed for approval early next year, its developer Eli Lilly said Thursday. The filing h…
    Endpoints · 6d ago↗ source
  • Roche says it is thoughtful on token use for AI, shelves a drug from Carmot buy
    Roche has offered some insight into how it is using AI, from drug discovery to token use. AI has already contributed to “a significant increase in new molecules” in its pipeline, CEO Thomas Schinec…
    Endpoints · 6d ago↗ source
  • Exclusive: Obesity biotech Verdiva hires ex-Metsera CMO as crucial readouts near
    Long-acting obesity pill developer Verdiva Bio has a new chief medical officer, and he comes from a biotech that was looking at very similar technology — and got bought for $10 billion not long ago…
    Endpoints · 6d ago↗ source
  • Teladoc is moving beyond its single-visit roots with new launch
    Over two decades ago, Teladoc built its business around quick doctor visits that didn't happen in person. Now, it's saying that the model of one-off virtual appointments is no longer enough. The te…
    Endpoints · 6d ago↗ source
  • Vertex was sole bidder in high-premium Crinetics acquisition
    Analysts expect new details on the lead-up to the deal “are likely to reignite” investor scrutiny that Vertex overpaid in what’s poised to be its largest-ever transaction.
    BioPharma Dive · 6d ago↗ source
  • GSK lung cancer drug gets speedy approval following $10.6B deal
    The clearance is GSK’s first for a lung cancer medicine and the latest step forward in a yearslong push by the British drugmaker into oncology.
    BioPharma Dive · 6d ago↗ source
  • FDA swiftly puts Makary era in the rearview mirror
    As the White House mulls a pick to lead the FDA, the Trump administration has been washing away the mark of former Commissioner Marty Makary, in a refresh that includes everything from reconsidered…
    Endpoints · 6d ago↗ source
  • Former FDA cancer chief Pazdur says the agency should restructure
    Richard Pazdur, who spent more than two decades leading the FDA’s cancer drug reviews, said the agency has a “golden opportunity” to restructure after being struck last year by the Trump administra…
    Endpoints · 6d ago↗ source
  • FDA approves Nuvalent's cancer drug, a week after GSK closed $10.6B buyout
    GSK's $10.6 billion acquisition of Nuvalent is delivering surprisingly early results. The FDA on Wednesday approved one of Nuvalent's lung cancer medicines two months earlier than projected, and th…
    Endpoints · 6d ago↗ source
  • FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
    The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
    fda press · 6d ago↗ source
  • Arrowhead hits ‘best-case scenario’ with latest results for fat-lowering drug
    To analysts, the drug’s apparent safety and effects on both triglyceride levels and pancreatitis cases should make it competitive with a rival Ionis therapy.
    BioPharma Dive · 6d ago↗ source
  • Arrowhead’s gene silencer competitive with Ionis’ in triglyceride disease
    Arrowhead Pharmaceuticals’ lipid-lowering drug has hit in two late-stage trials that could expand its use into a much wider population. Data shared Wednesday showed that Arrowhead’s gene silencer R…
    Endpoints · 6d ago↗ source
  • Trump threatens tariffs on imported generic drugs
    While the possibility of levies on branded pharmaceuticals have had a limited impact on drugmaker revenues, tariffs of up to 200% on copycat medicines could — depending on the specifics — prove mor…
    BioPharma Dive · 6d ago↗ source
  • Mentari adds $200M to migraine mission; Royalty's latest ATTR-CM deal
    Another $200M for Mentari: Migraine drug developer Mentari Therapeutics has lined up a second private placement as it works to close its reverse merger with InMed Pharmaceuticals. The Paragon Thera…
    Endpoints · 7d ago↗ source
  • Q&A: Lilly returns to neuropsych and looks ahead to Alzheimer's prevention
    LONDON — Eli Lilly, the world’s biggest drugmaker, appears to be getting more ambitious about tackling brain diseases. Last week, the company announced it would pay $2.8 billion upfront to acquire…
    Endpoints · 7d ago↗ source
  • Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study
    A new analysis could address some doubts investors have had about ivonescimab, one analyst said. Elsewhere, Gilead and Merck debuted data for a once-weekly HIV tablet and a new pyschedelics competi…
    BioPharma Dive · 7d ago↗ source