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  • FDA device center outlines FY 2027 guidance agenda, focusing on AI devices and change control plans
    The FDA's Center for Devices and Radiological Health announced its guidance priorities for fiscal year 2027 on Oct 1. The top items are finalizing guidance on artificial intelligence‑enabled medic…
    raps · 19d agoRegulatoryNeutral↗ source
  • Summit Therapeutics partners with AstraZeneca and Daiichi Sankyo on cancer trial; Eccogene hits $50 million milestone
    Summit Therapeutics announced a partnership with AstraZeneca and Daiichi Sankyo to evaluate its Trop-2‑directed antibody‑drug conjugate in a clinical trial. The collaboration will involve joint de…
    Endpoints · 18d agoDealPositive↗ source
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  • Pharmacist urges law to modernize 340B discounts for multi-use orphan drugs
    A pharmacist argues that current legislation lags behind the evolving use of orphan-designated medicines, many of which now serve multiple therapeutic indications. The piece highlights the 340B dr…
    STAT · 19d agoRegulatoryNegative↗ source
  • FDA device center outlines FY 2027 guidance plan, targeting AI-enabled devices and change-control plans
    On Oct 1, the FDA’s Center for Devices and Radiological Health announced its guidance agenda for fiscal year 2027. The top priority is finalizing guidance for artificial intelligence-enabled medic…
    raps · 19d agoRegulatoryNeutral↗ source
  • Geneticist Mary-Claire King awaits Nobel call after pioneering BRCA discovery
    STAT spoke with geneticist Mary-Claire King, whose discovery of the BRCA1 and BRCA2 cancer mutations three decades ago has become a landmark in oncology. King recalled being invited to give a semi…
    STAT · 18d agoPositive↗ source
  • NIH launches streamlined website consolidating 700 sites into eight thematic hubs
    NIH announced a new version of its public website that reorganizes content from more than 700 separate sites into eight thematic hubs. The hubs cover health, research, data, clinical studies, rare…
    STAT · 18d agoPositive↗ source
  • SonoThera appoints former BridgeBio chief medical officer Adam Shaywitz
    STAT+ columnist Ed Silverman notes that the pharmaceutical industry continues to see staff changes, with a regular feature highlighting individual moves. SonoThera announced the hiring of Adam Sha…
    STAT · 18d agoNeutral↗ source
  • Doctor urges marathon organizers to adopt evidence-based heat-stroke plans as climate change raises temperatures
    A physician who treated a runner for heat stroke at the New York City Marathon says the event highlighted how extreme heat can overwhelm existing medical preparations. He urges marathon organizers…
    STAT · 19d agoNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about the 340B drug pilot program, an obesity drug disappointment, and more
    The U.S. approved 10 drugmakers to participate in a 340B pilot program that will allow them to offer rebates, instead of upfront discounts, to certain providers
    STAT · 18d ago↗ source
  • Sanofi to pay $1 billion upfront to expand antibody partnership with Regeneron
    Sanofi announced it will provide Regeneron with a $1 billion upfront payment to broaden their existing antibody collaboration. The agreement is timed as the patent protection for Dupixent, the joi…
    Endpoints · 20d agoDealNeutral↗ source
  • Medicare Advantage plans to raise out-of-pocket costs and cut benefits for 2027 enrollees
    Medicare Advantage insurers are set to increase out-of-pocket expenses for seniors enrolling in 2027 plans. The changes include higher cost‑sharing, reduced coverage for dental and other services,…
    STAT · 19d agoNegative↗ source
  • Science journal launches special issue on women’s health, spotlighting menopause and chronic pain
    Science announced a new special issue dedicated to women’s health, released on Thursday. The collection brings together research on topics ranging from menopause to chronic pain, aiming to raise aw…
    STAT · 19d agoPositive↗ source
  • Eli Lilly, Novo, AbbVie and Boehringer showcase new obesity drug data at European meeting
    The European Association for the Study of Diabetes held its annual meeting in Milan, drawing obesity and metabolic disease experts and providing a platform for drugmakers to present emerging weight…
    BioPharma Dive · 19d agoPositive readoutPositive↗ source
  • Sanofi, Regeneron expand partnership with $1 billion deal to develop next-generation Dupixent-like antibodies
    Sanofi and Regeneron announced they have broadened their long‑standing alliance, adding a $1 billion upfront payment to fund joint work on new immune‑modulating drugs. The revised agreement calls…
    BioPharma Dive · 19d agoDealPositive↗ source
  • Pfizer's experimental eczema drug tilrekimig shows strong skin clearance in Phase 2 trial
    Pfizer reported that its three‑pronged antibody, tilrekimig, met the primary endpoint of its Phase 2 study in patients with moderate to severe atopic dermatitis. After 16 weeks, a significantly hig…
    BioPharma Dive · 19d agoPositive readoutPositive↗ source
  • Devoted Health secures $1.2 billion in new funding to fuel senior member growth
    Devoted Health, a Medicare Advantage insurer and medical group, announced a fresh capital injection of nearly $1.2 billion. The financing round includes a $555 million Series G investment along wi…
    Endpoints · 19d agoDealPositive↗ source
  • Study finds GLP-1 weight-loss drugs appear safe and effective for children with severe obesity
    A transplant surgeon and obesity‑medicine specialist at NYU Langone reports that his research on GLP-1 weight‑loss drugs in children yields reassuring results. He notes that many of his transplant…
    STAT · 20d agoPositive↗ source
  • Chinese biotech firms showcase rapid drug development at Shanghai Science City conference
    Jefferies hosted its first investor conference in Shanghai’s high‑tech Science City district, gathering leaders of several fast‑growing Chinese biotech companies on a stage at the Hilton ballroom.…
    STAT · 20d agoPositive↗ source
  • Sanofi and Regeneron deepen collaboration, adding new immunology antibody program
    Sanofi and Regeneron announced an expanded partnership that builds on the success of their joint drug Dupixet, targeting a pipeline of experimental antibodies for immunological disorders. Under th…
    STAT · 20d agoDealPositive↗ source
  • HHS unveils ARPA-H SURPASS program to accelerate clinical trial design
    On Oct 1, 2026 the U.S. Department of Health and Human Services announced a new initiative under the Advanced Research Projects Agency for Health. The initiative, named the Simulation-augmented, R…
    raps · 20d agoRegulatoryNeutral↗ source
  • EU Council adopts new pharma package to modernize drug legislation
    The Council of the European Union has approved a comprehensive "pharma package" of rules aimed at updating the regulatory framework for medicines across the bloc. The new legislation seeks to stre…
    raps · 20d agoRegulatoryNeutral↗ source
  • Lilly ends partnership with Foghorn after lead cancer drug fails efficacy tests
    Lilly announced it is ending its collaboration with Foghorn Therapeutics after the biotech's lead cancer candidate, FHD-909, did not meet efficacy benchmarks in testing. The decision halts the join…
    BioPharma Dive · 19d agoNegative↗ source
  • United Therapeutics wins Delaware court case; BMS secures pediatric approval for Camzyos
    United Therapeutics secured a legal victory in a federal court in Delaware, with the judge ruling in the company's favor. The decision marks a notable win for the biotech firm, though the specific…
    Endpoints · 19d agoApprovalNeutral↗ source
  • HHS launches funding programs to accelerate U.S. clinical trials amid rising Chinese competition
    HHS announced new initiatives aimed at speeding up clinical trial development in the United States. The department introduced a five-year program called "Surpass" that seeks proposals from teams wi…
    BioPharma Dive · 19d agoRegulatoryPositive↗ source
  • Eli Lilly ends partnership with Foghorn Therapeutics, prompting 40% staff cut at biotech
    Eli Lilly announced it is withdrawing from its collaboration with Foghorn Therapeutics on a synthetic lethality drug program. Following the pullback, Foghorn said it will cut roughly 40% of its wo…
    Endpoints · 19d agoDealNegative↗ source