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3,394 stories matching this filter · ← front page

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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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ source
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  • 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo ago↗ source
  • Novartis bets up to $7.8B for an mRNA-encoded T cell engager from China’s Abogen
    Novartis is licensing an mRNA-based therapy designed to produce a CD3xCD19 T cell engager inside the body. Abogen Biosciences says the in vivo approach could reduce the likelihood of dangerous cyto…
    BioSpace · 1mo ago↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoPositive readoutPositive↗ source
  • BMS flags liver injury cases, including a death, in Phase 3 trial of pulmonary fibrosis drug admilparant
    Bristol Myers Squibb has amended the protocol for its Phase 3 pulmonary fibrosis study of admilparant after reporting several liver injury events, one of which resulted in a patient death. The comp…
    BioSpace · 1mo agoNegative↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoNegative↗ 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 · 1mo agoRegulatoryPositive↗ source
  • Foghorn Therapeutics cuts 40% of workforce after ending Lilly oncology partnership
    Foghorn Therapeutics and Eli Lilly announced the end of their 2021 oncology collaboration. The partnership had focused on developing and commercializing cancer treatments. Following the terminatio…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • FDA issues warning letter to Fresenius Kabi over famotidine injection contamination
    FDA inspectors spent three weeks at Fresenius Kabi's plant in Melrose Park, Illinois, and issued a warning letter after finding manufacturing deviations linked to patient adverse events. The issue…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Zealand Pharma shares fall as Boehringer Ingelheim partnership weight-loss drug shows modest 9.8% loss in Phase 3
    Zealand Pharma and its partner Boehringer Ingelheim reported that their glucagon/GLP-1 dual agonist survodutide met the primary endpoints in the Phase 3 SYNCHRONIZE-2 trial, but the magnitude of we…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • US government unveils AI-driven SURPASS program to accelerate clinical trials
    The U.S. Department of Health and Human Services announced that the Advanced Research Projects Agency for Health (ARPA-H) is launching four new initiatives aimed at modernizing clinical trial desig…
    BioSpace · 1mo agoRegulatoryPositive↗ source