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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
  • 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 · 19d agoPositive↗ source
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  • 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 · 19d 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 · 19d 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 · 19d ago↗ source
  • FDA approves first pediatric heart valve that expands as children grow
    The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The device is…
    fda press · 20d agoApprovalPositive↗ 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 · 20d agoPositive↗ 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 · 20d 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 · 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
  • 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 · 20d 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 · 20d 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 · 20d 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 · 20d agoRegulatoryPositive↗ source
  • Final Medicare rule to curb doctor-administered drug prices covers only four firms, delivering far less savings than proposed
    The Trump administration released a final rule intended to lower Medicare prices for drugs given in doctors' offices. The rule applies only to four pharmaceutical companies, a far narrower scope t…
    STAT · 20d agoRegulatoryNegative↗ source
  • Vertex completes $10 billion Crinetics acquisition as Q3 M&A slows
    M&A activity in the pharmaceutical sector cooled in the third quarter, with total deal value just under $30 billion across 22 transactions, according to BioSpace. Vertex Pharmaceuticals completed…
    BioSpace · 20d agoDealNeutral↗ source
  • FAIR Act could boost U.S. rare‑disease trial access and restore biotech leadership
    In a recent BioSpace podcast, host Jennifer C. Smith‑Parker talked with Max Bronstein of Aviva Strategies and Teresa Barnes of PF Warriors about a growing problem: U.S. patients are increasingly un…
    BioSpace · 20d agoRegulatoryPositive↗ source
  • UniQure’s Huntington’s gene therapy shows reduced benefit in fourth year, but patient remains optimistic
    UniQure reported new data on its experimental Huntington’s disease gene therapy, AMT-130, in a four‑year follow‑up of 12 patients. The update showed the treatment slowed disease progression by 44%,…
    STAT · 20d agoNegative readoutNeutral↗ source
  • Invivyd reports Phase 3 LIBERTY trial shows its low-dose antibody VYD2311 is safer and better tolerated than Pfizer’s Covid vaccine
    Invivyd, a small biotech focused on an injectable monoclonal antibody as an alternative to Covid vaccines, has released new data from its Phase 3 LIBERTY study. The trial compared the company’s ca…
    STAT · 20d agoPositive readoutPositive↗ source
  • AI system Claude decodes a whole genome in 30 minutes, sparking call for result standards
    The author, a Stanford physician‑scientist, used the AI model Claude to analyze his entire genome in roughly half an hour, at a cost of about five dollars. The rapid analysis produced a detailed re…
    STAT · 20d agoNeutral↗ source
  • Senate finance and health committees brace for major Republican turnover ahead of midterms
    The upcoming midterm elections are set to trigger substantial changes to two Senate committees that oversee health‑care policy. The Senate Finance Committee could see at least five of its 14 Repub…
    STAT · 20d agoNeutral↗ source