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  • ICMRA urges cut to animal testing while HHS launches ARPA-H SURPASS program to accelerate clinical trials
    International Coalition of Medicines Regulatory Authorities released a joint statement urging drug makers and national control labs to cut back on animal testing throughout a medicine’s development…
    raps · 20d agoRegulatoryNeutral↗ source
  • HHS unveils ARPA-H SURPASS program to accelerate clinical trial design
    The U.S. Department of Health and Human Services announced a new initiative under ARPA-H called the Simulation‑augmented, Real‑time Platform Adaptive Seamless Trials (SURPASS) program. SURPASS is…
    raps · 20d agoRegulatoryPositive↗ source
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  • Reporter visits Shanghai to see China’s fast‑growing biotech sector as Chinese‑designed drugs make up about half of the global pipeline
    A STAT+ correspondent traveled to Shanghai to get a first‑hand view of the rapid expansion of China’s biotech industry. The piece describes the bustling research environment and the growing number…
    STAT · 19d agoNeutral↗ source
  • Blue Shield of California plans to adopt Medicare-inspired chronic-care payment model by 2027
    Blue Shield of California, which serves about 6 million members, is among 17 major health plans that have pledged to adopt payment models based on the Medicare Innovation Center's ACCESS Model. Th…
    STAT · 19d agoNeutral↗ source
  • Upcoming FDA decisions in Q3 2026 could signal agency flexibility
    The piece highlights five FDA actions slated for the third quarter of 2026 that industry participants are tracking. Observers say the outcomes may reveal how flexible the agency will be under its…
    BioPharma Dive · 19d agoRegulatoryNeutral↗ source
  • Podcast examines growing US mistrust in science and a new gene-editing lawsuit
    The latest episode of The Readout LOUD, a weekly biotech podcast, focused on the erosion of public confidence in science. Hosts Adam Feuerstein, Elaine Chen, and Allison DeAngelis spoke with STAT’…
    STAT · 19d agoNeutral↗ source
  • CDC plans to drop disability questions from health survey, sparking concerns of undercounting
    The Centers for Disease Control and Prevention is proposing a redesign of the National Health Interview Survey that would eliminate questions about disabilities. The change is part of a broader eff…
    STAT · 19d agoRegulatoryNegative↗ source
  • Trump administration appeals court decision that blocks limits on international student and postdoc visas
    The Department of Homeland Security has filed an appeal after a federal judge ruled that the agency cannot impose new restrictions on how long international students and postdoctoral researchers ma…
    STAT · 19d agoRegulatoryNeutral↗ source
  • STAT+: MAHA goes corporate
    Health care companies dominate the MAHA Summit, and a look at Trump's watered down effort to lower Medicare drug prices.
    STAT · 19d ago↗ source
  • Eli Lilly’s Zepbound plus amylin candidate shows 23% weight loss in phase 2 trial, but many patients stopped treatment
    Eli Lilly tested a combination of its GLP‑1 obesity drug Zepbound with the amylin‑targeting candidate eloralintide in a mid‑stage study of people with obesity and type 2 diabetes. After 48 weeks,…
    STAT · 20d agoPositive readoutNeutral↗ source
  • UnitedHealth lawsuit proceeds as judge rejects motion to dismiss earnings manipulation claims
    A federal judge allowed an investor lawsuit against UnitedHealth Group to continue, rejecting the company's request to throw out the case. The suit alleges UnitedHealth inflated its 2024 earnings…
    STAT · 20d agoRegulatoryNegative↗ source
  • Trump administration's final Medicare pricing rule limits savings, covering only four firms
    The Trump administration released a final rule intended to lower Medicare prices for drugs administered in physician offices. The rule is part of the Global Benchmark for Efficient Drug Pricing (GL…
    STAT · 20d agoRegulatoryNegative↗ source
  • HHS launches SURPASS program to accelerate clinical trials using AI and adaptive designs
    HHS announced a new five-year initiative called SURPASS, aimed at speeding up and expanding clinical trials by leveraging artificial intelligence and computational modeling. The program, run throu…
    STAT · 20d agoRegulatoryPositive↗ source
  • Bristol Myers revises Phase 3 fibrosis trial after liver safety events, including a death
    Bristol Myers Squibb announced a change to its late-stage Phase 3 "Aloft" trial of the experimental pulmonary fibrosis drug admilparant. The amendment adds closer monitoring for liver-related adve…
    BioPharma Dive · 20d agoNegative readoutNegative↗ source
  • FDA begins review of Roche’s experimental multiple sclerosis pill fenebrutinib
    The FDA has accepted Roche's application for fenebrutinib, an experimental oral therapy for multiple sclerosis, and has started a priority review. The review will evaluate the drug in both relapsi…
    BioPharma Dive · 20d agoRegulatoryNeutral↗ source
  • U.S. plan to cut Medicaid for legal immigrants, including refugees and trafficking victims, takes effect Oct. 1
    Hundreds of thousands of lawfully present immigrants could lose Medicaid coverage beginning Oct. 1, according to state data. The change is part of the One Big Beautiful Bill Act, a Republican effor…
    STAT · 20d agoRegulatoryNegative↗ source
  • PhRMA appoints former congressman Eric Cantor as CEO as Pierre Fabre resubmits Ebvallo approval request
    PhRMA announced that former U.S. House member Eric Cantor will become its president and chief executive on Nov 9, taking over from longtime leader Steve Ubl. Cantor served Virginia from 2000 to 201…
    BioPharma Dive · 20d agoRegulatoryNeutral↗ source
  • Poll finds most rural MAHA supporters say Trump health policies have not improved community health
    A new Associated Press‑KFF poll of more than 2,000 rural registered voters shows that while about half of respondents identify with the Make America Healthy Again (MAHA) movement, roughly eight in…
    STAT · 20d agoNegative↗ source
  • Beam sues over alleged IP theft as Moderna appoints new COO and Pierre Fabre/Atara refile drug for ultra-rare blood cancer
    Beam Therapeutics has filed a lawsuit claiming a former scientist took proprietary information and used it to start a Chinese firm, alleging theft of its intellectual property. PhRMA announced a n…
    STAT · 20d agoRegulatoryNeutral↗ source
  • AI chemistry agent gives wrong answer after handling malformed data, highlighting safety concerns in drug research
    An AI chemistry agent called ChemAgent was tasked with checking whether a molecule had a known hepatobiliary side effect. The agent supplied the molecular structure in an invalid format to a speci…
    BioPharma Dive · 20d agoNegative↗ source
  • US must strengthen its biotech sector to stay ahead of China, authors argue
    Gary Locke and Patrick McHenry, former U.S. officials and senior advisers to the American Biosecurity Initiative, argue that the United States must invest in its own biotech capabilities to preserv…
    STAT · 20d agoPositive↗ source
  • FDA seeks new advisory committee members, signaling renewed focus on external expertise
    The FDA announced it is inviting subject‑matter experts and consumer representatives to serve on its advisory committees. The call follows a period when the advisory committees had a reduced role…
    raps · 21d agoRegulatoryNeutral↗ source
  • Beam Therapeutics files lawsuit accusing former scientist of stealing IP to launch Chinese biotech venture
    Beam Therapeutics has initiated legal action alleging that a former employee misappropriated proprietary gene-editing technology. The company claims the scientist used the stolen information to co…
    STAT · 20d agoCRLNegative↗ source
  • Industry groups back FDA draft guidance on single‑trial approvals but seek clearer flexibility rules
    Industry associations and other stakeholders have expressed overall support for the FDA's draft guidance that outlines when a single pivotal trial, supplemented by confirmatory evidence, can be suf…
    raps · 21d agoRegulatoryNeutral↗ source
  • Researchers create mouse with human-derived brain cortex, sparking ethical and scientific debate
    A research team led by Stanford professor Sergiu Pașca has reported in Nature the creation of a laboratory mouse whose cerebral cortex is built from human brain cells derived from stem cells. The s…
    STAT · 20d agoNeutral↗ source