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  • China NewCo model pioneer sued in US over alleged trade secret theft and double-dealing
    A lawsuit filed in New York and later moved to federal court accuses Su Zhang, a consultant known for shaping the China "NewCo" dealmaking model, of misusing trade secrets and engaging in double-de…
    Fierce Biotech · 26d agoNegative↗ source
  • FDA nominee Heidi Overton affirms safety of vaccines and mifepristone in Senate hearing
    Heidi Overton, the Trump administration’s pick for FDA commissioner, appeared before the Senate Health, Education, Labor and Pensions Committee to answer questions about her views on key public‑hea…
    Fierce Biotech · 27d agoRegulatoryNeutral↗ source
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  • STAT's The Readout LOUD podcast goes international with a Shanghai dispatch on China's biotech surge
    The Readout LOUD podcast, part of STAT's weekly biotech series, is expanding its reach beyond the United States this week. Host Jason Mast reports from Shanghai, where he examines how China's growi…
    STAT · 26d agoNeutral↗ source
  • Senate Finance Committee Advances Chris Klomp’s HHS Deputy Nomination
    The Senate Finance Committee voted Thursday to move Chris Klomp’s nomination for deputy secretary of the Department of Health and Human Services forward to the full Senate. The 15-12 vote saw all…
    STAT · 26d agoRegulatoryNeutral↗ source
  • Travere appoints former Amicus CEO Bradley Campbell as new chief executive
    Travere Therapeutics CEO Eric Dube is stepping down after overseeing the launch of the rare kidney disease drug Filspari. Bradley Campbell will assume the role on Dec 1, bringing experience from l…
    Fierce Biotech · 27d agoNeutral↗ source
  • Measles deaths rise as U.S. sees worst outbreak since 1991, CDC reports four fatalities in Pennsylvania
    The Centers for Disease Control and Prevention has added a measles death to its online counter, highlighting a recent increase in fatalities. State officials in Pennsylvania say four unvaccinated…
    STAT · 27d agoNegative↗ source
  • Physician who survived measles warns of rising U.S. cases and deaths
    Jewel Mullen, an associate professor at Dell Medical School, recalls surviving a near-fatal measles infection as a kindergartener in 1961, before a vaccine existed. Her personal ordeal and decades…
    STAT · 27d agoNegative↗ source
  • Radiology practices increasingly develop and market in-house AI, branding themselves as AI-native
    Radiology groups, especially outpatient and teleradiology firms, are moving beyond using third‑party AI tools and are building their own algorithms within the practice. By keeping development in‑h…
    STAT · 27d agoPositive↗ source
  • Merck sees pivotal victory for $3B eye disease prospect
    Merck & Co.’s Brunello trial has hit its primary endpoint, shedding light on the effects of a trispecific diabetic macular edema (DME) drug candidate that the Big Pharma bought in a $3 billion take…
    Fierce Biotech · 27d agoRegulatoryNeutral↗ source
  • EMA leaders say single pivotal trial should not be default, decision must match evidence needed
    EMA chief Emer Cooke and other officials weighed in on the ongoing debate about the number of pivotal trials required for drug approval. They argued that requiring a single pivotal trial as a rigi…
    raps · 27d agoRegulatoryNeutral↗ source
  • Trump administration claims all states will join Medicaid drug pricing program, but several states remain undecided
    White House officials announced that every U.S. state had agreed to participate in a new federal Medicaid drug pricing initiative, describing it as a "good deal" for states. State officials, howev…
    STAT · 27d agoRegulatoryNeutral↗ source
  • Senators Question FDA Nominee Overton as Agency Issues New Rule to Cut Animal Testing
    Senators on the Senate Health Committee interrogated President Trump's nominee to lead the FDA, Dr. Janet Overton, during her confirmation hearing. Lawmakers focused on her views about the agency's…
    raps · 27d agoRegulatoryNeutral↗ source
  • Senate grills Trump’s FDA nominee Heidi Overton on agency priorities
    Heidi Overton, President Trump’s nominee to lead the U.S. Food and Drug Administration, appeared before the Senate for a confirmation hearing on September 24, 2026. Senators from both parties aske…
    raps · 27d agoRegulatoryNeutral↗ source
  • Galil Importing Corp recalls Lior ground cinnamon over elevated lead levels
    Galil Importing Corp of Hauppauge, New York announced a recall of its Lior Cinnamon Ground Seasoning because of potential elevated lead contamination. The product, distributed to retail outlets in…
    fda recalls · 26d agoRegulatoryNegative↗ source
  • Deano’s Pasta recalls 20 lbs of ravioli over undeclared lobster allergen
    Deano’s Pasta of Somerville, Massachusetts announced a recall of its Pear and Pecorino Triangoli Ravioli after discovering the product may contain undeclared lobster, a crustacean shellfish allerge…
    fda recalls · 26d agoRegulatoryNegative↗ source
  • Radiology startups say owning clinics speeds AI tool development as insurers resist new RPM rules
    Radiology startups argue that owning their own imaging practices gives them direct access to patient scans and workflow data, which they say accelerates the creation and testing of artificial‑intel…
    STAT · 27d agoNeutral↗ source
  • Roche reports phase 3 success for sefaxersen in IgA nephropathy, eyes accelerated approval
    Roche announced that its experimental drug sefaxersen met the primary endpoint in a phase 3 trial for IgA nephropathy, showing reduced proteinuria versus placebo. The interim analysis at week 37 d…
    Fierce Biotech · 28d agoPositive readoutPositive↗ source
  • FDA nominee Heidi Overton pledges faster drug trials to keep US biotech competitive
    Heidi Overton, President Trump's nominee for FDA commissioner, will appear before a Senate committee to outline her priorities for the agency. She said the administration wants her to 'go fast,' a…
    STAT · 27d agoRegulatoryPositive↗ source
  • Boston biotech seed funding drops 40% as investors favor later-stage firms
    Boston remains the world’s largest biotech hub, but early‑stage startups are feeling a sharp squeeze in capital. The average seed round for a pre‑clinical company in Massachusetts fell to $4.65 mi…
    Fierce Biotech · 28d agoNegative↗ source
  • Enveda Biosciences raises $311 million in Series E to accelerate nature-derived drug development
    Enveda Biosciences announced a $311 million Series E financing round, adding to the more than $500 million it has raised in previous rounds. The new capital follows a $130 million Series C in Nove…
    Fierce Biotech · 28d agoDealPositive↗ source
  • FDA advisory panel backs Grail's Galleri multi-cancer blood test, citing benefits outweigh risks
    The Food and Drug Administration’s advisory committee voted to endorse Galleri, a blood test from Grail that screens for multiple cancers, saying the benefits outweigh the risks. The panel’s vote…
    STAT · 27d agoRegulatoryPositive↗ source
  • Kyverna reports year-long efficacy and clean safety for miv-cel CAR-T in autoimmune trials
    Kyverna Therapeutics released one-year data for its CAR-T candidate miv-cel in stiff person syndrome and 18-month data in generalized myasthenia gravis. The single dose showed durable clinical ben…
    Fierce Biotech · 27d agoPositive readoutPositive↗ source
  • Flagship Pioneering secures Pentagon contract to develop biological threat countermeasures
    Flagship Pioneering, a biotech investment firm, has been awarded a contract by the U.S. Department of Defense. The contract aims to advance technologies that can serve as countermeasures against b…
    STAT · 28d agoDealPositive↗ source
  • US HHS and FDA announce new rules to expand non-animal testing methods as legal battles over youth gender-affirming care continue
    The legal landscape for youth gender‑affirming care remains turbulent, with the Trump administration's aggressive stance prompting dozens of hospitals nationwide to halt such services, even in the…
    STAT · 28d agoRegulatoryNeutral↗ source
  • Boehringer Ingelheim boosts Variant Bio partnership with $250 million for cardiovascular research
    Boehringer Ingelheim announced an expansion of its collaboration with Variant Bio. The partnership will now include cardiovascular disease research, broadening its original scope. The deal value…
    Fierce Biotech · 28d agoDealPositive↗ source