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  • 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 · 1mo 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 · 1mo agoPositive↗ source
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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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ 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 · 1mo agoNeutral↗ source
  • FDA nominee Overton parries vaccine questions at Senate hearing
    Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug research.
    BioPharma Dive · 1mo ago↗ 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 · 1mo 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 · 1mo agoRegulatoryPositive↗ source
  • Roche and Ionis report positive Phase 3 interim results for IgA nephropathy drug sefaxersen
    Roche and Ionis announced that their experimental RNA therapy sefaxersen met its primary endpoint in an interim analysis of a Phase 3 trial for IgA nephropathy. The trial showed statistically sign…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • European pharma CEOs warn of biotech decline as R&D share drops to 31% and call for faster trials and stronger IP protection
    Nine leading European pharma board chairs issued an open letter warning that Europe is losing its biotech edge. They note that Europe's share of global pharma R&D fell from 43% in 1990 to 31% toda…
    BioPharma Dive · 1mo agoNegative↗ 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 · 1mo 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 · 1mo 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 · 1mo agoRegulatoryPositive↗ source
  • AI-driven biotech Enveda secures $311 million Series E to advance plant-derived drug candidates
    Enveda Biosciences, a Colorado AI drug discovery company, announced a $311 million Series E financing round, one of the larger biotech raises this year. The firm uses artificial intelligence to sc…
    BioPharma Dive · 1mo agoDealPositive↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoDealPositive↗ source
  • FDA shift sparks renewed pharma and VC focus on osteoporosis drug development
    The FDA recently altered its regulatory framework for osteoporosis medicines, prompting a wave of renewed interest across the pharmaceutical sector. Earlier, drugs from Eli Lilly, Merck, Novartis…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Insurers UnitedHealth, CVS, and Kaiser oppose Medicare's contractor ban on remote patient monitoring
    Major insurers including UnitedHealth Group, CVS Health and Kaiser Permanente have formally objected to a new Medicare proposal that would change billing for remote patient monitoring (RPM). The p…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • White House plan to tighten control over NIH grants stalls after bipartisan opposition
    A proposed executive order that would have given the White House significant authority over National Institutes of Health grant awards is now considered dead. The plan called for a commission of p…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Human‑centric testing methods promise safer, cheaper drug development but repeatability remains a key obstacle
    Regulators such as the FDA, EMA and ICH are urging drug developers to replace animal safety studies with New Approach Methodologies that use human‑relevant models. Early research shows these models…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Immunovant halts cutaneous lupus program after phase 2 failure
    Immunovant announced it is discontinuing development of its anti-FcRn antibody IMVT-1402 for cutaneous lupus erythematosus. The decision follows a mid-phase trial that did not meet its primary end…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • US to End Personal Medication Import Loophole as New Customs Rule Takes Effect
    A new regulation will begin next month that ends the longstanding loophole allowing Americans to import prescription drugs by mail. The rule, reported by the Wall Street Journal, requires any medic…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Quorum Health moves to nonprofit status as its rural hospital chain faces insolvency
    Quorum Health, a chain of mostly rural hospitals owned by private-equity investors, is in the process of converting all 11 of its facilities to nonprofit status after years of financial strain that…
    STAT · 1mo agoRegulatoryNegative↗ source