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  • UK regulator MHRA unveils multi-year plan to speed AI-driven drug oversight
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released a multi-year strategy aimed at keeping its regulatory framework patient-focused as artificial intelligence and persona…
    raps · 27d agoRegulatoryNeutral↗ source
  • Former FDA leaders denounce agency layoffs as historic disaster
    Three former Food and Drug Administration commissioners publicly condemned the recent staffing reductions at the agency, calling the moves a major failure of policy. Rob Califf, who served as FDA…
    STAT · 26d agoLayoffsNegative↗ source
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  • Trump administration delays rule that could curb imported prescription drugs
    The Trump administration announced a 90‑day postponement of a federal rule that would have limited Americans’ ability to purchase prescription medicines from licensed pharmacies abroad. The rule w…
    STAT · 26d agoRegulatoryPositive↗ source
  • Immune Boost Capital backs Orthrus Therapeutics to advance antigen-specific immune tolerance for rheumatoid arthritis
    Immune Boost Capital, the venture arm of the Arthritis National Research Foundation, announced an investment in Orthrus Therapeutics, a biotech focused on precision therapies for autoimmune disease…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Sanofi avoids fine as EU ends antitrust probe over alleged disparagement of rival flu vaccine
    EU antitrust regulators have closed a probe into Sanofi after the company offered concessions, allowing it to avoid a monetary penalty. The investigation centered on a campaign that allegedly port…
    STAT · 27d agoRegulatoryNeutral↗ source
  • Doctors, hospitals and insurers lobby states on medical AI regulation
    A coalition of lobbying groups representing physicians, hospitals, a health insurer and AI firms met in Washington to craft guidance for state regulation of medical AI. The group, organized by the…
    STAT · 27d agoRegulatoryNeutral↗ source
  • MIT reports 20% drop in graduate enrollment after $100 million federal research cut, warning of basic-research drought
    MIT President Sally Kornbluth told the STAT Summit that the university saw a 20% decline in new graduate students this fall, linked to a $100 million reduction in federal research awards over the p…
    STAT · 26d agoRegulatoryNegative↗ source
  • Study explores how GLP-1 weight-loss drugs affect criminal justice involvement, job prospects and housing stability
    A new research effort is looking at how GLP-1 based weight‑loss medications influence outcomes beyond health, specifically interactions with the criminal justice system, employment prospects and ho…
    STAT · 27d agoNeutral↗ source
  • Biomea posts modest Phase 1 results for oral GLP-1 drug, shares slide
    Biomea Fusion released Phase 1 data for its oral small‑molecule GLP‑1 agonist BMF‑650, positioning the program as a potential partner opportunity that could separate efficacy from gastrointestinal…
    Fierce Biotech · 27d agoNegative readoutNegative↗ source
  • Verdiva Bio halts phase 2 oral GLP-1 trial after enrolling only eight participants
    Verdiva Bio announced it is ending its phase 2 study of VRB-101, a once‑weekly oral GLP‑1 candidate, after the trial fell far short of its enrollment target. The study was intended to evaluate swi…
    Fierce Biotech · 27d agoNegative readoutNegative↗ source
  • Radical Numerics aims to develop general biological intelligence, says CEO Eric Nguyen
    STAT’s AI Prognosis newsletter features an interview with Eric Nguyen, chief executive of Radical Numerics. The Boston-based startup says it is working toward what it calls “general biological inte…
    STAT · 27d agoPositive↗ source
  • Verastem makes its stand as a RevMed competitor in pancreatic cancer
    Verastem Oncology had a big Wednesday morning: It announced new data amid a tense competition for the next-wave KRAS agents, as well as a $250 million raise and the departure of its CEO. The Massac…
    Endpoints · 26d agoNeutral↗ source
  • Early-life gut microbiome may influence lifelong brain health, experts say
    The authors argue that the composition of a baby’s gut microbiome could play a pivotal role in shaping brain development and later cognitive health. They suggest that understanding this link may he…
    STAT · 27d agoNeutral↗ source
  • Gilead signs $1.9 billion deal with Vir Biotechnology to license dual-masked T-cell engagers for oncology
    Gilead Sciences announced a licensing agreement with Vir Biotechnology to access Vir's dual-masked PRO-XTEN T-cell engager platform for oncology. Under the deal, Vir will discover, design and opti…
    Fierce Biotech · 27d agoDealPositive↗ source
  • BlackRock to acquire majority stake in Humana’s CenterWell clinics for $2.8 billion
    Humana announced that BlackRock will purchase Welsh Carson’s majority stake in the CenterWell Senior Primary Care network, a deal valued at $2.8 billion. The transaction covers roughly 150 Medicare…
    STAT · 27d agoDealPositive↗ source
  • Study finds nearly 40% of FDA advisory panels include reps linked to pharma-funded advocacy groups
    A new analysis published in Health Affairs Scholar examined FDA advisory committee meetings over the past 20 years and found that almost 40% featured a patient or consumer representative with activ…
    STAT · 27d agoRegulatoryNegative↗ source
  • iOnctura’s roginolisib shows encouraging phase 1 results in metastatic uveal melanoma
    iOnctura, a spinout of Merck KGaA, reported data from a two‑part phase 1 trial of its PI3K delta inhibitor roginolisib in patients with advanced solid and hematologic cancers, including a cohort of…
    Fierce Biotech · 27d agoPositive readoutPositive↗ source
  • Stryker invests $400 million in CMR Surgical, securing exclusive U.S. rights to Versius robotic platform
    Stryker announced a strategic investment of about $400 million in UK‑based CMR Surgical, a developer of modular, portable surgical robots. Under the agreement, Stryker will act as the exclusive U.…
    Fierce Biotech · 28d agoDealPositive↗ source
  • IQVIA and Veeva deepen partnership to accelerate clinical trial timelines
    IQVIA and Veeva Systems announced an expansion of their existing collaboration aimed at speeding up clinical trial execution and improving efficiency. The upgrade brings Veeva's trial management t…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Roche signs $1.2 bn obesity partnership with China's Rona Therapeutics, paying up to $100 m upfront
    Roche announced its seventh China deal this year, partnering with RNA‑interference specialist Rona Therapeutics to target obesity. The collaboration licenses an ALK7 inhibition asset and includes…
    Endpoints · 28d agoDealPositive↗ source
  • BioNTech’s mRNA cancer vaccine misses key endpoint in head-and-neck trial, study to continue
    BioNTech reported that its mRNA cancer immunotherapy BNT113 did not improve progression‑free survival when added to Keytruda in patients with HPV16‑positive head and neck squamous cell carcinoma. T…
    Fierce Biotech · 28d agoNegative readoutNegative↗ source
  • Roche licenses Rona's ALK7 obesity candidate in $1.2 billion deal
    Roche has agreed to license an RNAi drug candidate targeting ALK7 from Chinese biotech Rona Therapeutics, with an upfront payment of $100 million and potential milestones up to $1.06 billion. The…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Study urges regulators to adopt cloud platforms to speed drug approvals
    A new study led by Nina Cauchon of Amgen and co-authors, published in the Journal of Pharmaceutical Sciences, calls for broader use of cloud-based platforms by regulatory agencies. The authors arg…
    raps · 28d agoRegulatoryPositive↗ source
  • Verdiva Bio halts mid-stage obesity trial of its GLP-1 pill, citing market evolution
    Verdiva Bio, a well-funded private biotech, announced it has terminated one of its Phase 2 trials for its lead oral GLP-1 obesity candidate. The company said the decision reflects a shift in the m…
    Endpoints · 27d agoNegative↗ source
  • Soufflé Therapeutics raises $135 million to develop three RNA medicines
    Soufflé Therapeutics, a biotech with ties to MIT professor Bob Langer, announced a new financing round. The round raised $135 million from venture capital investors. The capital will be used to a…
    Endpoints · 27d agoDealPositive↗ source