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  • FDA places second clinical hold on Regenxbio’s Hunter syndrome gene therapy after spinal masses detected
    The FDA issued another clinical hold on Regenxbio’s RGX-121 gene therapy for Hunter syndrome after investigators found spinal masses in five trial participants. The masses, observed on MRI scans,…
    BioPharma Dive · 1h agoRegulatoryNegative↗ source
  • Roche's Genentech signs up to $2.3B deal with Hanmi for weight-loss drug that preserves lean mass
    Roche, through its Genentech subsidiary, has entered a licensing agreement with South Korea's Hanmi Pharm that could be worth up to $2.3 billion, including a $190 million upfront payment. The deal…
    BioSpace · 4h agoDealPositive↗ source
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  • FDA places hold on REGENXBIO's Hunter syndrome gene therapy after spinal nodules found, company pauses resubmission
    The FDA placed a clinical hold on RGX-121, REGENXBIO's gene therapy for Hunter syndrome, after MRI scans showed small nodules or cystic masses in the spines of five trial participants. The finding…
    BioSpace · 3h agoRegulatoryNegative↗ source
  • Lady Gaga and fiancé announce new biotech startup as FTC eyes Amgen patents and Moderna-Merck vaccine advances
    Lady Gaga and her fiancé have announced the formation of a new biotech startup, marking a rare foray of a pop culture figure into the life‑science sector. The Federal Trade Commission has begun a…
    STAT · 2h agoNeutral↗ source
  • FDA pauses Regenxbio gene therapy trial for Hunter syndrome after spinal masses found
    The Food and Drug Administration has placed another hold on Regenxbio's gene-therapy trial for mucopolysaccharidosis type II, also known as Hunter syndrome, after new safety concerns emerged. Five…
    STAT · 5h agoRegulatoryNegative↗ source
  • Roche commits $190 million upfront to license Hanmi's early-stage muscle-building obesity drug, total deal up to $2.3 billion
    Roche announced it will pay $190 million upfront to license an early-stage obesity drug from South Korean company Hanmi Pharm. The compound is described as a non-incretin, muscle-building therapy a…
    Endpoints · 6h agoDealPositive↗ source
  • Option-to-acquire structures stay uncommon amid biotech's busy M&A season
    Biotech companies are experiencing one of the busiest deal-making years on record, with a flood of announced mergers and acquisitions. Two recent transactions have highlighted the option-to-acquir…
    Endpoints · 6h agoDealNeutral↗ source
  • Pharma marketers urged to adopt share-of-answer strategy as AI use surges among physicians
    Pharma marketers are planning for 2027 as artificial intelligence reshapes how clinicians seek clinical answers. The rise of AI tools means that traditional metrics like share of voice and broad om…
    BioPharma Dive · 8h agoNeutral↗ source
  • FDA to Issue Formal Guidance on Regulating Generative AI Medical Devices
    The Food and Drug Administration announced that it is creating a plan to regulate medical devices that incorporate generative artificial intelligence. Rick Abramson, director of the agency’s Digita…
    STAT · 8h agoRegulatoryPositive↗ source
  • Trump administration rule bars Medicaid payment for pediatric gender-affirming meds, could set broader coverage precedent
    The Centers for Medicare & Medicaid Services released a final rule that prohibits the use of federal Medicaid and CHIP funds for pediatric gender-affirming medications and related surgeries. The ru…
    STAT · 8h agoRegulatoryNegative↗ source
  • FDA’s new leadership aims to restore reliability, but each application remains judged on its data
    The FDA’s current leadership is working to rebuild the agency’s reputation for reliability, integrity and transparency after a turbulent period under former commissioner Marty Makary. Recent actio…
    BioSpace · 13h agoRegulatoryNeutral↗ source
  • Medicaid coverage for GLP-1 weight-loss drugs stalls, only Indiana signs on
    President Trump pledged to broaden Medicaid access to costly GLP-1 obesity medications by letting states negotiate prices directly with manufacturers. The rollout depended on state participation,…
    STAT · 3h agoRegulatoryNegative↗ source
  • FDA signals upcoming rules for generative AI use in drug development
    The FDA announced it intends to create regulatory guidance for the use of generative artificial intelligence in pharmaceutical research and development. The move follows growing interest in AI too…
    STAT · 4h agoRegulatoryNeutral↗ source
  • Cardio firms including AstraZeneca and Novartis to showcase heart drug data at ESC 2026
    At the European Society of Cardiology's annual meeting in 2026, several pharmaceutical companies will present cardiovascular data. The lineup includes AstraZeneca, Ionis, Cytokinetics, Novartis an…
    Endpoints · 2h agoNeutral↗ source
  • Aon warns 2027 will bring steep rise in employer health premiums, highlighting data gaps for public-sector plans
    Aon’s chief actuary warned that 2026 data points to a harsh 2027 for employer-sponsored health insurance premiums, with costs expected to rise sharply. The firm said employers will need better dat…
    STAT · 2h agoNegative↗ source
  • Health Secretary Kennedy criticizes CDC vaccine classification scheme and shared decision-making category
    Robert F. Kennedy Jr., serving as Health Secretary, has raised concerns about how the CDC categorizes vaccine recommendations. The CDC uses three categories: routine recommendations for universal…
    BioSpace · 5h agoRegulatoryNegative↗ source
  • Boehringer Ingelheim pauses Phase 1 study of oral candidate BI 3031185 after safety event
    Boehringer Ingelheim has placed a Phase 1 study of its oral candidate BI 3031185 on hold after a safety event was identified. The trial, run in Japan with healthy volunteers, was assessing tolerab…
    BioSpace · 5h agoCRLNegative↗ source
  • Study finds SNAP soda bans cut purchases by 12% among beneficiaries
    A new study shows that purchases of soda fell by roughly 12% among people receiving Supplemental Nutrition Assistance Program benefits after the bans on soda and candy took effect in ten states. Th…
    STAT · 12h agoRegulatoryPositive↗ source
  • Season 2 of The Progress Profile podcast spotlights Alzheimer’s research and patient-centered trial design
    The Progress Profile: Alzheimer’s Research in Focus returns for a second season, offering conversations about Alzheimer’s disease and brain health. In the premiere episode, Dr. John Harrison, Dr.…
    BioPharma Dive · 5h agoNeutral↗ source
  • Handshakes in the ER: A simple gesture can ease patient anxiety
    An emergency medicine resident at Northwestern University recounts a recent shift where a patient faced a suspected oncologic emergency. The physician introduced herself with a handshake to the pat…
    STAT · 8h agoPositive↗ source
  • Nurse practitioner students struggle to find clinical preceptors, often paying thousands
    Nurse practitioner graduate programs require students to complete at least 500 hours of supervised patient care with a licensed preceptor. Across the United States, a shortage of qualified precepto…
    STAT · 8h agoNegative↗ source
  • Retired cardiologist finds new purpose volunteering at Maryland community clinic, highlights gaps in US health care
    A cardiologist who spent nearly four decades in private practice retired in 2022 and soon after began volunteering at a nonprofit community clinic in Maryland. The clinic serves the "working poor"…
    STAT · 8h agoNeutral↗ source
  • DC judge rejects Merck’s IRA case more than three years after it was filed
    After lengthy consideration, a DC federal judge on Monday rejected Merck’s challenge to Medicare drug price negotiations. Judge Colleen Kollar-Kotelly of the US District Court for the District of C…
    Endpoints · 30m ago↗ source
  • FDA extends review of Capricor cell therapy; Pain drug startup to go public
    The agency is now reviewing an updated application for deramiocel with a “refined” indication. Elsewhere, a startup co-founded by Vivek Ramaswamy is taking a speedy path to the public markets.
    BioPharma Dive · 1h ago↗ source
  • Capricor’s Duchenne therapy has new life after FDA grants 3-month extension
    The FDA has granted a three-month extension for Capricor Therapeutics’ Duchenne muscular dystrophy hopeful deramiocel in order to review additional data and consider a refined indication. The new t…
    BioSpace · 1h ago↗ source