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  • Dutch regulators probe Biogen over exclusive MS test for Tysabri patients
    Dutch competition authority (ACM) has opened an investigation into Biogen concerning its handling of a blood test linked to its multiple sclerosis drug Tysabri. The probe focuses on whether Biogen…
    STAT · 1d agoRegulatoryNegative↗ source
  • PepGen reports promising early results for myotonic dystrophy type 1 drug in six-patient trial
    PepGen announced that its experimental therapy for myotonic dystrophy type 1 showed the most encouraging early data yet in a small study. The trial involved six patients who received the drug for 1…
    STAT · 1d agoPositive readoutPositive↗ source
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  • Democratic wins in Texas, Georgia and Wisconsin could open Medicaid expansion for over a million residents
    Three of the ten states that have not yet expanded Medicaid may revisit their stance after recent Democratic gains in state elections. Texas, Georgia and Wisconsin saw power shifts that could make…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Senators Wyden and Sanders unite on push to lower Medicare eligibility age by a decade
    Senate Finance Committee Chair Ron Wyden (D-Ore.) and Independent Senator Bernie Sanders (I-Vt.) said they are aligned on advancing a “Medicare for All” agenda. Sanders has proposed lowering the M…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Laub’s Feeding & Cubing voluntarily recalls 89 tons of mini hay cubes over botulism risk
    Laub’s Feeding & Cubing, Inc. of Beryl, Utah announced a voluntary recall of its Grade A Mini Hay Cubes. The recall covers up to 89 tons of product sold between Oct 3 and Oct 31, 2026 after the co…
    fda recalls · 1d agoCRLNegative↗ source
  • Experts urge pharma firms to build regulatory intelligence before laws take effect
    Regulatory specialists advise companies not to wait for legislation to be finalized before creating a regulatory intelligence framework. They argue that early preparation helps firms stay ahead of…
    raps · 1d agoRegulatoryNeutral↗ source
  • Flu season this year appears to be affecting teens and young adults more severely, experts say
    The article notes that flu activity this year has already resulted in at least 1.7 million reported cases, and health experts are observing that teenagers and young adults are experiencing higher r…
    STAT · 1d agoNeutral↗ source
  • Experts warn AI health advice may be accurate yet lead to poorer outcomes
    Artificial intelligence now answers hundreds of millions of health questions each week, with tools like ChatGPT fielding queries from the public at an unprecedented scale. Government officials and…
    STAT · 1d agoNegative↗ source
  • Men turn to chatbots for therapy as earnings season unfolds
    The latest STAT Health Tech newsletter notes growing optimism about mental‑health chatbots, especially among men who are less likely to seek traditional therapy. It also recaps key points from the…
    STAT · 1d agoNeutral↗ source
  • Family Farmstead Dairy recalls all cheddar cheese over possible Listeria contamination
    Family Farmstead Dairy announced a recall of all its cheddar cheese products because they may be contaminated with Listeria monocytogenes. Listeria can cause serious infections, especially in youn…
    fda recalls · 1d agoRegulatoryNegative↗ source
  • PepGen soars on promising early data for muscular dystrophy drug
    While from a small study, the findings suggest PepGen’s therapy compares favorably to other RNA-based medicines in testing at Novartis and Dyne Therapeutics.
    BioPharma Dive · 1d ago↗ source
  • STAT+: GLP-1s are given an FDA warning for rare eye condition risk
    The FDA warned that GLP-1 drugs carry a potential risk of a rare but serious eye condition sometimes referred to as an “eye stroke.”
    STAT · 1d ago↗ source
  • Recon: Bayer wins FDA approval for stroke prevention drug; Third Rock enters $2B partnership with AI-focused Chinese biotech
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1d ago↗ source
  • FDA approves Bayer’s Sunharbo, first Factor XIa inhibitor to lower stroke recurrence risk
    The Food and Drug Administration has approved Bayer's new medication intended to prevent another stroke in patients who have already experienced one. The drug, sold under the brand name Sunharbo,…
    STAT · 1d agoApprovalPositive↗ source
  • Bayer's Sunharbo receives FDA approval as first Factor XIa blood thinner
    FDA approved Bayer's new oral anticoagulant Sunharbo, marking the first U.S. approval of a Factor XIa inhibitor. The drug blocks Factor XIa, a protein that helps clots grow while playing a minor r…
    BioPharma Dive · 1d agoApprovalPositive↗ source
  • FDA warns GLP-1 weight-loss drugs may cause rare eye stroke condition
    The Food and Drug Administration issued a warning that GLP-1 drugs used for weight loss may be linked to a rare eye condition called non-arteritic anterior ischemic optic neuropathy, sometimes desc…
    STAT · 2d agoRegulatoryNegative↗ source
  • New evidence links gene‑therapy viral vectors to tumor formation in pediatric patients
    For years, scientists have debated whether the viral vectors used in gene therapy could cause cancer. Recent case reports now provide strong evidence that such a risk is real. The reports involve…
    STAT · 2d agoNegative readoutNegative↗ source
  • Argenx to acquire Unnatural Products' macrocyclic peptide platform for $550 million upfront
    Argenx announced that it will acquire the California-based protein specialist Unnatural Products, paying $550 million upfront for its macrocyclic peptide platform. The deal could rise to more than…
    BioPharma Dive · 2d agoDealPositive↗ source
  • India moves to suspend licenses of firms making substandard medicines
    The Indian government has proposed a rule that would immediately suspend the manufacturing licence of any company whose drug fails to meet quality standards. The initiative is intended to boost dr…
    raps · 2d agoRegulatoryNeutral↗ source
  • Democrats’ Midterm Wins Boost Hospital Prospects as CVS Breakup Looms
    Voters gave Democrats a decisive edge in the recent midterm elections, reshaping the political landscape for the coming year. The shift is expected to favor the hospital sector, which stands to gai…
    STAT · 2d agoPositive↗ source
  • Lilly's oral GLP-1 pill Foundayo reduces sleep apnea events in late-stage trials
    In two late-stage trials, Eli Lilly’s oral GLP‑1 pill Foundayo lowered the apnea‑hypopnea index by an average of 17.8 events per hour, compared with a 4.5‑event reduction for patients on placebo.…
    STAT · 2d agoPositive readoutPositive↗ source
  • Phase II success does not guarantee easy Phase III launch, says Thermo Fisher
    Positive Phase II data often signals the start of Phase III planning, but the transition involves far more than simply adding patients and sites. When a trial expands into new countries, differenc…
    BioPharma Dive · 2d agoNeutral↗ source
  • State incentives can shape site decisions for commercial-stage life sciences firms
    The article advises commercial-stage life-science companies to consider state and local incentives early in expansion planning to improve site selection and preserve capital. Incentives most relev…
    BioPharma Dive · 2d agoNeutral↗ source
  • Democrats weigh limits of health-care reforms after midterm win
    In the days after their sweeping midterm victories, House and Senate Democrats are debating the scope of possible health-care actions. Party leaders agree on rolling back the Medicaid cuts impleme…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Global liver experts agree on definition of acute-on-chronic liver failure
    Liver doctors from many countries have reached a common definition for acute-on-chronic liver failure, a serious complication that occurs when an existing liver disease is suddenly worsened by an a…
    STAT · 2d agoPositive↗ source