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  • BIO chief warns US biotech must act now to stay ahead of China’s new five-year plan
    John F. Crowley, CEO of the Biotechnology Innovation Organization, says China has unveiled a five-year strategy that labels biotechnology a national pillar industry and aims to overtake the United…
    STAT · 14h agoRegulatoryNegative↗ source
  • Ionis shares tumble over $1 billion as Tryngolza sales forecast cut in half
    Ionis Pharmaceuticals saw its market value drop by more than $1 billion after it lowered its sales outlook for Tryngolza, a triglyceride‑lowering therapy. The company now expects $50 million in sa…
    STAT · 23h agoNegative↗ source
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  • Bayer's asundexian receives FDA approval for stroke prevention
    Bayer announced that the U.S. Food and Drug Administration has approved its oral anticoagulant asundexian for stroke prevention. The drug is indicated to lower the risk of subsequent stroke in pati…
    Endpoints · 23h agoApprovalPositive↗ source
  • Oura to buy AI health chatbot firm Counsel Health for $625 million
    Oura announced that it will acquire Counsel Health, a startup that builds clinical artificial‑intelligence tools, for a cash price of $625 million. Counsel Health operates a conversational chatbot…
    STAT · 6h agoDealPositive↗ source
  • FDA approves Bayer's Sunharbo, a new class drug to lower stroke recurrence
    The FDA has given its nod to a Bayer medication designed to cut the risk of another stroke in patients who have already suffered one. The product, marketed as Sunharbo, belongs to a newly created…
    STAT · 9h agoApprovalPositive↗ source
  • Pharma access plans rise to 69% of late-stage drugs but gaps remain for non-communicable diseases
    A new analysis shows that many large drug makers are expanding programs to make medicines available in low- and middle‑income markets, but progress is uneven across disease areas. Access plans now…
    STAT · 10h agoNeutral↗ source
  • Mirum readies FDA filing after positive Phase 3 results for hepatitis D therapy
    Mirum Pharmaceuticals announced that its hepatitis D candidate has met its primary goals in the second of two pivotal studies. The company said the data support moving the product toward regulatory…
    Endpoints · 4h agoPositive readoutPositive↗ source
  • Former Eli Lilly sales rep sues, alleging termination after raising concerns over off-label promotion of Mounjaro for weight loss
    A former senior territory manager at Eli Lilly has filed a federal lawsuit claiming she was dismissed after reporting that the company was marketing its diabetes drug Mounjaro as a weight‑loss solu…
    STAT · 5h agoRegulatoryNegative↗ source
  • Beam Therapeutics' base-edited sickle cell therapy shows success in Phase 1/2 trial
    Beam Therapeutics announced on Tuesday that its base-edited gene therapy for sickle cell disease met its primary endpoints in a Phase 1/2 study. The trial demonstrated that a single administration…
    Endpoints · 7h agoPositive readoutPositive↗ source
  • PepGen reports positive Phase 2 data for PGN-EDODM1 in myotonic dystrophy
    PepGen disclosed that its experimental oligonucleotide therapy PGN-EDODM1 showed encouraging early signals in a Phase 2 cohort of patients with myotonic dystrophy type 1 (DM1). The company said the…
    Endpoints · 7h agoPositive readoutPositive↗ source
  • London startup Oyster Therapeutics raises $60M to develop oral tau degraders for Alzheimer’s
    Oyster Therapeutics, a London‑based biotech, announced it has closed a $60 million Series A‑2 financing round. The round was led by 4BIO Capital, a life‑science venture capital firm, with addition…
    Endpoints · 16h agoDealPositive↗ source
  • Acting FDA commissioner reports strong public interest in new expedited IND pilot
    Acting FDA Commissioner Kyle Diamantas told attendees at the Friends of Cancer Research annual meeting that the agency’s newly launched Expedited IND pilot has attracted considerable public attenti…
    raps · 23h agoRegulatoryPositive↗ source
  • Democrats demand unredacted drug pricing agreements from pharma firms after midterm victories
    Congressional Democrats have intensified scrutiny of pharmaceutical pricing agreements made under the previous administration. On Monday they sent letters to every drug maker that entered a most f…
    Endpoints · 6h agoRegulatoryNeutral↗ source
  • White House pushes Heidi Overton nomination for FDA commissioner as confirmation window narrows
    The White House is actively promoting Heidi Overton's nomination to become the commissioner of the Food and Drug Administration. Administration officials are working to gather sufficient Senate su…
    Endpoints · 8h agoRegulatoryNeutral↗ source
  • 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 · 10h 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 · 11h agoPositive readoutPositive↗ source
  • 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 · 14h 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 · 3h agoRegulatoryNeutral↗ 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 · 23h 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 · 11h 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 · 14h agoNegative↗ source
  • OpenAI’s health chief envisions ChatGPT Health moving patients from answers to actionable steps
    Nate Gross, who leads the health division at OpenAI, spoke at an Endpoints News health briefing about the company’s next steps for its AI health offering. He said the goal is to evolve ChatGPT Hea…
    Endpoints · 9h agoPositive↗ 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 · 6h agoNeutral↗ source
  • HHS Secretary RFK Jr. stays optimistic about Make America Healthy Again initiative despite midterm setbacks
    HHS Secretary Robert F. Kennedy Jr., who leads the Make America Healthy Again (MAHA) effort, addressed lawmakers on Capitol Hill this week. Throughout the year, industry observers have debated his…
    Endpoints · 1h agoPositive↗ source
  • Employers and consumers poised to reshape healthcare, says Health Tech Day discussion
    Last week the organizers held their second Health Tech Day, featuring an in‑person happy hour in New York and a live virtual stream for remote attendees. The forum focused on how employers and con…
    Endpoints · 8h agoNeutral↗ source