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  • Senate Health Committee Schedules Vote on FDA Commissioner Nominee Heidi Overton
    Senate health committee set a vote for November 18 on President Trump's nominee Heidi Overton to become FDA commissioner. The outcome will determine whether the nomination proceeds to the full Sen…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Study proposes new obesity metric that could reverse diagnoses for millions, aiming for more precise care
    Researchers published a study in Nature that suggests an alternative way to define obesity could change the diagnosis status for millions of people. The proposed framework separates pre-clinical an…
    STAT · 1d agoNeutral↗ source
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  • Incoming Democratic committee chairs move to probe Trump-era most-favored-nation drug pricing deals
    The column notes that the newly appointed Democratic chairs of key congressional committees are planning to examine the most-favored-nation (MFN) drug pricing agreements that were negotiated during…
    STAT · 1d agoRegulatoryNeutral↗ source
  • U.S. faces possible loss of measles elimination status as WHO panel convenes
    A WHO regional committee will meet for four days to decide if the United States still meets criteria for measles elimination. Current indicators suggest the country may no longer qualify, raising…
    STAT · 1d agoRegulatoryNegative↗ source
  • Federal panel overseeing preventive care receives blanket ethics waivers despite members' pharma and practice conflicts
    Federal officials granted blanket ethics waivers to every member of the U.S. Preventive Services Task Force, allowing them to serve despite clear financial conflicts of interest. Documents show so…
    STAT · 2d agoRegulatoryNegative↗ source
  • MDCalc unveils CrossCover to boost clinician confidence in AI chatbot answers while protecting privacy
    MDCalc, a medical reference website, announced a new tool called CrossCover. CrossCover is designed to check clinicians' queries for privacy issues and evaluate AI chatbot responses for accuracy,…
    STAT · 2d agoPositive↗ source
  • FDA releases draft guidance for early-phase first-in-human studies of solid-tumor therapies
    The U.S. Food and Drug Administration has issued draft guidance to help sponsors design early-phase first-in-human IND studies for investigational drugs and biologics targeting solid tumors. The g…
    raps · 2d agoRegulatoryNeutral↗ source
  • Former ER doctor argues that limiting data input can improve clinical AI tools
    Graham Walker, a former emergency‑room physician and co‑founder of MDCalc, was interviewed for STAT’s AI Prognosis newsletter about his new AI tool. Walker explains that giving AI systems only the…
    STAT · 1d agoNeutral↗ source
  • Health-care providers sue employers over out-of-network medical bills
    Providers are increasingly filing lawsuits against employers, arguing that the companies are liable for out-of-network medical charges that insurers have not fully paid or have delayed. One recent…
    STAT · 2d agoRegulatoryNeutral↗ source
  • MAHA backs convicted rapist Russell Brand, highlighting toxic culture within movement
    MAHA Action, the super PAC behind the Make America Healthy Again movement, published a lengthy defense of British comedian Russell Brand after he was sentenced to 10.5 years in prison for rape. Br…
    STAT · 1d agoNegative↗ source
  • Rising food costs and aid cuts leave low-income parents unable to risk nutritious meals for picky eaters
    Rising food prices and cuts to food assistance programs are tightening budgets for low-income families, making fruits and vegetables a less affordable option. When a child refuses a healthy item,…
    STAT · 2d agoNegative↗ source
  • 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 · 3d 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 · 3d agoNegative↗ 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 · 2d 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 · 2d 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 · 2d agoNeutral↗ source
  • Democratic committee chairs send letters to 27 drugmakers demanding details on Trump-era MFN pricing agreements
    Incoming Democratic chairs of the Senate Finance Committee and the House Energy and Commerce, Ways and Means, and Education and Labor committees have issued a new round of letters to all 27 drugmak…
    STAT · 2d agoRegulatoryNeutral↗ 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 · 2d agoRegulatoryNegative↗ source
  • Intersurgical pulls 22mm smoothbore breathing tubes after FDA warns of detaching connectors
    The FDA Center for Devices and Radiological Health issued an early alert about a potentially high‑risk issue with certain Intersurgical breathing devices. Intersurgical has sent a letter to custom…
    fda medwatch · 3d agoRegulatoryNegative↗ source
  • FDA issues early alert as Arrow International recalls guidewires with spring wire guide components
    The FDA's Center for Devices and Radiological Health has issued an early alert about a potential high‑risk issue with certain Arrow International guidewire products that contain spring wire guide c…
    fda medwatch · 3d agoRegulatoryNeutral↗ 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 · 3d agoRegulatoryPositive↗ 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 · 2d 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 · 3d 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 · 3d 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 · 2d agoRegulatoryNeutral↗ source