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  • Abbott nabs FDA approval, CE Mark for implantable cardioverter-defibrillator lead
    Abbott has received both FDA and CE Mark approval for its UltiSynq defibrillation lead tech, which is designed to deliver both conduction system pacing and defibrillation therapy.
    Fierce Biotech · 12h agoApprovalPositive↗ 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 · 4h agoRegulatoryNegative↗ source
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  • Merck KGaA receives FDA approval for Abbisko-licensed joint tumor therapy
    Merck KGaA announced that the U.S. Food and Drug Administration has granted approval to a drug it licensed from Chinese biotech Abbisko. The approval covers treatment of rare non-cancerous tumors t…
    Endpoints · 1h agoApprovalPositive↗ 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 · 4h agoPositive↗ source
  • Capricor cuts 10% of staff as it readies FDA decision on DMD cell therapy, NextCure trims workforce ahead of merger
    Capricor Therapeutics announced that it has reduced its workforce by about 10% during the third quarter, bringing its employee count down from 231 full‑time staff. The company said it had $198.5 mi…
    Fierce Biotech · 8h agoLayoffsNeutral↗ 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 · 4h agoRegulatoryNeutral↗ 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 · 4h agoNegative↗ source
  • VectorY bags $83.5M for antibody gene therapies in neurodegenerative diseases
    VectorY Therapeutics added €74.5 million ($83.5 million) to its Series A to fund a gene therapy that makes antibodies in the brain. The biotech’s lead asset VTx-002 is in a
    Endpoints · 30m ago↗ source
  • The U.S. may soon lose measles elimination status
    A regional WHO body will hold a four-day meeting determining whether the U.S. has maintained measles elimination. All signs point to no:
    STAT · 34m ago↗ 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 · 1d agoRegulatoryNegative↗ source
  • Beam Therapeutics reports successful pivotal trial of base editing sickle cell therapy
    Beam Therapeutics announced that its base editing treatment, ristoglogene autogetemcel (risto‑cel), met its primary goal in a pivotal trial for sickle cell disease. The trial showed the therapy cou…
    BioPharma Dive · 20h agoPositive readoutNegative↗ source
  • Beam Therapeutics reports year-long reduction in sickle cell crises in phase 1/2 risto-cel study
    Beam Therapeutics disclosed data from its phase 1/2 trial of risto-cel, a base-edited autologous cell therapy targeting the BCL11A gene in sickle cell disease. The trial enrolled 31 adults and ado…
    Fierce Biotech · 23h agoPositive readoutPositive↗ 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 · 1d agoNegative↗ source
  • 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 · 1d 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 · 20h agoDealPositive↗ source
  • Oura to buy AI virtual care firm Counsel Health for $625 million, expanding in-app health services
    Oura, known for its smart ring and health tracking, announced it will acquire Counsel Health, an AI-driven virtual primary-care provider, for $625 million in cash. The acquisition is slated to clo…
    Fierce Biotech · 22h 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 · 23h 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 · 1d agoNeutral↗ source
  • AstraZeneca acquires Omniose to boost bacterial vaccine capabilities
    AstraZeneca has completed the purchase of Omniose, a specialist in vaccine bioconjugation, making the company a wholly owned subsidiary of its infectious disease division. The two firms began coll…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Mirum's hepatitis D antibody brelovitug meets primary endpoint in phase 3 trial
    Mirum Pharmaceuticals announced that its experimental antiviral monoclonal antibody brelovitug achieved the primary efficacy goal in a phase 3 study for hepatitis D. The trial results continue a s…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • BIO proposes seven-point plan to keep US biotech ahead of China
    BIO, a major biotech lobbying organization, released a seven‑part “BioAdvance” action plan aimed at preserving U.S. leadership in biotechnology as China rolls out its own five‑year strategy. The p…
    BioPharma Dive · 1d agoRegulatoryPositive↗ 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 · 13h agoRegulatoryNeutral↗ 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 · 17h 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 · 19h 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 · 21h agoPositive readoutPositive↗ source