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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 · 13h agoApprovalPositive↗ source
  • BioNTech spends $205 million on FDA priority review voucher to accelerate oncology pipeline
    BioNTech has agreed to pay $205 million to acquire an FDA priority review voucher, a tool that can shorten the agency's standard review period from ten months to six months. The voucher was previo…
    Fierce Biotech · 6h agoDealPositive↗ source
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  • VectorY Therapeutics raises $83.5M Series A to develop brain-targeted antibody gene therapy
    VectorY Therapeutics announced it has closed a Series A financing round, adding €74.5 million ($83.5 million) to its capital. The funds will be used to advance its lead gene-therapy candidate VTx-…
    Endpoints · 1h agoDealNeutral↗ 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 · 1h 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 · 5h agoRegulatoryNegative↗ source
  • 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 · 2h 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 · 5h 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 · 9h agoLayoffsNeutral↗ source
  • Amgen builds Sjögren’s case with detailed phase 3 data ahead of Novartis showdown
    Amgen has shared more data from a phase 3 Sjögren’s disease trial that dazzled analysts, digging into the details that could shape its showdown with Novartis.
    Fierce Biotech · 10h agoDealNeutral↗ source
  • UK science minister urges life-science firms to boost domestic investment as government raises medicine spending
    At a Financial Times Global Pharma and Biotech Summit, the UK science minister highlighted the need for greater domestic investment in life-science companies. The call follows a recent increase in…
    Endpoints · 54m agoPositive↗ 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 · 5h 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 · 5h 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 · 1d agoRegulatoryNegative↗ 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 · 1d 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 · 21h 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 · 23h 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 · 1d 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
  • 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 · 14h 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 · 19h 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 · 20h agoRegulatoryNegative↗ source