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  • China’s five-year plan positions it to become a global leader in innovative biopharma by 2030
    China’s latest five‑year plan sets an ambitious target to turn the country into a major source of innovative medicines for the world market. Experts cited by BioSpace say the goal is within reach,…
    BioSpace · 3h agoRegulatoryPositive↗ source
  • 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 · 7h agoApprovalPositive↗ source
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  • US biotech faces growth slowdown as China’s coordinated investment threatens industry
    During a BioSpace webinar, industry experts warned that uncertainty in U.S. policy is slowing biotech growth while China accelerates its life-science sector with deliberate investment. Strand Ther…
    BioSpace · 3h agoRegulatoryNegative↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · just nowLayoffsNegative↗ source
  • Bayer's Sunharbo becomes first FDA-approved factor XIa inhibitor blood thinner
    Bayer's oral anticoagulant Sunharbo, known as asundexian, has received FDA approval, making it the first factor XIa inhibitor cleared for use in the United States. The drug is intended to lower th…
    BioSpace · 17h agoApprovalPositive↗ 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 · 23h 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 · 15h agoPositive readoutNegative↗ source
  • Beam Therapeutics' base-edited risto-cel shows 12-month pain-crisis freedom in sickle cell trial, paving way for FDA filing
    Beam Therapeutics reported that its base-edited cell therapy, risto-cel, achieved at least 12 consecutive months without severe vaso-occlusive crises in patients with sickle cell disease during a m…
    BioSpace · 17h agoPositive readoutPositive↗ 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 · 19h 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
  • FDA's new rare-disease framework faces first test with Capricor's Duchenne therapy decision
    The FDA announced a new "fit-for-purpose" rare disease framework that aims to evaluate therapies based on patient need and realistically attainable evidence. The first real test of the approach wi…
    BioSpace · 13h agoRegulatoryNeutral↗ 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 · 15h 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 · 17h 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 · 18h 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 · 19h 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 · 22h 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 · 23h 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 · 8h 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 · 13h 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 · 14h 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 · 16h agoPositive readoutPositive↗ source
  • Coherus trims workforce by 30% as Gyre Therapeutics also cuts staff after acquisition
    Coherus Oncology announced a 30% reduction in its workforce as part of a reorganization that narrows its pipeline. The cuts follow a decision to deprioritize a combination therapy across multiple…
    BioSpace · 16h agoLayoffsNegative↗ 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 · 16h agoPositive readoutPositive↗ source