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  • 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 · 11h agoApprovalPositive↗ source
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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 · 17h agoRegulatoryNegative↗ 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 · 11h 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 · 13h 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
  • 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 · 7h 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 · 9h 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 · 11h 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 · 12h 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 · 13h 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 · 16h 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 · 17h 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 · 2h 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 · 8h agoRegulatoryNegative↗ 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 · 10h agoLayoffsNegative↗ source
  • PepGen's Phase 2 DM1 Data Show 46% Average Splicing Correction, Shares Jump 163%
    PepGen reported results from the 10 mg/kg multiple‑ascending‑dose cohort of its ongoing Phase 2 Freedom2‑DM1 trial, testing PGN‑EDODM1, an oligonucleotide designed to correct the molecular defect i…
    Fierce Biotech · 16h agoPositive readoutPositive↗ source
  • Deerfield Management teams with AWS to boost AI-driven life-science ventures
    Deerfield Management announced a collaboration with Amazon Web Services aimed at accelerating AI-native healthcare and life-science companies in its portfolio. The agreement links AWS's generative…
    Fierce Biotech · 23h 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 · 1d agoRegulatoryPositive↗ source
  • BIO urges US to create White House biotech office and streamline trials to stay ahead of China
    The Biotechnology Innovation Organization (BIO) released a seven-point "Bio Advance" plan aimed at strengthening the United States' biotech sector. The proposals call for easing the start-up of cli…
    BioSpace · 10h 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 · 13h agoRegulatoryNegative↗ source
  • Altimmune to discuss Phase 3 design for alcohol use disorder drug with FDA
    Altimmune is preparing to meet the FDA in December to discuss the design of a pivotal Phase 3 trial for its glucagon/GLP-1 dual receptor agonist pemvidutide. The Phase 2 RECLAIM study enrolled abo…
    BioSpace · 13h agoRegulatoryNeutral↗ 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 · 14h 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 · 17h agoRegulatoryNeutral↗ source
  • AbCellera halts development of OX40 antibody ABCL575 after phase-1 trial
    AbCellera announced it will not move ABCL575 beyond phase 1, ending its OX40 program. The phase-1 study met its endpoints, showing a favorable tolerability profile and pharmacokinetics that suppor…
    Fierce Biotech · 21h agoNegative↗ source