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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 · 21h 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 · 17h agoPositive readoutPositive↗ source
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  • 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
  • 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 · 13h 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 · 15h 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 · 16h 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 · 17h 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 · 20h 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 · 21h 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 · 6h 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 · 12h agoRegulatoryNegative↗ 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 · 20h agoPositive readoutPositive↗ 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 · 1d 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 · 1d agoRegulatoryNeutral↗ 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 · 1d 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
  • 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 · 17h 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 · 18h 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 · 21h 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 · 1d agoNegative↗ source
  • Coherus Oncology cuts 30% of staff to focus on esophageal cancer combo
    Coherus Oncology announced another round of layoffs, reducing its workforce by about 30% as it narrows its development program. The cuts follow the presentation of phase 1b data on a combination o…
    Fierce Biotech · 1d agoLayoffsNeutral↗ source
  • Novocure's Optune Mya device denied FDA approval over efficacy concerns
    Novocure received a "not approvable" letter from the FDA for its Optune Mya system, which was being evaluated for patients with brain metastases from non‑small cell lung cancer after stereotactic r…
    Fierce Biotech · 1d agoRegulatoryNegative↗ 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 · 10h agoRegulatoryNeutral↗ source
  • Laub’s Feeding & Cubing voluntarily recalls 89 tons of mini hay cubes over botulism risk
    Laub’s Feeding & Cubing, Inc. of Beryl, Utah announced a voluntary recall of its Grade A Mini Hay Cubes. The recall covers up to 89 tons of product sold between Oct 3 and Oct 31, 2026 after the co…
    fda recalls · 1d agoCRLNegative↗ source
  • Experts urge pharma firms to build regulatory intelligence before laws take effect
    Regulatory specialists advise companies not to wait for legislation to be finalized before creating a regulatory intelligence framework. They argue that early preparation helps firms stay ahead of…
    raps · 1d agoRegulatoryNeutral↗ source