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  • UniQure shares tumble as Huntington's gene therapy shows reduced benefit over time
    UniQure announced new follow-up data from its experimental gene therapy for Huntington's disease, indicating the treatment's effect may diminish with longer observation. The additional year of dat…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • AstraZeneca commits $2 billion to partner Summit Therapeutics on bispecific cancer antibody
    AstraZeneca has announced a $2 billion investment to work with Summit Therapeutics. The deal will fund the testing of Summit’s bispecific antibody, ivonescimab, which targets both PD‑1 and VEGF pat…
    STAT · 1mo agoDealPositive↗ source
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  • Novo to pay up to $2.6 billion for rights to Hengrui’s experimental weekly obesity pill
    Novo Pharmaceuticals has signed a licensing agreement with China's Hengrui Pharma to acquire an experimental oral weight‑loss drug that is administered once a week. Under the deal, Novo could pay…
    STAT · 1mo agoDealNeutral↗ source
  • ARCH Venture Partners and Population Health Partners launch China-based sleep-disorder startup Somnivera
    ARCH Venture Partners and Population Health Partners have teamed up again to create a new China-focused biotech, Somnivera, aimed at developing therapies for sleep disorders. The partnership follo…
    Endpoints · 1mo agoDealPositive↗ source
  • Fresenius Kabi partners with Waltz Health to sell biosimilars directly to employer health plans
    Fresenius Kabi announced it will begin selling biosimilar medicines directly to employer-sponsored health plans. The company is working with Waltz Health, a marketplace owned by Eversana, to help…
    Endpoints · 1mo agoDealPositive↗ source
  • Former Spark co-founder Steven Altschuler launches new immune-resetting biotech
    Steven Altschuler, who co-founded Spark Therapeutics, has announced the formation of a new biotech that aims to reset the immune system. The venture is positioned to address autoimmune diseases, a…
    Endpoints · 1mo agoDealPositive↗ source
  • ai3Bio raises $48 million to develop T-helper cell-targeted immune-reset therapies
    ai3Bio, a new biotech startup formed from Corner Therapeutics and Novasenta, announced it has secured $48 million in an early-stage venture capital round. The company aims to create treatments for…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Highlight Therapeutics reports positive Phase 2b results for BO-112 in high‑risk head and neck basal cell carcinoma
    Highlight Therapeutics announced that its Phase 2b study of BO-112 met the primary endpoint of visual and pathological response at week 24 in patients with localized high‑risk head and neck basal c…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • AI health startup Ortet launches with $500M backing from former Genentech AI team
    Ortet, a new health-technology company, announced its launch on Tuesday. The firm was founded by three former AI scientists and engineers who previously worked at Roche's Genentech division. Orte…
    Endpoints · 1mo agoDealPositive↗ source
  • Novo pays $300 million upfront to license Hengrui’s weekly oral GLP-1/GIP weight-loss drug
    Novo Nordisk announced a licensing agreement with Chinese drugmaker Hengrui for a preclinical weekly oral GLP-1/GIP receptor agonist aimed at weight loss. The deal involves an upfront payment of $…
    Endpoints · 1mo agoDealPositive↗ source
  • uniQure shares tumble 41% after Huntington’s gene therapy misses primary endpoint
    uniQure reported updated 48‑month data from its phase 1/2 trial of AMT‑130 in Huntington’s disease. The therapy showed a 44% slowing of disease progression on the composite Unified Huntington’s Dis…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Midterm elections could reshape drug pricing, Medicaid funding and research support, industry leaders warn
    The November midterm elections are set to influence major health-care policy debates in Washington, according to STAT+. Industry leaders say the outcome could affect Medicaid funding levels, the p…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • CMS ends automatic Medicare bonuses for FDA breakthrough devices
    CMS announced that beginning in October, devices carrying the FDA’s breakthrough designation will no longer receive automatic extra payments from Medicare. The change removes the special pathway th…
    STAT · 1mo agoRegulatoryNegative↗ source
  • MAHA Institute pushes for broader health data sharing to aid research on chronic disease and autism
    At a recent event, the Make America Healthy Again (MAHA) Institute, linked to allies of Robert F. Kennedy Jr., argued that opening health records to federal researchers could accelerate studies of…
    STAT · 1mo agoRegulatoryPositive↗ source
  • FDA approves Egetis Therapeutics' Emcitate for rare X linked disease shortening life expectancy to 35 years
    Egetis Therapeutics announced that the U.S. Food and Drug Administration has granted approval for its drug Emcitate. The therapy is intended for patients with a rare X linked genetic disorder that…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Regulators Discuss Plans to Streamline Europe’s Drug Approval Process at 2026 RAPS Convergence
    A panel of European regulators gathered at the 2026 RAPS Convergence in Charlotte, North Carolina to discuss ongoing initiatives aimed at simplifying the continent’s regulatory framework. The offi…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on requirements for robotically assisted surgical devices
    The FDA has published a draft guidance outlining its thinking on the requirements for bringing certain robotically assisted surgical devices to market. The guidance describes both non-clinical and…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Beam Therapeutics sues former scientist over alleged IP theft to launch Chinese biotech YolTech
    Beam Therapeutics, a Cambridge‑based gene‑editing company, has filed a lawsuit accusing a former scientist of stealing proprietary data. The complaint says Zi Jun "Emma" Wang accessed Beam's elect…
    STAT · 1mo agoNegative↗ source
  • SK pharmteco commits over $200 million to expand CDMO infrastructure, adding 100 jobs over five years
    SK pharmteco announced a plan to invest at least $200 million in building out its development and manufacturing infrastructure over the next five years. The funding is aimed at expanding the compa…
    Endpoints · 1mo agoPositive↗ source
  • Ontario launches $5M QuickStart program to cut clinical trial start-up time to 45 days
    Ontario’s Clinical Trials Ontario has introduced a $5 million QuickStart program that promises to reduce the time needed to launch a clinical trial to as little as 45 days. The initiative is desig…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Swedish biotech AnaCardio secures $70.9M Series B to advance heart failure drug
    Swedish biotech AnaCardio announced a Series B financing round that raised €62.5 million ($70.9 million). The capital will be used to move its chronic advanced heart failure drug toward registrati…
    Endpoints · 1mo agoDealPositive↗ source
  • BioNTech to shut three German manufacturing sites after sale talks fall through
    BioNTech announced it will close three of its manufacturing facilities in Germany. The decision follows months of searching for buyers for the sites. The company said it was unable to secure a dea…
    Endpoints · 1mo agoDealNegative↗ source
  • Biopharma layoffs ease in Q3 2026, but cuts still ongoing
    Recruiters note that biopharma layoff volume in Q3 2026 remained modest, suggesting the sector is moving past the large wave of cuts seen last year. Fierce recorded 21 layoff announcements between…
    Fierce Biotech · 1mo agoLayoffsNegative↗ source
  • MAHA Summit Shows Grassroots Health Movement Aligning with Industry Leaders
    The recent MAHA Summit brought together federal officials and health‑care executives, marking a shift from the movement’s original grassroots stance. At a panel on affordability, leaders from Unit…
    STAT · 1mo agoNegative↗ source
  • Enanta cuts 37 jobs as it pivots toward immunology and awaits key antiviral trial readouts
    Enanta Pharmaceuticals announced it is laying off 37 employees as it refocuses resources ahead of upcoming trial readouts. The company said the decision was part of a fiscal year‑end review to rig…
    Fierce Biotech · 1mo agoLayoffsNegative↗ source