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3,117 stories matching this filter · ← front page

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  • Alumis' lupus trial misses endpoints, but company eyes phase 3 in IFNGS‑high subgroup
    Alumis reported that its phase 2b study of the TYK2 inhibitor envudeucitinib failed to meet both the primary and secondary efficacy endpoints in patients with moderate to severe systemic lupus eryt…
    Fierce Biotech · 11d agoNegative readoutNegative↗ source
  • Novocure cyberattack exposes data of over 1,400 U.S. patients and staff
    Novocure disclosed a cyberattack in an SEC filing, saying unauthorized access to some information systems was discovered in mid‑August. The breach exposed internal patient ID numbers for more than…
    Fierce Biotech · 11d agoNegative↗ source
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  • Opinion: Trump administration’s paperwork surge hampers science and health care
    The opinion piece argues that the Trump administration has expanded paperwork requirements, making it harder for scientists and Medicaid recipients to access services. Citing a federal estimate th…
    STAT · 11d agoNegative↗ source
  • ARCH Venture Partners aims to raise $3 billion for its 14th biotech fund
    ARCH Venture Partners, a leading biotech venture capital firm, announced its intention to raise about $3 billion for a new fund. The proposed fund would be the firm's 14th and would rank among the…
    Endpoints · 11d agoDealNeutral↗ source
  • FDA releases draft guidance on evaluating drug behavior in patients with liver impairment
    The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…
    raps · 11d agoRegulatoryNeutral↗ source
  • FDA urges validation of digital health endpoints and clear missing-data plans
    FDA officials highlighted key practices for sponsors using digitally derived endpoints from digital health technologies. They said endpoints must be validated for the specific patient population t…
    raps · 11d agoRegulatoryNeutral↗ source
  • Alumis' TYK2 lupus drug fails mid-stage trial, CEO says clear path forward
    Alumis announced that its TYK2 inhibitor did not meet primary endpoints in a mid-stage study in patients with lupus. The trial, which was the company's lead program, was designed to evaluate effic…
    Endpoints · 10d agoNegative readoutNegative↗ source
  • Trump unveils pricing agreements with midsize biotech firms; Novartis halts CAR-T trial after patient deaths
    The White House announced that President Trump has struck new pricing agreements with a group of midsize biotechnology companies, aiming to adjust drug costs. Novartis disclosed that it is pausing…
    raps · 11d agoDealNeutral↗ source
  • House passes stopgap bill to block White House plan for political control of federal research grants
    The House approved a temporary funding measure that blocks a White House proposal to let political appointees oversee federal research grants. The measure passed 370‑48 and mirrors a Senate bill p…
    STAT · 10d agoRegulatoryNeutral↗ source
  • Absci CEO envisions AI-driven, consumer-focused drug platform, eyeing hair loss, endometriosis and future GLP-1 combos
    Absci, an AI‑focused biotech founded about 15 years ago in Vancouver, Washington, is led by CEO Sean McClain, who likens his ambition for the company to creating the Apple of biotech. The surge in…
    Fierce Biotech · 10d agoPositive↗ source
  • K Health plans IPO by 2029 after recent funding round
    K Health, a virtual‑care company that uses AI, announced its intention to go public by 2029. CEO Allon Bloch made the comment after a recent fundraising round, signalling the firm is preparing for…
    Endpoints · 10d agoPositive↗ source
  • Arsenal Biosciences cuts 99 jobs as it pivots to in vivo CAR-T therapy
    Arsenal Biosciences announced another round of layoffs, eliminating 99 positions, which represents the majority of its workforce after a prior 50% reduction last year. The cuts are part of a strat…
    BioSpace · 11d agoLayoffsNegative↗ source
  • Trump announces voluntary pricing agreements with nine new drug makers
    President Donald Trump hosted a drug pricing event on Monday, joined by executives from several pharmaceutical companies and senior health officials. At the meeting he announced voluntary pricing…
    Endpoints · 10d agoRegulatoryNeutral↗ source
  • Arsenal Biosciences trims most of its workforce as it shifts focus to in vivo CAR T therapy
    Arsenal Biosciences announced another round of staff reductions, letting go of the majority of its employees. This follows a previous reduction about a year ago that cut roughly half of its workfo…
    Endpoints · 10d agoLayoffsNegative↗ source
  • NIH proposes cap on individual research grants, drawing mixed reactions
    The National Institutes of Health has floated a plan to limit the number of active research grants any single scientist can hold. The proposal is part of the agency’s effort to balance its research…
    STAT · 11d agoRegulatoryNeutral↗ source
  • Medline recalls neonatal and infant heated wire breathing circuits over connector failures
    Medline has issued a recall for specific neonatal and infant heated wire breathing circuits after identifying failures in the electrical connector. The FDA has classified the issue as potentially…
    fda medwatch · 11d agoCRLNegative↗ source
  • ADA internal review rejects claims of silencing protest after member expulsions
    An internal review by the American Diabetes Association examined the removal of five participants from its scientific sessions in New Orleans. The expulsions occurred after the individuals distribu…
    STAT · 10d agoNeutral↗ source
  • ADA reviews June conference disruptions, finds no censorship of editorial
    American Diabetes Association CEO Charles "Chuck" Henderson apologized after several attendees were removed from the June 5 Scientific Sessions in New Orleans for repeated disruptions. He said the…
    STAT · 10d agoNeutral↗ source
  • Google Gemini adds Zocdoc booking, while Solv partners with Amazon
    In August, Google revealed that users of its Gemini AI platform can schedule medical appointments directly through Zocdoc, integrating AI assistance with healthcare scheduling. The move expands Ge…
    Endpoints · 10d agoDealPositive↗ source
  • Trial over Lindsay Clancy’s case threatens progress in postpartum psychiatry
    Opinion piece by reproductive psychiatrist Jennifer Okwerekwu notes that the ongoing Lindsay Clancy trial, in which a jury remains deadlocked after five weeks, pits a defense claim of health-care s…
    STAT · 10d agoNegative↗ source
  • Dietitian Shortage Threatens Trump Administration's Nutrition Initiatives
    The Trump administration's Make America Healthy Again (MAHA) plan has shifted nutrition guidance, promoting more protein, cutting processed foods, and revamping meals in schools, military bases and…
    STAT · 11d agoNegative↗ source
  • Biomarin nabs big royalties in achondroplasia patent settlement with Ascendis
    Biomarin has granted Ascendis a non-exclusive, worldwide license to use navepegritide, the active ingredient in the latter company’s recently approved achondroplasia drug Yuviwel, in exchange for 1…
    BioSpace · 11d agoApprovalPositive↗ source
  • Takeda and Protagonist Therapeutics receive FDA approval for rusfertide (Mimrylo) to treat polycythemia vera
    The FDA approved rusfertide, to be sold as Mimrylo, for the treatment of polycythemia vera, a rare blood cancer, marking a key win for Takeda and its partner Protagonist Therapeutics. The decision…
    BioSpace · 12d agoApprovalPositive↗ source
  • Eli Lilly to acquire Merida Biosciences for up to $2.88 billion, adding autoimmune antibody-degrading pipeline
    Eli Lilly announced a transaction to purchase Merida Biosciences for up to $2.875 billion, combining an upfront cash payment with future milestone payments. Merida, which emerged from stealth last…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Eli Lilly to acquire Merida Biosciences for up to $2.875 billion, bolstering its immunology pipeline
    Eli Lilly announced a deal to purchase Merida Biosciences, a biotech focused on immunology, for a total consideration that could reach $2.875 billion. The acquisition adds Merida's assets in fast-…
    Endpoints · 11d agoDealPositive↗ source