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  • JAMA paper on OpenEvidence highlights clinician use but raises unanswered questions
    A new study published in JAMA examines how clinicians are employing the OpenEvidence platform, an artificial-intelligence-driven tool designed to assist medical decision-making. The authors highli…
    STAT · 21d agoNeutral↗ source
  • Reporter urges audiences to skip new Elizabeth Holmes documentary
    Matthew Herper, a reporter covering medical innovation, recounts his two interviews with Elizabeth Holmes in 2015, at the peak of Theranos hype. The first interview occurred just before John Carre…
    STAT · 21d agoNegative↗ source
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Merck KGaA to acquire Silence Therapeutics for $1.3 billion, expanding siRNA portfolio
Merck KGaA, the German science and technology conglomerate, announced an agreement to purchase UK‑based Silence Therapeutics. The deal is valued at about $1.3 billion and gives Merck access to Sil…
Endpoints · 22d agoDealPositive↗ source
  • Roche signs $400 million upfront deal with China's Hansoh, potential $15 billion partnership
    Roche announced a major collaboration with Chinese biotech Hansoh, committing $400 million upfront. The agreement gives Roche access to Hansoh's drug discovery platform and aims to co-develop cand…
    Endpoints · 22d agoDealPositive↗ source
  • Disc spins past FDA rejection with ‘overwhelmingly positive’ phase 3 data for rare disease drug
    A phase 3 trial of Disc Medicine’s bitopertin has hit both co-primary endpoints and all secondary endpoints, positioning the biotech to refile for approval of the once-rejected rare disease drug ca…
    Fierce Biotech · 22d agoApprovalPositive↗ source
  • Roche signs $15 billion ADC partnership with China's Hansoh Pharma
    Roche has re-entered a partnership with China's Hansoh Pharmaceutical, signing a $15 billion biobucks agreement. The deal covers a broad portfolio of antibody-drug conjugate programs, including tw…
    Fierce Biotech · 22d agoDealPositive↗ source
  • Israeli biotech's inhaled exosome therapy cuts respiratory failure and mortality in ARDS phase 2b trial
    Nano24, an Israeli biotech company, tested its inhaled exosome product EXO‑CD24 in a mid‑stage study involving 90 patients with acute respiratory distress syndrome. The trial compared the therapy,…
    Fierce Biotech · 22d agoPositive readoutPositive↗ source
  • FDA Grants Accelerated Approval for Jemperli Immunotherapy in Locally Advanced Rectal Cancer
    The U.S. Food and Drug Administration has granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab‑gxly). The approval applies to adults with previously untreated stage…
    fda press · 22d agoApprovalPositive↗ source
  • Pathos AI partners with BMS and Tempus to use AI for Alzheimer’s drug development
    Pathos AI announced two collaborations aimed at accelerating drug development for neurological disorders, including Alzheimer’s disease. The agreement with Bristol Myers Squibb gives the pharma co…
    Fierce Biotech · 22d agoDealPositive↗ source
  • Gilead to launch Phase 3 trial of oral α4β7 inhibitor after promising Phase 2 ulcerative colitis results
    Gilead Sciences announced plans to begin Phase 3 trials next year for its oral α4β7 integrin inhibitor aimed at treating ulcerative colitis. The move follows a Phase 2 dose‑finding study that repo…
    Endpoints · 22d agoPositive readoutPositive↗ source
  • Gilead’s oral ulcerative colitis drug shows significant remission in Phase 2 trial
    Gilead Sciences reported results from a Phase 2 trial of its oral ulcerative colitis drug emvistegrast. In the study, patients took a 200 mg daily dose for 12 weeks and achieved a 23% placebo-adju…
    STAT · 22d agoPositive readoutPositive↗ source
  • AbbVie’s combo of Skyrizi and trosunilimab shows higher remission than Skyrizi alone in phase 2 Crohn’s trial
    AbbVie tested a next‑generation Crohn’s disease regimen by randomizing 300 patients with moderate‑to‑severe disease to receive Skyrizi, the α4β7 inhibitor trosunilimab, or the two drugs together (c…
    Fierce Biotech · 22d agoPositive readoutPositive↗ source
  • Lilly reports 79% response rate for FRα-directed ADC in platinum-sensitive ovarian cancer
    Lilly presented phase 1 data on its FRα‑directed antibody‑drug conjugate, sofetabart mipitecan (Sofe-M), combined with bevacizumab in patients whose ovarian cancer had progressed after platinum the…
    Fierce Biotech · 22d agoPositive readoutPositive↗ source
  • Antheia secures $80 million conditional loan from DOD to expand U.S. generic drug manufacturing
    Antheia, a biosynthesis manufacturer, has been awarded a conditional loan of $80 million from the U.S. Department of Defense. The funding is aimed at onshoring the company’s generic drug productio…
    Endpoints · 22d agoDealPositive↗ source
  • Trump signs executive order to create NIH division and White House task force for women’s health
    President Donald Trump signed an executive order on Monday establishing a new division within the National Institutes of Health and a White House task force focused on women’s health. The order dir…
    STAT · 22d agoRegulatoryNeutral↗ source
  • EyePoint's Phase 3 trial fails, prompting 53% staff cuts; Lilly signs China drug delivery partnership
    EyePoint, a Watertown, Massachusetts biotech, reported that its experimental therapy did not meet primary endpoints in a Phase 3 study, marking a setback for the company. Following the trial failu…
    Endpoints · 22d agoNegative readoutNegative↗ source
  • China proposes new limits on foreign biotech acquisitions to protect domestic drug development
    China is drafting new rules that would restrict foreign companies from acquiring Chinese biotech assets deemed critical to the nation's drug development sector. The proposal aims to keep control o…
    STAT · 22d agoRegulatoryNeutral↗ source
  • FDA forms new board to guide drug exclusivity decisions as Roche reexamines German investments
    The U.S. Food and Drug Administration's Center for Drug Evaluation and Research has created a board to oversee and advise on drug exclusivity decisions. Reuters reports the board is intended to imp…
    STAT · 22d agoRegulatoryNeutral↗ source
  • Disc Medicine's rare sun-sensitivity drug meets all endpoints in Phase 3 trial
    Disc Medicine announced that its experimental therapy for a rare condition that makes sun exposure painful has completed a Phase 3 study. The trial reported success on every primary and secondary…
    Endpoints · 22d agoPositive readoutPositive↗ source
  • Eli Lilly teams with Hong Kong's Metis TechBio in up to $1.1 billion AI nanoparticle partnership
    Eli Lilly has entered a partnership with Hong Kong‑based Metis TechBio to access an artificial‑intelligence driven platform for designing lipid nanoparticles that can improve drug delivery. The co…
    Fierce Biotech · 22d agoDealPositive↗ source
  • TCGX uses SPAC to take migraine biotech TriGemX public, securing $246M for phase-3 trial
    TCGX, a life‑sciences investment firm, announced it will merge its SPAC with TriGemX Bio, a biotech focused on migraine treatments. TriGemX, formerly known as Kallyope, is developing a TRPM8 chann…
    Fierce Biotech · 22d agoDealPositive↗ source
  • Gilead reports positive Phase 2 results for oral ulcerative colitis drug
    Gilead announced that its experimental oral therapy for ulcerative colitis achieved positive results in a Phase 2 trial. The study reported that patients receiving the drug showed measurable clini…
    Fierce Biotech · 22d agoPositive readoutPositive↗ source
  • Nonprofit arbitrators under No Surprises Act earning large profits, investigation finds
    A recent STAT investigation examined the role of nonprofit organizations that serve as arbitrators under the No Surprises Act. The report found that these entities are generating substantial revenu…
    STAT · 22d agoRegulatoryNegative↗ source
  • Alphabet’s Isomorphic Labs draws VC interest as it seeks to turn AI protein modeling into drug discovery engine
    Isomorphic Labs, an Alphabet spin‑off, is building a platform that uses its protein‑modeling AI to create new medicines. The secretive startup has not been actively raising money, but venture firm…
    STAT · 22d agoNeutral↗ source
  • Nouscom secures $135 million Series D to advance lead cancer vaccine into Phase 2
    Clinical-stage biotech Nouscom announced it has closed a $135 million Series D financing round that was oversubscribed. The capital will be used to move its lead cancer vaccine candidate into a Pha…
    Endpoints · 22d agoDealPositive↗ source