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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 · 5h 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 · 4h agoNegative↗ source
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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 · 6h agoLayoffsNegative↗ source
  • Early Alert: Cardinal Health Issues Correction for Presource Packs Containing BD Alaris Pump Infusion Sets
    Cardinal Health Presource Kits containing recalled BD Alaris Pump Infusion Sets should be corrected prior to continued use.
    fda medwatch · 15h ago↗ source
  • Roche signs $15 billion ADC partnership with China's Hansoh, offering $400 million upfront
    Roche announced a licensing agreement with Hansoh Pharmaceutical to develop a broad portfolio of antibody-drug conjugates (ADCs).\n\nThe deal includes an upfront cash payment of $400 million and a…
    BioSpace · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d agoApprovalPositive↗ source
  • Sanofi breaks ground on Frankfurt insulin API plant with €400 million German aid
    Sanofi has started construction of a new insulin active pharmaceutical ingredient (API) manufacturing facility at its Frankfurt site in Germany. The plant, covering about 36,000 square meters, is…
    BioSpace · 1d agoDealPositive↗ source
  • Merck KGaA to acquire Silence Therapeutics for $1.1 billion, gaining Phase 3 PV siRNA asset
    Merck KGaA announced it will buy Silence Therapeutics for about $1.1 billion, giving the German group a foothold in hematology. Silence, a UK-based RNA specialist, develops short interfering RNA m…
    BioSpace · 1d agoDealPositive↗ source
  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic protoporphyria, setting stage for FDA resubmission
    Disc Medicine's bitopertin, being developed for erythropoietic protoporphyria (EPP), a rare blood disorder that causes painful light sensitivity, had its accelerated FDA application rejected in Feb…
    BioSpace · 1d 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 · 1d 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 · 1d agoPositive readoutPositive↗ source
  • Merck acquires Silence Therapeutics for $1.3B; Hansoh Pharma signs $15B deal with Roche
    German Merck announced the acquisition of Silence Therapeutics in a transaction valued at $1.3 billion. In China, Hansoh Pharma disclosed a partnership with Roche that involves a $15 billion drug…
    raps · 1d agoDealNeutral↗ 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 · 1d agoRegulatoryNeutral↗ source
  • EyePoint cuts half its staff and ends wet AMD trials after second Phase 3 failure, pivots to diabetic macular edema
    EyePoint said it is launching a strategic review after its investigational drug duravyu failed another Phase 3 study in wet age‑related macular degeneration. The company reported that the top‑line…
    BioSpace · 1d agoLayoffsNegative↗ 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 · 1d 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 · 1d agoRegulatoryNeutral↗ source
  • Veradermics reports Phase 3 minoxidil pill boosts hair coverage in men
    After a February IPO that raised more than $256 million and a strong share rally, Connecticut‑based Veradermics now has late‑stage data for its oral minoxidil candidate. In the Phase 3 Study 304,…
    BioSpace · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d agoNeutral↗ source