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  • 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
  • Merck KGaA to acquire Silence Therapeutics for $1.3 billion, adding Phase-2 RNAi drug for polycythemia vera
    Merck KGaA announced it will purchase UK‑based Silence Therapeutics for about $1.3 billion, paying $20 in cash per share, representing a 130 % premium. The deal gives Merck control of an RNA‑inter…
    BioPharma Dive · 22d agoDealPositive
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  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic porphyria
    Disc Medicine announced that its experimental therapy bitopertin achieved its primary and secondary goals in a Phase 3 trial for erythropoietic porphyria, a rare condition that makes patients extre…
    BioPharma Dive · 22d agoPositive readoutPositive↗ 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
  • 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 · 22d agoDealNeutral↗ 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
  • Saudi Arabia rolls out biotech partnerships to support its $34.6 billion non‑oil growth plan
    Saudi Arabia’s National Biotechnology Strategy, launched in early 2024, aims to add $34.6 billion to non‑oil GDP by 2040 and create 11,000 jobs by 2030. The plan is now moving beyond policy into co…
    BioPharma Dive · 22d agoPositive↗ 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
  • ESMO 2026 preview spotlights upcoming abstracts from Zai Lab, GSK and Merck
    The European Society for Medical Oncology (ESMO) meeting returns to Madrid in 2026, featuring a slate of abstracts expected from several major biotech and pharmaceutical companies. Among the antic…
    Endpoints · 22d agoNeutral↗ source
  • Sanofi partners with ScionxBio to screen long-acting RNA candidates
    Sanofi has entered into a collaboration with biotech startup ScionxBio to evaluate long-acting RNA candidates. The agreement marks ScionxBio's first partnership since it separated from its former…
    Endpoints · 22d agoDealPositive↗ source
  • Veradermics' oral minoxidil clears late-stage trial endpoints
    Veradermics, a Connecticut‑based biotech, reported that its oral extended‑release formulation of minoxidil, VDPHL01, has completed a late‑stage clinical trial. The drug is a pill version of the wel…
    Endpoints · 22d agoPositive readoutPositive↗ source