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  • FDA and UK regulators discuss new frameworks for generative AI oversight
    At the MedTech Conference in Boston, officials from the U.S. Food and Drug Administration and the U.K. Medicines and Healthcare products Regulatory Agency met to talk about how to regulate generati…
    raps · 1d agoRegulatoryNeutral↗ source
  • SCRS unveils Eagle Insights Dashboard to benchmark clinical trial site performance
    The Society for Clinical Research Sites introduced a new data intelligence platform called the Eagle Insights Dashboard. The tool provides sponsors and contract research organizations with a compos…
    Fierce Biotech · 1d agoPositive↗ 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 · 2d agoDealPositive↗ source
  • Roche signs up to $15 billion ADC partnership with China's Hansoh, paying $400 million upfront
    Roche announced a new partnership with Chinese drugmaker Hansoh Pharmaceutical Group focused on antibody‑drug conjugates. The agreement includes an upfront payment of $400 million and the potential…
    BioPharma Dive · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 2d agoPositive readoutPositive↗ 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 · 2d agoDealPositive↗ source
  • 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 · 1d agoPositive readoutPositive↗ 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 · 2d 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 · 2d 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 · 2d 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 · 1d agoDealPositive↗ 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 · 2d agoNegative readoutNegative↗ 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 · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 2d agoPositive↗ 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 · 2d 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 · 1d 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 · 2d 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 · 2d agoPositive readoutPositive↗ source
  • TriGemX Bio to go public via SPAC to advance migraine drug candidate
    TriGemX Bio, formerly known as Kallyope, said it will become a public company by merging with a special purpose acquisition company. The transaction is aimed at raising capital and accelerating the…
    Endpoints · 2d agoDealNeutral↗ source