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  • 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 · 22d agoDealPositive↗ 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
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  • 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 · 22d 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 · 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
  • 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 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 · 22d 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 · 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
  • 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 · 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
  • Merck/Moderna vaccine and Summit/Akeso bispecific therapy among key highlights at ESMO 2026
    The European Society of Medical Oncology (ESMO) meeting in Madrid this weekend will showcase several high‑profile oncology programs. Among the most watched are Merck and Moderna’s personalized can…
    BioSpace · 22d agoNeutral↗ source
  • Multispecific drug design faces growing complexity as more binding arms increase molecular options
    The industry is seeing a rapid rise in complex biologic formats such as trispecific antibodies and cell-engaging molecules. As these multispecific constructs multiply, drug developers are turning t…
    BioSpace · 22d agoNeutral↗ source
  • China proposes ban on biotech platform sales but keeps licensing deals open
    Chinese ministries of Commerce and Science and Technology released a draft policy that would prohibit the transfer of ownership for five biotech technologies, including cell and gene therapy, small…
    BioSpace · 22d agoRegulatoryNeutral↗ source
  • Enlivex cuts 60% of staff, halts preclinical R&D and slashes exec salaries to fund osteoarthritis trial
    Enlivex, an Israeli biotech developing a cell‑based immunotherapy called allocetra for knee osteoarthritis, announced today that it is reducing its workforce by 60 percent. The cut reduces the sta…
    Fierce Biotech · 22d agoLayoffsNegative↗ source
  • Merck KGaA buys Silence in $1.3B deal after siRNA drug's phase 2 blood cancer win
    Germany’s Merck KGaA has picked up Silence Therapeutics to the tune of $1.3 billion in the wake of the British biotech’s mid-stage success for its challenger to Takeda’s Mimrylo.
    Fierce Biotech · 22d agoDealNeutral↗ source
  • Immunology Society Split Over California’s $8.4 B Proposition 38 Funding Measure
    Internal emails obtained by STAT reveal a sharp split within the American Association of Immunologists over California’s Proposition 38, a ballot measure that would direct $8.4 billion of taxpayer…
    STAT · 22d agoNeutral↗ source
  • Experts tout amylin as promising, potentially gentler obesity target as new combo therapies near FDA review
    While GLP-1 medicines dominate the weight‑loss market, some observers argue that amylin would have been the logical primary target for obesity treatment a decade ago. Novo Nordisk’s amylin/GLP‑1 c…
    BioSpace · 22d agoPositive↗ source
  • Arbitrators profit heavily from No Surprises Act disputes, raising concerns over health-care billing practices
    The STAT Health Care Inc. newsletter reports that the arbitration mechanism created by the No Surprises Act, intended to resolve out-of-network billing conflicts, has become a lucrative business fo…
    STAT · 22d agoNegative↗ source