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  • Roche Diagnostics sales rise only 3% in H1 2026 as China pricing reforms weigh
    Roche Diagnostics reported sales of 6.73 billion Swiss francs for the first half of 2026, a 3% increase at constant exchange rates but a 3% decline in reported franc terms. Growth was limited by p…
    Fierce Biotech · 21d agoEarningsNegative↗ source
  • Clinuvel to relocate HQ to US and cut up to 20% of staff
    Clinuvel Pharmaceuticals, an Australian biotech, announced it will move its corporate headquarters to the United States starting Jan 1, 2027. The company said the shift is aimed at attracting U.S.…
    Fierce Biotech · 21d agoLayoffsNegative↗ source
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  • J&J gets FDA clearance for general surgery robot; study finds 90% of approved drugs meet post-marketing commitments
    J&J received FDA authorization for a general‑surgery robot, a notable regulatory step for the company. The FDA is also being urged to ban direct‑to‑consumer drug advertisements, highlighting ongoi…
    raps · 21d agoRegulatoryNeutral↗ source
  • EMA seeks input on draft revisions to biosimilar efficacy guidance
    The European Medicines Agency has issued a draft concept paper and is asking stakeholders for feedback on proposed revisions to its guideline for biosimilar efficacy studies. The changes are inten…
    raps · 21d agoRegulatoryNeutral↗ source
  • FDA advisory panel votes to add two peptides, BPC-157 and KPV, to 503A bulk compounding list
    The FDA’s advisory committee voted 8-6, with one abstention, to recommend that two peptides be placed on the 503A Bulks List for bulk compounding. The recommendation covers BPC-157, proposed for ul…
    raps · 21d agoRegulatoryNeutral↗ source
  • Formation Bio appoints veteran biotech leader Michael Ehlers as chief scientific officer
    Formation Bio, an AI-focused biotech, announced the hiring of Michael Ehlers, M.D., Ph.D., as its chief scientific officer and head of research and development. Ehlers brings a blend of academic a…
    Fierce Biotech · 21d agoPositive↗ source
  • Sartorius cuts revenue by €26 million to refund US Trump tariffs to customers
    Sartorius announced a reduction in its revenue by €26 million as it refunds tariffs imposed under the Trump administration to its customers. The refunds stem from a recent US Supreme Court ruling…
    Endpoints · 21d agoRegulatoryNeutral↗ source
  • FDA to discontinue pilot program aimed at preventing drug production issues
    The U.S. Food and Drug Administration announced it will end a pilot program that was created to help drug manufacturers address production problems before they arise. The initiative, which ran for…
    Endpoints · 21d agoRegulatoryNeutral↗ source
  • Chairman of Urbo Bank purchases €25,000 of bank's subordinated bonds
    Urbo bankas UAB disclosed that its Chairman of the Board, Marius Arlauskas, acquired the bank's subordinated bonds. The acquisition covered 25 bonds with a total consideration of EUR 25,000 and wa…
    globenewswire health · 21d agoRegulatoryNeutral↗ source
  • Alm. Brand A/S discloses executive share transactions per EU regulation
    Alm. Brand A/S has issued a regulatory filing that details recent trading activity in its own shares by company executives and their related parties. The disclosure is made under Article 19 of EU…
    globenewswire health · 21d agoRegulatoryNeutral↗ source
  • Urbo Bank discloses board chair’s purchase of 25 subordinated bonds for €25,000
    Urbo Bank announced that its board chairman and administration head, Marius Arlauskas, bought 25 units of the bank’s subordinated bonds (ISIN LT0000135659). The purchase, amounting to €25,000, was…
    globenewswire health · 21d agoDealNeutral↗ source
  • FDA approves Nuvalent lung cancer drug shortly after GSK completes $10.6 billion acquisition
    The FDA announced Wednesday that it has approved a lung cancer medicine from Nuvalent, marking a key regulatory milestone for the biotech. The clearance arrived just a week after GlaxoSmithKline c…
    Endpoints · 22d agoApprovalPositive↗ source
  • Trump threatens up to 200% tariffs on generic drugs not manufactured in the United States
    President Donald Trump announced that his administration will consider imposing steep tariffs on generic medicines that are imported rather than produced in the United States. The proposed tariffs…
    Endpoints · 22d agoRegulatoryNegative↗ source
  • NIH joins Trump’s $5B AI Genesis Mission to boost biomedical research
    The U.S. Department of Health and Human Services announced that the National Institutes of Health will take part in the President’s Genesis Mission, a $5 billion AI-driven effort. The initiative a…
    Fierce Biotech · 22d agoRegulatoryPositive↗ source
  • Mentari Therapeutics secures second $200M private placement to fund migraine program and advance reverse merger
    Mentari Therapeutics, a spin‑out focused on migraine treatments, announced it has arranged a second private‑placement financing of $200 million. The new capital will be used to advance its migrain…
    Endpoints · 22d agoDealPositive↗ source
  • Eli Lilly to spend $2.8 billion on AtaiBeckley acquisition as it ramps up Alzheimer’s prevention push
    Eli Lilly is signaling a renewed focus on neuroscience, emphasizing its ambition to tackle brain disorders. The company announced it will pay $2.8 billion upfront to acquire AtaiBeckley, a move in…
    Endpoints · 22d agoDealPositive↗ source
  • Crystalys Therapeutics raises $130M to launch gout drug in US and Europe
    San Diego‑based Crystalys Therapeutics announced a new $130 million Series B financing round. The capital will be used to advance its gout treatment, which already holds regulatory approval in Japa…
    Endpoints · 22d agoDealPositive↗ source
  • Summit Therapeutics shares two-year survival data for its experimental cancer drug ivonescimab in Western patients
    Summit Therapeutics presented new two-year overall survival results for its experimental antibody ivonescimab in Western participants of its global Phase 3 trial. The data were released alongside…
    Endpoints · 22d agoNeutral↗ source
  • Celldex halts development of mast cell antibody after Phase 2 failure in prurigo nodularis
    Celldex announced it will discontinue the clinical program for its mast cell‑targeting monoclonal antibody aimed at treating prurigo nodularis, a chronic itchy‑skin condition. The decision follows…
    Endpoints · 22d agoNegative readoutNegative↗ source
  • Biotech deal activity picks up in Q2 2026, signaling recovery after summer slump
    The biotech sector experienced a sharp decline in confidence last summer, leading to a slowdown in financing and partnership activity. New data show that in the second quarter of 2026, dealmaking…
    Endpoints · 22d agoDealPositive↗ source
  • House passes FDA Modernization Act 3.0 to push update of animal testing regulations
    The U.S. House approved the FDA Modernization Act 3.0, a bill aimed at modernizing preclinical testing rules. The legislation requires the FDA to revise regulations that still reference animal tes…
    Fierce Biotech · 22d agoRegulatoryPositive↗ source
  • Vertex pays second-highest M&A premium as sole bidder for Crinetics
    Vertex Pharmaceuticals emerged as the only bidder for Crinetics Pharmaceuticals, aiming to acquire the company. The bid involved a premium that ranks as the second-highest in the biopharma sector…
    Endpoints · 22d agoDealNeutral↗ source
  • Royalty Pharma pays $125M upfront for royalty stake in AstraZeneca’s ATTR drug cliramitug
    Royalty Pharma has entered a deal to acquire a royalty interest in a transthyretin amyloidosis drug being developed by AstraZeneca. The agreement involves an upfront payment of $125 million to Neu…
    Fierce Biotech · 22d agoDealPositive↗ source
  • FDA sends warning letters to Sanofi and Viatris over misleading product claims
    The FDA’s Office of Prescription Drug Promotion issued untitled warning letters to Sanofi and Viatris after reviewing promotional materials that the agency deemed misleading. The letters cite spec…
    raps · 22d agoRegulatoryNegative↗ source
  • Arrowhead's gene-silencing therapy shows strong results in two late-stage triglyceride trials
    Arrowhead Pharmaceuticals reported positive data from its lipid-lowering gene-silencing candidate Redemplo in two late-stage studies. The results suggest the therapy effectively reduces triglyceri…
    Endpoints · 22d agoPositive readoutPositive↗ source