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1,429 stories matching this filter · ← front page

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  • 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
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  • 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
  • GSK secures FDA approval for lung-cancer drug Jideytro after $10.6 billion Nuvalent acquisition
    GSK received FDA clearance for Jideytro, a therapy for patients with metastatic non‑small cell lung cancer that have ROS1 gene alterations and have already been treated with another targeted drug.…
    BioPharma Dive · 22d agoApprovalPositive↗ 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
  • Arrowhead’s plozasiran cuts triglycerides up to 81% in late-stage trials, shows promise for severe hypertriglyceridemia
    Arrowhead Pharmaceuticals reported positive data from two late-stage studies of its RNA-based drug plozasiran in adults with severe hypertriglyceridemia. The trials used a subcutaneous injection e…
    BioPharma Dive · 22d agoPositive readoutPositive↗ source
  • AstraZeneca’s rare disease drug Wainua fails Phase 3, narrowing path to $80 billion sales goal
    AstraZeneca announced that its rare disease therapy Wainua did not meet its primary endpoints in a Phase 3 trial, ending plans to broaden the drug’s label for transthyretin amyloidosis cardiomyopat…
    BioSpace · 23d agoNegative readoutNegative↗ 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 · 23d agoRegulatoryNegative↗ source
  • Repligen to acquire BioLife Solutions for $1.5 billion, boosting its role in cell therapy preservation
    Repligen announced a $1.5 billion acquisition of BioLife Solutions, a company whose CryoStor media is used to preserve cell therapies during storage and transport. BioLife’s products are employed…
    BioSpace · 22d agoDealPositive↗ source
  • Crystalys Therapeutics raises $130M Series B to advance gout drug dotinurad toward global launch
    Crystalys Therapeutics announced a $130 million Series B financing to move its gout drug dotinurad through late-stage trials and prepare for commercial launch. The round was led by Frazier Life Sc…
    BioPharma Dive · 22d agoDealPositive↗ source
  • Eli Lilly’s $3.8 billion acquisition of AtaiBeckley signals strong backing for psychedelic therapeutics
    Novartis and Roche kicked off the second‑quarter earnings season, with other majors such as AstraZeneca, GSK and Biogen slated to follow. The earnings wave highlights continued revenue growth acros…
    BioSpace · 22d agoDealPositive↗ source
  • Vertex's $10 billion Crinetics buyout draws investor doubts over premium price
    Vertex was the lone bidder in a planned $10 billion acquisition of Crinetics Pharmaceuticals, a California company that focuses on endocrine medicines. Crinetics currently markets a therapy for a…
    BioPharma Dive · 22d agoDealNegative↗ source
  • Trump threatens 200% tariffs on imported generic drugs to force U.S. production
    President Trump announced on Truth Social that generic drugs imported into the United States could face a 100% tariff starting Aug. 1, 2028, rising to 200% three years later. He framed the measure…
    BioPharma Dive · 22d agoRegulatoryNegative↗ source
  • Arrowhead reports Phase 3 data showing potentially best-in-class triglyceride reduction, eyes FDA filing
    Arrowhead Pharmaceuticals announced topline results from two late-stage Phase 3 trials (SHASTA-3 and SHASTA-4) of its siRNA drug plozasiran in patients with severe hypertriglyceridemia (sHTG). Th…
    BioSpace · 22d agoPositive readoutPositive↗ 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
  • Congressional panel warns US rare-disease lead is eroding and calls for supportive policies
    A Congressional advisory panel has urged the U.S. government to adopt policies that would help rare disease drug development, including a finalized FDA platform designation and the use of novel tri…
    BioSpace · 22d agoNegative↗ 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
  • 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
  • AI data emerges as a key hurdle in biopharma partnership deals
    As drug discovery becomes more intricate, the data used to train AI models is turning into a valuable asset in biopharma transactions. Companies are now negotiating not just drug candidates but the…
    BioSpace · 23d agoDealNegative↗ 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