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2,182 stories matching this filter · ← front page

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  • European pharma CEOs warn of biotech decline as R&D share drops to 31% and call for faster trials and stronger IP protection
    Nine leading European pharma board chairs issued an open letter warning that Europe is losing its biotech edge. They note that Europe's share of global pharma R&D fell from 43% in 1990 to 31% toda…
    BioPharma Dive · 1mo agoNegative↗ source
  • FDA panel questions effectiveness of Grail's early-cancer detection test
    FDA's Molecular and Clinical Genetics Panel and agency officials raised concerns about Grail's next-generation sequencing test designed to detect multiple cancers early in adults over 50. The advi…
    Endpoints · 1mo agoRegulatoryNegative↗ source
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  • World's first personalized gene-editing therapy costs $1.65 million per patient, project director says
    At a rare disease conference in Oxford, Fyodor Urnov disclosed that the world's first therapy designed to correct an individual’s unique genetic mutation cost $1.65 million to produce. The treatme…
    Endpoints · 1mo agoNeutral↗ source
  • FDA issues early alert on React Health VOCSN ventilators over connector fault
    The FDA's Center for Devices and Radiological Health has posted an early alert about a potential high‑risk problem with certain VOCSN ventilator units made by Ventec Life Systems, operating as Reac…
    fda medwatch · 1mo agoRegulatoryNeutral↗ source
  • AI-driven biotech Enveda secures $311 million Series E to advance plant-derived drug candidates
    Enveda Biosciences, a Colorado AI drug discovery company, announced a $311 million Series E financing round, one of the larger biotech raises this year. The firm uses artificial intelligence to sc…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Former Changsheng biotech chair sentenced to life in prison over Chinese rabies vaccine scandal
    Chinese authorities sentenced Gao Junfang, the former chairwoman of Changsheng Biotechnology, to life imprisonment after a court found her guilty of wrongdoing in a rabies vaccine scandal. The cas…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Enveda secures $311 million in third consecutive megaround to advance discovery and weight-maintenance programs
    Enveda, a biotech startup operating out of Colorado and India, announced a new financing round on September 23, 2026. The company raised $311 million, marking its third large-scale funding round i…
    Endpoints · 1mo agoDealPositive↗ source
  • AI startup Basecamp Research secures $140 million Series C funding and outlines six-program AI pipeline
    Basecamp Research, an AI-driven biotech founded in 2019, announced a $140 million Series C financing round. The company said the new capital will support its ambitious six-program pipeline that ap…
    Endpoints · 1mo agoDealPositive↗ source
  • Roche reports positive interim Phase 3 results for kidney drug, paving way for accelerated approval
    Roche announced interim results from its Phase 3 trial of a kidney disease therapy, indicating the study met its primary endpoints. The data, released on Wednesday, suggest the drug could qualify…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • FDA issues early alert on Abiomed Impella controller safety issue
    The FDA Center for Devices and Radiological Health (CDRH) has posted an Early Alert about a potential high risk problem with certain Abiomed Impella automated controllers. Abiomed has sent a lette…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Roivant's FcRn drug IMVT-1402 fails Phase 2b lupus trial
    Roivant announced that its FcRn-targeting antibody IMVT-1402 (imeroprubart) failed to meet primary endpoints in a Phase 2b trial in patients with lupus. The study did not show improvement in disea…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Family’s struggle to receive cystic fibrosis medication highlights care gaps
    Stephanie Marquart in Knoxville, Tennessee, waited anxiously for a delivery to her home, refreshing the tracking page repeatedly as the package made its way to her doorstep. The episode, described…
    Endpoints · 1mo agoNegative↗ source
  • Amgen reports positive Phase 3 results for Sjögren's drug; Novartis announces $900M radioligand partnership
    Amgen said its CD40 ligand antagonist dazodalibep met the primary endpoint in a Phase 3 trial for Sjögren's syndrome, marking a notable achievement for the company. Novartis disclosed a $900 milli…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Amgen's Dazodalibep Shows Positive Results in First Phase 3 Trial for Sjögren’s Syndrome
    Amgen announced that its experimental drug dazodalibep, acquired through the Horizon Therapeutics acquisition, met the primary endpoint in the first of two Phase 3 trials for Sjögren’s syndrome, a…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Celldex shares drop as Phase 3 data for barzolvolimab show efficacy but raise anaphylaxis safety concerns
    Celldex reported Phase 3 results for barzolvolimab in chronic spontaneous urticaria, showing strong efficacy against hives and itching. Two cases of life-threatening anaphylaxis were observed amon…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Alkermes reports early proof-of-concept for orexin-2 drug in ADHD
    Alkermes announced early-stage trial results for ALKS 7290, an orexin‑2 receptor agonist originally being developed for narcolepsy, showing proof of concept in ADHD. The study reported dose‑depend…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • US officials launch probe into falling German drug prices amid EU pharma push for competitiveness
    US trade officials held a hearing on Tuesday about a possible investigation into the decline in Germany's payments for pharmaceuticals. Testimony presented arguments both supporting and opposing t…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Vertex reports early kidney drug data, boosting hopes for broad label ahead of next year's pivotal readout
    Vertex Pharmaceuticals disclosed early data from its experimental kidney disease therapy inaxaplin, showing improvements on a urine-based biomarker. The drug demonstrated positive changes in two s…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Viking Therapeutics reports obesity drug maintains weight loss after dosing switch, shares jump 36%
    Viking Therapeutics said its Phase 2 trial of the dual-acting obesity candidate VK2735 showed participants largely kept the weight they had lost when the dosing schedule changed from a weekly injec…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Celldex's barzolvolimab meets Phase 3 goals but safety concerns emerge
    Celldex announced that its experimental chronic hives treatment, barzolvolimab, achieved the primary endpoint in two Phase 3 trials. The trials demonstrated the drug's efficacy in reducing hive sy…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • Nvidia-backed Iambic Therapeutics files for IPO, unveils AI-driven pipeline
    Iambic Therapeutics, a San Diego biotech that uses artificial intelligence to discover medicines, announced it has filed a registration statement to become a publicly traded company. The filing ma…
    Endpoints · 1mo agoDealNeutral↗ source
  • Trump administration’s MFN drug pricing deals may cut projected Medicare savings by up to 80%
    The White House announced "most-favored-nation" pricing agreements with 26 pharmaceutical companies, saying the contracts would lower drug costs for federal programs. The deals require companies to…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Roche presents positive Phase 2 results for enicepatide in overweight and obese type 2 diabetes patients
    Roche has released new data from a Phase 2 trial of enicepatide, a peptide acquired from Carmot Therapeutics, focusing on overweight or obese adults with type 2 diabetes. The trial met its primary…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • FDA issues third warning letter to Empower Pharmacy over GLP-1 weight-loss treatments
    The U.S. Food and Drug Administration sent a formal warning letter to Empower Pharmacy, a compounder based in Houston, concerning its GLP-1 weight-loss products. The notice marks the company's thi…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Federal AI Initiative Aims to Improve Chronic Heart Failure Care, Pending Doctor and Patient Acceptance
    A new federal program will test artificial‑intelligence tools in the management of chronic heart‑failure patients. The initiative is designed to explore how AI can support diagnosis, monitoring and…
    Endpoints · 1mo agoNeutral↗ source