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1,186 stories matching this filter · ← front page

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  • 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 · 29d 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 · 29d agoNegative readoutNegative↗ source
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  • 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 · 29d agoPositive readoutPositive↗ source
  • Novartis licenses preclinical radioligand from China's BoomRay in up to $900 million deal
    Novartis has expanded its radiopharmaceutical pipeline by signing a licensing agreement with Chinese biotech BoomRay Therapeutics. The deal could be worth up to $900 million, including an upfront…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Amgen’s Horizon-acquired drug dazodalibep meets primary endpoint in phase 3 Sjögren’s trial
    Amgen announced that its investigational fusion protein dazodalibep, acquired through Horizon Therapeutics, achieved its primary goal in a phase 3 study of patients with moderate to severe Sjögren’…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • Vertex reports positive Phase 2b results for inaxaplin in APOL1-mediated kidney disease
    Vertex Pharmaceuticals announced positive Phase 2b data for its kidney disease candidate inaxaplin, which targets APOL1-mediated kidney disease (AMKD). The Amplified trial enrolled two cohorts: 2…
    Fierce Biotech · 29d 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 · 29d agoPositive readoutPositive↗ source
  • Boston life-science lab vacancy climbs to 31% as new spaces sit empty
    Vacancy rates for laboratory and manufacturing space in Massachusetts have surged dramatically, rising from around 3% in 2021 to roughly 31% by mid-2026, according to recent data. One high-profile…
    Fierce Biotech · 29d agoNegative↗ 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 · 29d agoRegulatoryNegative↗ source
  • Siemens Healthineers partners with Novo to raise awareness and testing for fatty liver disease
    Siemens Healthineers and Novo have announced a collaboration aimed at increasing awareness and improving diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD) and its progre…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Cordis receives FDA approval for first sirolimus drug-coated balloon for coronary in-stent restenosis
    The U.S. Food and Drug Administration has approved a new device from Cordis that delivers sirolimus via a drug-coated balloon. This is the first sirolimus-eluting balloon cleared for use in treatin…
    Fierce Biotech · 29d agoApprovalPositive↗ source
  • Iambic Therapeutics eyes IPO as it pushes HER2 inhibitor IAM1363 into early trials
    Iambic Therapeutics, a San Diego AI‑driven biotech, said it is preparing for an initial public offering after securing several large‑scale partnerships with major pharmaceutical companies. In its…
    Fierce Biotech · 29d agoPositive↗ source
  • Lexeo Therapeutics acquires Mantle Therapeutics for $8.3M to expand Friedreich ataxia pipeline
    Lexeo Therapeutics announced it will acquire Mantle Therapeutics for an upfront payment of $8.3 million, aiming to broaden its Friedreich ataxia pipeline. The transaction could rise to $21.3 milli…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Anaconda Biomed snares $56M in funding for endovascular tech
    Medtech startup Anaconda Biomed has hauled in $53 million to help finish off work on a pivotal trial for its endovascular project.
    Fierce Biotech · 29d agoNeutral↗ source
  • Boehringer Ingelheim partners with Envisagenics on $1 billion AI-driven oncology collaboration
    Boehringer Ingelheim and AI drug discovery firm Envisagenics have signed a potential $1 billion multi‑year agreement to validate tumor‑specific targets. The deal will see Boehringer use Envisagenic…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Telix to acquire ITM Isotope for $1.65 billion, targeting radioligand therapy market
    Telix Pharmaceuticals announced it will acquire ITM Isotope Technologies Munich for $1.65 billion upfront, securing a radiopharmaceutical supply network. The acquisition brings an R&D pipeline cen…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • FDA issues rule to allow non-animal testing methods for drug safety
    FDA issued a direct final rule that updates its regulations to clarify that non-animal methods may be used for safety testing of drugs and biological products before they are tested in humans. The…
    fda press · 1mo agoRegulatoryPositive↗ source
  • Telix to acquire Germany's ITM for $1.65 billion, aiming to dominate radiopharmaceutical market
    Telix, an Australian radiopharmaceutical diagnostics company, announced it will purchase German developer ITM in a cash transaction valued at $1.65 billion upfront. The agreement gives Telix the o…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • White House considers executive order to politicize NIH grant approvals
    Senior officials met in the Oval Office on Friday to discuss an executive order that would establish an external panel with authority to reject NIH grant applications. The meeting, reported by The…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ source
  • Novo Nordisk faces investor skepticism at Capital Markets Day as it outlines consumer and obesity growth plans
    Novo Nordisk held its Capital Markets Day in London, where CEO Mike Doustdar acknowledged the need to reassure a restless investor audience. The company has recently streamlined its brand after a p…
    Fierce Biotech · 1mo agoNeutral↗ source
  • China aims for 25% of global first-in-class drugs by 2030 under new five-year plan
    China's government has set an ambitious target to capture at least a quarter of the world’s first‑in‑class drug discoveries by 2030. The goal is part of a five‑year plan released by the National Me…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Global Mix Inc. recalls Niwali Tejocote supplements after FDA finds toxic yellow oleander content
    Global Mix Inc., based in Middle Village, New York, announced a recall of its Niwali Tejocote Capsules and Pieces, both marketed as herbal dietary supplements. The FDA’s analysis indicated the pro…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • NIH launches Linked Discoveries tool on PubMed to streamline finding related biomedical papers
    The National Institutes of Health’s National Library of Medicine has released a pilot version of a new tool called Linked Discoveries on PubMed. The feature adds a button to a paper’s page that op…
    Fierce Biotech · 1mo agoPositive↗ source
  • Novo outlines plan for multiple new drugs to regain market share as shares dip 8%
    At a capital markets day in London, Novo executives presented a roadmap to launch more than five multi-blockbuster drugs by 2030 and target $23 billion in annual sales by 2035, aiming to offset the…
    BioPharma Dive · 1mo agoNegative↗ source
  • Walgreens Specialty Pharmacy highlights holistic support to boost oncology medication adherence
    Advances in oncology are moving care out of the clinic and into patients' homes, with treatments becoming more personalized. This shift means patients often manage complex drug schedules themselves…
    BioPharma Dive · 1mo agoPositive↗ source