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1,218 stories matching this filter · ← front page

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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 · 28d agoPositive readoutPositive↗ source
  • Roche’s enicepatide shows dose-dependent blood sugar and weight loss in Phase 2 diabetes trial
    Roche reported that its injectable GLP-1/GIP dual agonist enicepatide, acquired through the Carmot Therapeutics purchase, achieved reductions in blood glucose and body weight in a Phase 2 study of…
    BioSpace · 28d agoPositive readoutPositive↗ source
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Pain654
Nephrology634
  • 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 · 28d agoPositive readoutPositive↗ source
  • Compass Therapeutics to file BLA for tovecimig despite FDA call for new trial
    Compass Therapeutics announced it will continue pursuing a biologics license application (BLA) for its bispecific antibody tovecimig aimed at advanced biliary tract cancer, even after the FDA sugge…
    BioSpace · 28d agoRegulatoryNegative↗ source
  • Novo Nordisk cuts 13,000 jobs to redirect funds toward R&D
    Novo Nordisk announced further workforce reductions, bringing total departures to about 13,000 over the past year. CEO Maziar Mike Doustdar said the cuts are intended to free up capital for resear…
    BioSpace · 28d agoLayoffsNegative↗ source
  • Boehringer Ingelheim to invest up to $1B in AI-driven solid tumor partnership with Envisagenics
    Boehringer Ingelheim announced a partnership with Envisagenics to develop precision oncology therapies that use artificial intelligence to identify cancer-specific RNA splicing alterations. The co…
    BioSpace · 28d agoDealPositive↗ 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
  • Lilly presents early data supporting GLP-1/GIP candidate's potential in depression, alcohol use disorder
    With a trillion-dollar market cap and a wildly successful GLP-1 portfolio, Eli Lilly isn’t resting on its laurels. At the Psych Congress 2026, the company presented early-stage data that could supp…
    BioSpace · 28d agoRegulatoryNeutral↗ source
  • Vertex opens up larger kidney disease opportunity with mid-stage readout
    While Vertex is laser-focused on an upcoming FDA decision for povetacicept in immunoglobulin A nephropathy, the APOL1 inhibitor inaxaplin has demonstrated potential “best-in-class” data in a differ…
    BioSpace · 28d ago↗ source
  • Telix to acquire ITM Isotope Technologies for $1.65 billion, adding late-stage radiopharma asset ITM-11
    Telix Pharmaceuticals announced it will purchase Germany‑based ITM Isotope Technologies Munich for $1.65 billion in cash. The agreement also provides for up to $700 million in milestone payments l…
    BioSpace · 29d agoDealPositive↗ 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 · 29d agoDealPositive↗ source
  • Experts see Replimune’s Tudriqev approval as a step toward broader use of localized cancer therapies
    Replimune received FDA approval last month for Tudriqev, an oncolytic virus injected directly into melanoma tumors, marking only the second such approval for a therapy delivered straight into a tum…
    BioSpace · 1mo agoApprovalPositive↗ source
  • Transposase-based cell line platform speeds development and raises protein yields for complex biologics
    Advanced cell line development tools are helping biopharma tackle the expression and stability challenges of increasingly complex molecules such as bispecifics and trispecifics. The article highli…
    BioSpace · 1mo agoPositive↗ 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 · 29d agoRegulatoryNegative↗ 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 · 29d agoNegative↗ source
  • Sleuth predicts surge in Western licensing of Chinese radioligand therapies by 2027
    Sleuth, a biopharma intelligence platform, says that while Chinese radiopharmaceutical assets have seen few licensing deals so far, the market is set to change. The firm notes that China now runs…
    BioSpace · 29d agoNeutral↗ source
  • Novo outlines $23 billion 2035 revenue target, but investors react with a 7% share drop
    Novo’s chief executive used the recent Capital Markets Day to lay out a long‑term growth plan that targets $23 billion in annual sales by 2035. The strategy emphasizes expanding beyond its flagship…
    BioSpace · 29d agoNegative↗ source
  • Novo acquires three early-stage obesity assets from Kallyope to broaden pipeline amid investor pressure
    Investors have been urging Novo to expand its pipeline beyond the semaglutide franchise that drives most of its sales. In response, Novo announced it will acquire three early-stage obesity candida…
    BioSpace · 29d agoDealPositive↗ 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
  • Healthcare systems lag behind rapid expansion of GLP-1 therapies, raising care and trust challenges
    GLP-1 drugs have demonstrated that pharmacological treatment can effectively reduce obesity, and regulators have now approved them for additional uses such as cardiovascular risk reduction, metabol…
    BioPharma Dive · 1mo agoNeutral↗ source
  • FDA’s new CBER and CDER heads back adaptive framework for rare disease therapies
    Newly appointed permanent directors of FDA’s CBER and CDER, Karim Mikhail and Michael Davis, indicated they will continue the agency’s push for an adaptive regulatory framework aimed at rare diseas…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Par Health recalls two lots of dexmedetomidine infusion due to particulate contamination
    Par Health announced a voluntary recall of two lots of its dexmedetomidine HCl in 0.9% sodium chloride injection, which is used for intravenous sedation. The recall was initiated after testing ide…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Otsuka ICU Medical recalls one lot of 0.9% Sodium Chloride injection after possible potassium chloride mix-up
    Otsuka ICU Medical LLC announced a voluntary recall of a single lot of its 0.9% Sodium Chloride Injection, USP, 100 mL. The recall was triggered after a customer complaint revealed that the overwr…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • CooperSurgical issues recall of INCA infant nasal CPAP sets over loose connection risk
    CooperSurgical has announced a recall of its INCA infant nasal CPAP complete and replacement sets. The recall is due to a potential loose connection between the flexible tubing and the nasal cannu…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Compass eyes J&J’s Spravato playbook for upcoming psychedelic drug COMP360 launch
    Compass executives told BioPharma Dive that, if the FDA approves their treatment, they plan to follow the commercial strategy Johnson & Johnson used for its ketamine spray Spravato. When Spravato…
    BioPharma Dive · 29d agoRegulatoryNeutral↗ source