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1,446 stories matching this filter · ← front page

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  • 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 · 1mo 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 · 1mo agoLayoffsNegative↗ source
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  • 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 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
  • 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
  • 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
  • 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 · 1mo 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 · 1mo 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 · 1mo 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
  • 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 · 1mo agoRegulatoryNeutral↗ source
  • Beacon eye gene therapy hits mark in late-stage study
    Beacon claimed the findings represent the first time a treatment for X-linked retinitis pigmentosa, a rare and potentially blinding condition, met its main goal in a pivotal trial.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Western licensing deals for Chinese radioligand therapies to jump in 2027, Sleuth forecasts
    Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
    BioSpace · 1mo ago↗ source
  • Ultragenyx receives FDA approval for Fayuvi, first therapy for Sanfilippo syndrome type A, priced at $3.95 M
    The FDA has approved Ultragenyx's gene therapy rebisufligene etisparvovec, to be sold under the brand name Fayuvi, for the treatment of Sanfilippo syndrome type A, an ultra-rare progressive neurolo…
    BioSpace · 1mo agoApprovalPositive↗ source
  • China unveils five-year plan to grow biotech sector from $3M to $522B by 2030
    China's Ministry of Industry and Information Technology released a new five-year biotech plan that sets out ambitious growth targets for the sector. The plan aims to expand the industry from rough…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Xenon shares tumble up to 30% after pausing depression trial over neuropsychiatric events
    Xenon Pharmaceuticals announced it is pausing enrollment in its depression trial for the drug azetukalner after neuropsychiatric adverse events emerged that were not observed in earlier testing. A…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Electra Therapeutics raises $350M in IPO to fund pivotal immune-disease antibody development
    Electra Therapeutics announced an initial public offering that raised $350 million, exceeding its earlier target. The IPO consisted of 23.3 million shares sold at $15 per share, and underwriters w…
    BioSpace · 1mo agoDealPositive↗ source