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  • 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
  • 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 · 1mo agoDealPositive↗ source
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  • 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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
  • 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
  • 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
  • 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
  • TRex Bio and Retension Pharma announce plans for IPOs, outlining biotech pipeline funding
    Biotech companies Retension Pharmaceuticals and TRex Bio have filed with the SEC indicating they intend to go public this year, adding to the current wave of biotech IPOs. TRex Bio said it will us…
    Fierce Biotech · 1mo agoDealNeutral↗ 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
  • Cue Biopharma's CUE-221 meets primary endpoint in phase 2 CSU trial, eyes phase 2b/3
    Cue Biopharma reported that its chronic spontaneous urticaria (CSU) candidate CUE-221 achieved the primary endpoint in a midstage study conducted in China. The trial enrolled 145 patients who rece…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ 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
  • Beacon Therapeutics reports positive pivotal trial results for X-linked retinitis pigmentosa gene therapy
    Beacon Therapeutics said its gene therapy for X-linked retinitis pigmentosa (XLRP) met the primary endpoint in a phase 2/3 Vista study. The trial enrolled 85 male patients and compared two dose lev…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • FDA clears Aptitude’s latest Metrix molecular dx to test for COVID
    The FDA granted Aptitude its first 510(k) clearance for the next-generation Metrix COVID diagnostic that features three-times greater sensitivity with 30% faster results that its original emergency…
    Fierce Biotech · 1mo agoApprovalPositive↗ 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
  • Novo Nordisk acquires three early-stage obesity programs from Kallyope
    Novo Nordisk announced the purchase of three early-stage obesity drug programs from New York‑based biotech Kallyope, expanding its metabolic pipeline. The acquired assets are not GLP‑1 incretins.…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Electra Therapeutics raises $350M in biotech IPO, fueling rare disease drug development
    Electra Therapeutics completed a $350 million initial public offering, becoming the 21st biotechnology company to go public in 2026. The strong demand for its shares highlights continued investor a…
    BioPharma Dive · 1mo agoDealPositive↗ source