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  • 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
  • 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
  • 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
  • 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
  • Novo CEO acknowledges need to rebuild investor confidence after muted capital markets day
    Novo held a capital markets day on Monday in London, where the company outlined its strategy. Investors said the presentation left them underwhelmed. CEO Mike Doustdar acknowledged the reaction, s…
    Endpoints · 1mo agoNegative↗ source
  • Insurers Begin Accelerating AI Adoption After Lagging Behind Providers
    Insurers have traditionally been slower than health-care providers in adopting artificial intelligence tools, but the gap is narrowing. A growing share of insurers now say they plan to significant…
    Endpoints · 1mo agoPositive↗ source
  • Viking touts once-a-month weight loss maintenance data
    Viking Therapeutics says patients who switched to a once-a-month dosing regimen of its obesity drug did not regain much weight after 12 weeks, bolstering the potential of a less frequent schedule.…
    Endpoints · 1mo agoNeutral↗ 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
  • Novo presents low-dose CagriSema data showing competitiveness ahead of approval decision
    Novo used its capital markets day in London to unveil new low-dose data for its experimental metabolic therapy CagriSema. The data indicated that CagriSema performed comparably to Eli Lilly's Moun…
    Endpoints · 1mo agoPositive readoutPositive↗ 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
  • Beacon Therapeutics reports successful gene-therapy trial for rare X-linked retinitis pigmentosa
    Beacon Therapeutics announced that its gene-therapy candidate for X-linked retinitis pigmentosa (XLRP) achieved its primary endpoint in a pivotal trial. The result marks a breakthrough for the rar…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Pentagon defends labeling WuXi AppTec as Chinese military firm, warning of contract limits
    The U.S. Department of Defense is standing by its recent decision to place WuXi AppTec on a list of companies tied to the Chinese military. The designation could bar the contract manufacturing fir…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • FDA provides minimal comment on Grail cancer test before advisory committee meeting
    The FDA typically releases briefing documents that give a clear stance on a drug or diagnostic's safety and efficacy before its advisory committee convenes. In the upcoming meeting concerning Grai…
    Endpoints · 1mo agoRegulatoryNeutral↗ 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
  • Pfizer and Eli Lilly sign 'most favored nation' pricing deals to share foreign price hikes with US government
    Pfizer and Eli Lilly have entered into “most favored nation” agreements with the Trump administration, according to a recent report. The deals require the two companies to remit a portion of the a…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • FDA approves IntraBio's Aqneursa for rare ataxia-telangiectasia disorder
    FDA has granted approval for Aqneursa, a therapy developed by privately held biotech IntraBio, to treat ataxia-telangiectasia, a rare genetic disorder. The decision expands treatment options for pa…
    Endpoints · 1mo agoApprovalPositive↗ source