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  • 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
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  • 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
  • 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
  • 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
  • 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
  • Telix to acquire German radioisotope maker ITM in deal valued up to $2.35 billion
    Telix Pharmaceuticals announced it will purchase ITM Isotope Technologies Munich SE, a German producer of medical radioisotopes, for an upfront payment of $1.65 billion. The transaction could rise…
    Endpoints · 1mo agoDealNeutral↗ source
  • ADARx aims for $318 million IPO as TRexBio and Retension also file
    ADARx Pharmaceuticals, a siRNA biotech currently in Phase 3 trials, announced plans to raise roughly $318 million through an initial public offering. The company is joining other biotech firms suc…
    Endpoints · 1mo agoDealNeutral↗ 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
  • 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
  • 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
  • Regulators call for unified AI guidelines in drug development at RAPS Convergence 2026
    Regulators and industry experts gathered at RAPS Convergence 2026 in Charlotte, NC to discuss the growing role of artificial intelligence in drug development. The panel highlighted that differing…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA staff flag no major concerns for Grail's multi-cancer test ahead of advisory committee
    FDA staff have completed a review of Grail's multi-cancer early detection test and reported no major concerns. The assessment comes as the test approaches a scheduled advisory committee meeting, w…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Novo outlines diversification strategy with new pipeline assets and bolt-on deals
    Novo Pharmaceuticals' chief executive Maziar Mike Doustdar used the company's recent capital-markets day in London to lay out a diversification plan. He said the rebranded firm will focus on expand…
    Endpoints · 1mo agoDealPositive↗ source
  • Cue Biopharma's chronic hives drug clears Phase 2 trial, first immunology data after cancer pivot
    Cue Biopharma announced that its candidate for chronic spontaneous urticaria successfully completed a Phase 2 trial in China. The trial marks the company's first clinical data since it shifted its…
    Endpoints · 1mo agoPositive readoutPositive↗ 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
  • FDA to replace animal testing terms with broader nonclinical language in regulations
    The U.S. Food and Drug Administration announced it will revise its regulations to replace references to animal testing with broader terms such as "nonclinical tests" and "nonclinical studies". The…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Iambic Therapeutics launches next-gen Enchant AI model and inks R&D partnership with AbbVie
    Iambic Therapeutics, a San Diego‑based biotech founded in 2019, announced the release of the next generation of its Enchant artificial‑intelligence model. The updated model is intended to enhance…
    Endpoints · 1mo agoDealPositive↗ source
  • Singapore’s Health Sciences Authority expands regulatory partnerships across Africa, Asia and Europe
    Singapore’s Health Sciences Authority (HSA) announced that it is broadening its regulatory reliance and cooperation framework. The agency is establishing new alliances with regulatory bodies in se…
    raps · 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
  • 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
  • Novartis faces another setback while Novo drops Nordisk partnership
    The latest edition of Endpoints Weekly notes that Novartis experienced another failure, though the newsletter does not provide details about the product or trial. It also reports that Novo Nordisk…
    Endpoints · 1mo agoNegative↗ 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
  • 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