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  • 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
  • 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
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  • 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
  • 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
  • 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
  • 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 · 1mo agoRegulatoryNegative↗ 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
  • 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
  • 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
  • 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
  • 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