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  • FDA approves Lilly's new combination therapy for advanced breast cancer
    The U.S. Food and Drug Administration has granted approval for a new combination drug regimen developed by Eli Lilly for patients with an advanced form of breast cancer. The therapy pairs two agen…
    STAT · 1mo agoApprovalPositive↗ 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
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  • 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
  • Novo Nordisk vows to launch five multi-blockbuster drugs by 2030 as it shifts toward consumer-style products
    Novo Nordisk used its London capital markets day to reassure investors that the company will broaden its pipeline and market new medicines more like consumer products than traditional drugs. The C…
    STAT · 1mo agoNeutral↗ 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
  • New KRAS-targeting drug daraxonrasib approved for pancreatic cancer as experts call for $100 billion NIH budget
    The FDA has approved daraxonrasib, a therapy from Revolution Medicines that targets the KRAS mutation in pancreatic cancer. The drug is intended for patients who have already received treatment and…
    STAT · 1mo agoApprovalPositive↗ 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
  • 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
  • Congress pushes back on White House plan to place political appointees on NIH grant reviews
    Members of Congress have voiced strong opposition after a leak revealed a White House proposal to create a commission of political appointees that would review every NIH grant. The idea reportedly…
    STAT · 1mo agoRegulatoryNegative↗ 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
  • 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
  • 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
  • Alkermes' orexin agonist ALKS 7290 shows promise in early-stage ADHD trial
    Alkermes reported results from a Phase 1 study of its orexin agonist ALKS 7290, a drug class previously explored for rare sleep disorders. The trial enrolled adults with moderate to severe ADHD, a…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Novo Nordisk outlines new obesity and consumer-focused strategy, targets five multi-blockbusters by 2030
    Novo Nordisk used its capital markets day to reassure investors by unveiling a plan to broaden its pipeline beyond diabetes and obesity. The company said it will aim to launch at least five multi-b…
    STAT · 1mo agoNeutral↗ source