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  • 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
  • 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
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  • 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
  • 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
  • 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
  • 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
  • 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
  • STAT launches first trust-in-science reporter to explore declining public confidence in health research
    Alex Hogan, senior multimedia producer at STAT, hosts the weekly video series STATus Report and recently aired an episode titled “Why is trust in science important?”. The episode notes that public…
    STAT · 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
  • 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
  • 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
  • Addiction clinics see rising cases of kratom and 7-OH withdrawal
    Addiction clinics are seeing a surge in patients dependent on potent kratom and 7-OH products.
    STAT · 1mo agoRegulatoryNeutral↗ 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
  • Experts urge ClinicalTrials.gov to add pregnancy and lactation checkbox to aid trial enrollment
    Patients who are pregnant or nursing often struggle to locate clinical trials that accept them, and clinicians face the same obstacle when advising participants. ClinicalTrials.gov lists more than…
    STAT · 1mo agoPositive↗ source
  • Trump calls for new vaccine while echoing vaccine misinformation
    A recent STAT newsletter reported that President Donald Trump announced he will demand a new vaccine, echoing long-standing vaccine misinformation. The claim was made a day after health secretary R…
    STAT · 1mo agoNegative↗ source