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1,872 stories matching this filter · ← front page

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  • Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review
    If approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Th…
    BioSpace · 10d ago↗ source
  • STAT+: Novo Nordisk sues Eli Lilly over GLP-1 drug ads it calls ‘deceptive’
    Novo Nordisk sued Eli Lilly for allegedly running a “deceptive” ad campaign that uses “outdated clinical trials” to make its obesity and diabetes drugs appear more effective.
    STAT · 10d ago↗ source
  • A renewed push from the right against abortion pills
    The latest on cyclospora, THC sodas at the grocery store, and more health news from Morning Rounds
    STAT
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· 10d ago
↗ source
  • Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs
    Axiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a global company.
    BioSpace · 10d ago↗ source
  • A-Alpha Bio starts AI antibody data consortium with GSK, Boltz
    Biopharma's AI engines need more data. And David Younger thinks there's a great business to sell those data to them. Younger's startup, A-Alpha Bio, has spent months studying how protein-designing…
    Endpoints · 10d ago↗ source
  • THC drinks are sold beside sodas, iced tea, and even chocolate milk, often in violation of state laws
    THC drinks, which have exploded in popularity in recent years, are sold in retail stores beside sodas, iced tea, and even chocolate milk, often in violation of state laws.
    STAT · 10d ago↗ source
  • Opinion: How a controversial rule could hurt the NIH’s ability to manage risk
    The proposed rule could “weaken the NIH’s benign influence over research risks,” writes Doni Bloomfield.
    STAT · 10d ago↗ source
  • Opinion: Science and the public are learning the wrong lessons from Covid
    “Post-pandemic polarization threatens to lock our memories into attractive, untrue conclusions that will leave us unprotected next time,” write Marc Lipsitch and Sara Cody.
    STAT · 10d ago↗ source
  • STAT+: Makers of rare disease drugs seek exemption from Trump’s price-cut pilots
    A coalition of biotech firms is lobbying to exclude orphan drugs from new federal pilot programs aimed at lowering Medicare drug costs.
    STAT · 10d ago↗ source
  • Recon: Novo sues Lilly over weight-loss drug ads; Gilead, Merck say HIV pill keeps HIV suppressed in two Phase 3 trials
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 10d ago↗ source
  • FDA cites companies for CGMP violations, informed consent failure
    The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing to s…
    raps · 10d ago↗ source
  • European Commission publishes guideline on transparency obligations under AI Act
    The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) systems in fulfilling transparency obligations under the EU’s AI Act, in…
    raps · 10d ago↗ source
  • FDA still focused on lettuce supplier as source of parasite, despite faulty test result
    The FDA said Monday it is still focused on lettuce from Taylor Farms as the source of a multistate outbreak of a diarrhea-causing parasite, despite a faulty test result.
    STAT · 11d ago↗ source
  • Tempus to acquire cancer test maker Personalis for $1.5B
    Tempus AI’s planned acquisition follows recent interest in blood-based cancer tests across the medtech industry.
    BioPharma Dive · 11d ago↗ source
  • Tempus to buy cancer test-maker Personalis for $1.5B
    Tempus AI’s planned acquisition follows recent interest in blood-based cancer tests across the medtech industry.
    BioPharma Dive · 11d ago↗ source
  • UnitedHealth Group lays out progress in AI push
    After announcing a hefty investment in AI earlier this year, UnitedHealth laid out how it's using the technology across its business in a quarter that landed better than expected. The health insure…
    Endpoints · 11d ago↗ source
  • House lawmakers back trade probe of China biotech, sequencing
    At least 10 House lawmakers are backing a US trade panel’s probe of China’s biotech sector and related pricing practices, encouraging future executive action. In a letter sent to Secretary of the U…
    Endpoints · 11d ago↗ source
  • Samsung Bio to step into peptides in $1.8B buy for PolyPeptide
    Samsung Biologics is set to branch out to peptide ingredient manufacturing with plans to buy Swiss CDMO PolyPeptide for $1.8 billion in cash. The purchase, announced Monday, would be the Korean ...
    Endpoints · 11d ago↗ source
  • Pain drugmaker Latigo outlines plans to go public
    The Westlake-founded company specializes in non-opioid drugs that target sodium ion channels, and is now adding to what’s already been a busy month for the biotech IPO queue.
    BioPharma Dive · 11d ago↗ source
  • Anthropic's life sciences plans: Mystery programs, Nobel hires, M&A and big ambition
    A year ago, Anthropic’s life sciences plans were basically just a blog post by its CEO. In late 2024, Dario Amodei wrote a 13,000-word memo naming biology and neuroscience among his ...
    Endpoints · 11d ago↗ source
  • Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromab
    Scribe writes in $96M IPO: The gene editing biotech expects net proceeds of about $96 million if it prices its Nasdaq listing at $14 per share, the midpoint of the ...
    Endpoints · 11d ago↗ source
  • Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics
    Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst caut…
    BioSpace · 11d ago↗ source
  • J&J, AbbVie said to have also looked at AtaiBeckley before Lilly’s $2.8B deal
    Johnson & Johnson and AbbVie, the two pharma giants already in the psychedelic space, also eyed AtaiBeckley, according to a source familiar with the situation, but didn’t make an offer before Eli L…
    Endpoints · 11d ago↗ source
  • STAT+: The next step of site-neutral, and a fiery PBM hearing
    Medicare proposes to reduce payments to hospitals for certain drugs and imaging services.
    STAT · 11d ago↗ source
  • FDA’s radical transparency policy for rejections runs into legal uncertainty
    Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.
    BioSpace · 11d ago↗ source