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  • STAT+: Anthropic deepens work with rare disease drugs
    Novo Nordisk sues Eli Lilly over GLP-1s, Medicare pricing plans, and more biotech news from The Readout
    STAT · 3d ago↗ source
  • STAT+: Pharmalittle: We’re reading about Novo suing Lilly over ‘deceptive’ ads, a fugitive’s secret life in biotech, and more
    Novo Nordisk sued Eli Lilly for allegedly running “deceptive” ads to make its obesity and diabetes drugs appear more effective
    STAT · 3d ago↗ source
  • Novartis stays 'geography-agnostic' in dealmaking amid flurry of China deals
    Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma's second quarter earnings call—though major pickups aren’t completely o…
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BioSpace · 3d ago
↗ source
  • The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
    The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
    BioSpace · 3d ago↗ source
  • Broad Institute launches Center for Therapeutic Genetics for rare diseases
    The Broad Institute of MIT and Harvard is teaming up with Boston Children’s Hospital and The Jackson Laboratory to launch a new center focused on genetic treatments for rare diseases, the triumvira…
    Endpoints · 3d ago↗ source
  • STAT+: Nabla’s new CEO on plan to gain market share in a competitive AI scribe environment
    Ambient scribe developer Nabla said Brian Manning will be the Paris-based company's new CEO as it looks to grow in a highly competitive market.
    STAT · 3d ago↗ source
  • 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 · 3d 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    Novo Nordisk sued Eli Lilly for allegedly running a “deceptive” ad campaign that uses “outdated clinical trials” to make its obesity and diabetes drugs appear more effective.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 · 3d 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 · 3d 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 · 3d 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-designin…
    Endpoints · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d ago↗ source
  • Recon: Novo sues Lilly over weight-loss drug ads; Gilead, Merck say HIV pill keeps HIV suppressed in two Phase 3 trials
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 3d ago↗ source
  • FDA cites companies for CGMP violations, informed consent failure
    <p>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 t…
    raps · 3d ago↗ source
  • European Commission publishes guideline on transparency obligations under AI Act
    <p>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,…
    raps · 3d 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 · 4d 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 insu…
    Endpoints · 4d 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…
    Endpoints · 4d 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 · 4d 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 · 4d 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 · 4d 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 · 4d ago↗ source