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  • Lilly’s triple-G drug hits 22.6% weight loss, but impact on reducing cardio risk is less clear
    Eli Lilly’s triple-G drug retatrutide has hit the primary endpoints of a pair of phase 3 obesity trials, although the peak weight loss fell short of previous trials while failing to prove the drug…
    Fierce Biotech · 5d ago↗ source
  • Roche Diagnostics growth remains muted amid China headwinds
    Roche’s Diagnostics division continues to battle growth headwinds, notching a 3% increase in sales.
    Fierce Biotech · 5d ago↗ source
  • Australian biopharma Clinuvel to shed up to 20% of workforce in move to US
    Australian biopharma Clinuvel Pharmaceuticals is moving its headquarters to the U.S.— but up to a fifth of the company’s workforce won’t be staying for the trans-Pacific pivot.
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Fierce Biotech · 5d ago
↗ source
  • Roche drops TCE for lupus, but hasn’t given up on autoimmune cell therapies
    Roche may have scrapped work on a T-cell engager being evaluated for lupus, but the company’s head of pharma told Fierce that still has a strategy for developing cell therapies for autoimmune disea…
    Fierce Biotech · 5d ago↗ source
  • FDA clears Johnson & Johnson’s surgical robot for ‘the next era in surgery’
    The FDA has authorized Johnson & Johnson’s Ottava Robotic Surgical System as the company looks to compete with Intuitive Surgical and Medtronic.
    Fierce Biotech · 5d ago↗ source
  • Recon: J&J nabs FDA authorization for general surgery robot; FDA urged to ban DTC drug ads
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 5d ago↗ source
  • Euro Roundup: EMA seeks feedback on planned changes to guidance on biosimilar efficacy studies
    <p>The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.</p>
    raps · 5d ago↗ source
  • Study: Most sponsors complete postmarketing trials, publish results
    <p>Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the…
    raps · 5d ago↗ source
  • FDA advisory committee backs two controversial peptides
    <p>An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for woun…
    raps · 5d ago↗ source
  • Vertex was sole bidder in high-premium Crinetics acquisition
    <p>Analysts expect new details on the lead-up to the deal “are likely to reignite” investor scrutiny that Vertex overpaid in what’s poised to be its largest-ever transaction.</p>
    BioPharma Dive · 5d ago↗ source
  • GSK lung cancer drug gets speedy approval following $10.6B deal
    <figure><div><img src="https://imgproxy.divecdn.com/c0irKiK7j9tqBFXMPegw7r6KQcBI9zHl6OgHMT-b53A/g:nowe:0:353/c:4765:2692/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9OZXdfR1NLSC5qc…
    BioPharma Dive · 5d ago↗ source
  • FDA swiftly puts Makary era in the rearview mirror
    As the White House mulls a pick to lead the FDA, the Trump administration has been washing away the mark of former Commissioner Marty Makary, in a refresh that includes everything from reconsidered…
    Endpoints · 5d ago↗ source
  • Former FDA cancer chief Pazdur says the agency should restructure
    Richard Pazdur, who spent more than two decades leading the FDA’s cancer drug reviews, said the agency has a “golden opportunity” to restructure after being struck last year by the Trump administra…
    Endpoints · 5d ago↗ source
  • FDA approves Nuvalent's cancer drug, a week after GSK closed $10.6B buyout
    GSK's $10.6 billion acquisition of Nuvalent is delivering surprisingly early results. The FDA on Wednesday approved one of Nuvalent's lung cancer medicines two months earlier than projected, and…
    Endpoints · 5d ago↗ source
  • Arrowhead hits ‘best-case scenario’ with latest results for fat-lowering drug
    <figure><div><img src="https://imgproxy.divecdn.com/8hRa8ccyqK4EhEh4oXaIz1XS7XE4MZBhJhutfBJVSSU/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNzUyMzcxMjg5LmpwZ…
    BioPharma Dive · 5d ago↗ source
  • Arrowhead’s gene silencer competitive with Ionis’ in triglyceride disease
    Arrowhead Pharmaceuticals’ lipid-lowering drug has hit in two late-stage trials that could expand its use into a much wider population. Data shared Wednesday showed that Arrowhead’s gene silencer…
    Endpoints · 5d ago↗ source
  • Trump threatens tariffs on imported generic drugs
    <figure><div><img src="https://imgproxy.divecdn.com/FZSdFBL2W8A453vDL0XpB2NIs52eHj5QA0Y0T_Dy_Bs/g:nowe:0:0/c:3200:1807/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0…
    BioPharma Dive · 5d ago↗ source
  • NIH joins Trump’s $5B AI mission with biomedical research push
    The U.S. Department of Health and Human Services announced new efforts Wednesday aligned with President Donald Trump’s artificial intelligence-driven Genesis Mission. The centerpiece of HHS’ partic…
    Fierce Biotech · 5d ago↗ source
  • Mentari adds $200M to migraine mission; Royalty's latest ATTR-CM deal
    Another $200M for Mentari: Migraine drug developer Mentari Therapeutics has lined up a second private placement as it works to close its reverse merger with InMed Pharmaceuticals. The Paragon Thera…
    Endpoints · 5d ago↗ source
  • Q&A: Lilly returns to neuropsych and looks ahead to Alzheimer's prevention
    LONDON — Eli Lilly, the world’s biggest drugmaker, appears to be getting more ambitious about tackling brain diseases. Last week, the company announced it would pay $2.8 billion upfront to acquir…
    Endpoints · 5d ago↗ source
  • Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 5d ago↗ source
  • Crystalys gets $130M to take Sobi-rivaling gout drug to market
    A San Diego biotech has raised an additional $130 million to get a gout drug that's already approved in Japan and China onto the US and European markets. Crystalys Therapeutics reeled in the Seri…
    Endpoints · 6d ago↗ source
  • Crystalys nets $130M more to push gout drug through late-stage tests
    <figure><div><img src="https://imgproxy.divecdn.com/THeKNpwt2ETxP7Nf-ec1mU-DtgG84p4ktQEqFznWC1c/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xODUxMTEwNjQucG5n.…
    BioPharma Dive · 6d ago↗ source
  • Summit reports two-year survival data for Western patients, though context lacking
    Summit Therapeutics unveiled additional follow-up data on its experimental cancer drug ivonescimab, and how its benefit compares between Asian and Western patients. But key context remains unknown.…
    Endpoints · 6d ago↗ source
  • Celldex scraps antibody in prurigo nodularis after Phase 2 flop
    Celldex said on Tuesday it will stop investigating its mast cell-targeting monoclonal antibody in a type of chronic itch disease after it failed on all efficacy measures in a mid-stage trial. Top…
    Endpoints · 6d ago↗ source