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  • Amgen seeks FDA hearing to keep rare kidney drug Tavneos amid safety concerns
    Amgen has asked the U.S. Food and Drug Administration for a hearing to argue against a proposed withdrawal of its rare‑disease drug Tavneos. The company submitted a data package containing real‑wo…
    BioSpace · 3mo agoRegulatoryNegative↗ source
  • Fatal gene-editing trial in China sparks ethics and oversight concerns
    A six-year-old girl in China died after receiving an experimental brain-directed CRISPR therapy, according to a report in Science. The tragedy has intensified calls for stronger ethical review and…
    STAT · 3mo agoRegulatoryNegative↗ source
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  • Roche drops Carmot’s acmopatide after Phase 2 success, shifts focus to enicepatide for weight loss and diabetes
    Roche announced it will stop developing acmopatide, an investigational obesity treatment acquired from Carmot Therapeutics. Acmopatide had met its primary endpoint in a Phase 2 trial in type 1 dia…
    BioSpace · 3mo agoNeutral↗ source
  • Scribe Therapeutics upsizes IPO to $128.7 million to fund lipid-lowering gene therapy
    Scribe Therapeutics announced pricing its initial public offering at $128.7 million, surpassing the $96 million target it had set earlier in the week. The company sold 8.6 million shares at $15 ea…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Eli Lilly to file FDA application for obesity drug retatrutide after Phase 3 trial results
    Eli Lilly announced that two additional Phase 3 trials of its experimental obesity medicine retatrutide met their primary goals, and the company plans to submit an FDA application for the drug next…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • Eli Lilly to seek FDA approval for retatrutide in early 2027 after Phase 3 trials show over 20% weight loss
    Eli Lilly said its next‑generation obesity drug retatrutide produced substantial weight loss in two late‑stage Phase 3 studies. The data were presented from the TRIUMPH‑2 and TRIUMPH‑3 trials, whic…
    BioSpace · 3mo agoPositive readoutPositive↗ source
  • Eli Lilly’s retatrutide meets primary goals in phase 3 obesity trials with ~22% weight loss but no clear heart benefit
    Eli Lilly reported that its triple‑hormone agonist retatrutide achieved the primary endpoints in two phase 3 obesity studies, TRIUMPH‑2 and TRIUMPH‑3. The drug was tested at a 12 mg dose against pl…
    Fierce Biotech · 3mo agoPositive readoutNeutral↗ source
  • Lilly's obesity drug shows strong weight loss but fails to demonstrate cardiovascular benefit in heart disease trial
    Eli Lilly released Phase 3 results for its next‑generation obesity therapy retatrutide, showing it produces substantial weight loss in a trial of nearly 2,000 participants with severe obesity and e…
    STAT · 3mo agoNegative readoutNeutral↗ source
  • Eli Lilly's retatrutide shows strong weight loss but no clear heart risk reduction in Phase 3 trial
    Eli Lilly released new data from a Phase 3 trial of retatrutide, its next‑generation obesity drug. The study enrolled nearly 2,000 participants with severe obesity and existing heart disease, some…
    STAT · 3mo agoNegative readoutNegative↗ source
  • FDA advisory panel to decide on compounding of synthetic peptides amid safety concerns
    The FDA advisory committee is meeting to consider whether compounding pharmacies should be allowed to manufacture seven specific synthetic peptides. Use of these peptides has grown in the United St…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • AstraZeneca’s rare disease drug Wainua fails Phase 3, narrowing path to $80 billion sales goal
    AstraZeneca announced that its rare disease therapy Wainua did not meet its primary endpoints in a Phase 3 trial, ending plans to broaden the drug’s label for transthyretin amyloidosis cardiomyopat…
    BioSpace · 3mo agoNegative readoutNegative↗ source
  • Repligen to acquire BioLife Solutions for $1.5 billion, boosting its role in cell therapy preservation
    Repligen announced a $1.5 billion acquisition of BioLife Solutions, a company whose CryoStor media is used to preserve cell therapies during storage and transport. BioLife’s products are employed…
    BioSpace · 3mo agoDealPositive↗ source
  • Crystalys Therapeutics raises $130M Series B to advance gout drug dotinurad toward global launch
    Crystalys Therapeutics announced a $130 million Series B financing to move its gout drug dotinurad through late-stage trials and prepare for commercial launch. The round was led by Frazier Life Sc…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • FDA approves Merck’s oral PCSK9 inhibitor Lipfendra, but cardiologists question its immediate impact
    The FDA has granted approval to enlicitide, marketed by Merck as Lipfendra, marking the first oral PCSK9 inhibitor for lowering blood cholesterol. The drug arrives as new clinical guidelines encou…
    STAT · 3mo agoApprovalNeutral↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 3mo agoRegulatoryPositive↗ source
  • Arrowhead reports Phase 3 data showing potentially best-in-class triglyceride reduction, eyes FDA filing
    Arrowhead Pharmaceuticals announced topline results from two late-stage Phase 3 trials (SHASTA-3 and SHASTA-4) of its siRNA drug plozasiran in patients with severe hypertriglyceridemia (sHTG). Th…
    BioSpace · 3mo agoPositive readoutPositive↗ source
  • Royalty Pharma pays $125M upfront for royalty stake in AstraZeneca’s ATTR drug cliramitug
    Royalty Pharma has entered a deal to acquire a royalty interest in a transthyretin amyloidosis drug being developed by AstraZeneca. The agreement involves an upfront payment of $125 million to Neu…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Pharma pushes back on China restrictions as AI VC raises $800M and Merck unveils cholesterol pill; Celldex reports trial setback
    Pharma companies are working to ease the impact of broad new restrictions in China, seeking ways to maintain market access amid tighter regulatory scrutiny. An AI‑focused venture capital firm anno…
    STAT · 3mo agoNeutral↗ source
  • Summit Therapeutics' ivonescimab shows improved survival trend in extended follow-up, easing investor doubts
    A new analysis of Summit Therapeutics and Akeso's dual‑acting cancer immunotherapy ivonescimab indicates that the drug's impact on overall survival has grown with longer observation. The extended d…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Novartis beats sales expectations as Q2 revenue rises to $14.4B, eyes upcoming study readouts
    Novartis reported a modest rise in second‑quarter sales, lifting its share price after the company posted a 1% increase in net sales to $14.4 billion, surpassing analyst forecasts for a decline. A…
    BioPharma Dive · 3mo agoEarningsPositive↗ source
  • Novartis says it will keep seeking sub-$2 billion bolt-on deals worldwide, staying geography-agnostic
    Novartis CEO Vas Narasimhan told investors on the second‑quarter earnings call that the company will continue to pursue bolt‑on acquisitions below $2 billion and has no plans to overhaul its busine…
    BioSpace · 3mo agoDealNeutral↗ source
  • Crystalys mines $130M series B to push gout drug through phase 3
    Crystalys Therapeutics has raised $130 million in series B financing to advance the development of its gout drug dotinurad and prepare for a potential commercial launch.
    Fierce Biotech · 3mo agoNeutral↗ source
  • Scribe Therapeutics targets $96 million IPO to fund PCSK9 gene-silencing program
    Scribe Therapeutics, a Bay Area biotech focused on genetic medicines, filed with the SEC outlining plans for an initial public offering on Nasdaq. The company aims to sell 7.1 million shares at $1…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Latigo Biotherapeutics Announces Plans for Nasdaq IPO to Fund Non-Opioid Pain Drug Development
    Latigo Biotherapeutics, a Westlake BioPartners spin‑out founded in 2018, said it will seek a Nasdaq listing under the ticker LTGO. The company develops non‑opioid analgesics that block sodium ion…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • HHS vaccine committee receives new charter amid broader health policy updates
    The U.S. Health and Human Services vaccine advisory panel has been granted a new charter, a change that was noted quietly in a recent health newsletter. The same briefing highlighted other policy…
    STAT · 3mo agoRegulatoryNeutral↗ source