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Obesity drug progress toward BLA
Eli Lilly advanced its “triple-G” obesity program as additional Phase 3 results cleared the path toward a U.S. regulatory filing for retatrutide. The company reported top-line readouts across two...
FDA advisory panel backs broader access to unapproved peptides
An FDA advisory panel voted narrowly in favor of expanding compounding for certain unapproved peptides, setting up a consequential next step in a high-profile regulatory fight. The panel supported...
CRISPR biotech raises capital in hot IPO window
Scribe Therapeutics kicked off trading after pricing an upsized initial public offering focused on CRISPR-based therapies for cardiovascular and metabolic diseases. The company raised about $129...
CAR-T toxicity genomics in Yescarta trials
Researchers analyzing patient data from Kite’s Yescarta CAR-T trials identified genetic signatures associated with toxicity risk. In a study published in Science Immunology, investigators led by...
EU regulator setback for Zevra’s NPC therapy
Zevra Therapeutics received a negative CHMP opinion in the EU for arimoclomol in Niemann-Pick disease type C, despite prior U.S. approval. The EMA’s Committee for Medicinal Products for Human Use...
CDMO M&A expands peptide manufacturing footprint
Samsung Biologics proposed its largest-ever acquisition, launching an all-cash tender offer to buy PolyPeptide Group, a CDMO specializing in peptide-based APIs. The company offered CHF 44.31 per...
Royalty deal targets ATTR-CM amyloid depletion
Royalty Pharma secured a $425 million interest in Neurimmune’s cliramitug, paying $125 million upfront for a royalty stream tied to worldwide sales, with additional payments contingent on clinical...
Organs survive longer via supercooling platform research
A team led by Texas A&M University researchers reported that pig kidneys can be supercooled to -4 °C without ice formation and preserved for days before rewarming and transplantation into animals....
Cell therapy platform moves toward solid tumor development
Tikva Allocell secured an $8 million Series A to advance TAVST-01, an engineered allogeneic cell therapy program aimed at adult and pediatric patients with solid tumors. The funding supports...
Regulatory / approvals
GSK’s newly acquired ROS1 inhibitor zidesamtinib (Jideytro) won rapid U.S. FDA approval for adults with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC) who...
Late-stage obesity efficacy and filing momentum
Eli Lilly’s retatrutide added to its regulatory path after two additional Phase 3 obesity readouts, with the company signaling it will seek FDA approval early next year. In the Triumph-2 and...
Enterprise biotech finance: IPO and public-market momentum
Scribe Therapeutics launched a second-half IPO push with a rare gene-editing listing priced to raise about $128.7 million, above initial expectations. The in vivo gene editing company priced 8.6...
M&A: CDMO expansion into peptides
Samsung Biologics moved aggressively to expand into peptide therapeutics by launching an all-cash tender offer for Switzerland-based PolyPeptide Group for about $1.8 billion. The deal is Samsung...
Regulatory uncertainty: compounding peptides under FDA advisory debate
An FDA advisory panel narrowly recommended expanding compounding access for certain unapproved peptides, despite limited evidence and safety concerns raised by scientists. The Pharmacy Compounding...
EU regulators: next rare-disease approvals and setbacks
The European Medicines Agency’s CHMP backed Minoryx’s ALD therapy while rejecting Zevra’s Meplyffa in a set of rare-disease opinions that highlight uneven European momentum. Minoryx’s neurological...
Pipeline failure in late-stage dermatology
Sanofi moved to stop pursuing approval for amlitelimab in atopic dermatitis, formally halting development of the troubled immune drug that had been positioned as a potential successor to Dupixent....
Regulatory / product milestone: lab diagnostics clearance
Roche Diagnostics secured FDA clearance for a molecular vaginitis assay designed to detect pathogens associated with bacterial vaginosis and Candida vaginitis using clinician-collected or...
Clinical failure and ethics scrutiny: gene-editing death case
A Science investigation into the death of a six-year-old girl in China after receiving an experimental brain-directed CRISPR therapy revived ethics and oversight questions for gene-editing...
Oncology clinical breakthrough: RAS(ON) inhibition extends survival in mPDAC
A Phase 3 trial reported that daraxonrasib—an oral RAS(ON) multiselective inhibitor—significantly improved overall survival and progression-free survival versus investigator’s choice chemotherapy...