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Obesity drug development and regulatory path
Eli Lilly advanced its obesity and cardiometabolic pipeline after posting additional Phase 3 data for retatrutide, strengthening the company’s runway toward an FDA filing. The updates included...
FDA panel actions on compounded peptides
The FDA’s Pharmacy Compounding Advisory Committee (PCAC) issued a narrowly positive recommendation on expanding access to compounded, unapproved peptides, setting up additional FDA review...
Corporate M&A in bioprocessing and life-science software
Dassault Systèmes moved to consolidate life-science data and analytics capabilities by agreeing to acquire Arisglobal for up to $2 billion. The deal is designed to merge Arisglobal’s AI-driven...
Oncology approvals after large acquisitions
GSK’s recently acquired Nuvalent asset produced early regulatory payoff as the FDA approved zidesamtinib, now marketed as Jideytro, for ROS1-positive advanced or metastatic non-small-cell lung...
Neurodevelopmental preclinical therapeutics and mTOR signaling
UCLA Health researchers reported that a single dose of rapamycin improved multiple autism-like features in a maternal inflammation mouse model, with effects appearing rapid but temporary. The...
Regulatory overhaul moves in South Korea’s drug pricing system
South Korea advanced a major overhaul to drug review and pricing, aiming to rebalance incentives toward innovation while tightening controls for generics. The reforms target how the country...
Cell and gene therapy manufacturing quality—particulates CMC workarounds
Cell-therapy manufacturers are adopting new strategies to handle unclear regulatory expectations for particulates testing and control, particularly for opaque, single-use-bag workflows. Industry...
Gene regulation platform advances via NIH 4D Nucleome
NIH’s 4D Nucleome program delivered a new wave of spatial and epigenomic findings across eight papers published in Science and Science Advances. The studies apply single-cell multi-omics to map...
Biotech financing momentum and clinical-stage gout program
Crystalys Therapeutics secured an oversubscribed $130 million Series B to move dotinurad toward US and EU commercialization after advancing through late-stage development. The funding supports two...
Organ preservation technology—supercooled kidneys in pigs
Researchers reported that kidneys can be preserved for days using a device that cools organs to -4°C without ice formation, then successfully transplanted into pigs after rewarming. The approach,...
Obesity pipeline advances with retatrutide filings and trial readouts
Eli Lilly pushed retatrutide toward regulatory review after delivering additional Phase 3 obesity wins and shared results on primary endpoints. The company said it plans to file with the FDA early...
FDA approval delivers first payoff for GSK’s $10.6B Nuvalent deal
GSK’s $10.6 billion acquisition of Nuvalent began paying off as the FDA approved zidesamtinib—branded Jideytro—for ROS1-positive metastatic non-small cell lung cancer in patients previously...
Arrowhead advances gene-silencing therapy in hypertriglyceridemia Phase 3
Arrowhead Pharmaceuticals reported positive top-line results from Phase 3 studies of plozasiran (Redemplo) in severe hypertriglyceridemia, setting up a supplemental NDA filing with the FDA before...
Samsung Biologics expands into peptide manufacturing via PolyPeptide acquisition
Samsung Biologics announced an all-cash tender offer of about $1.8 billion to acquire Switzerland-based PolyPeptide Group, a CDMO focused on peptide-based APIs. The proposed transaction would be...
Cell and gene therapy finance and M&A: Repligen buys BioLife Solutions
Repligen moved further into cell-processing services by announcing an acquisition of BioLife Solutions valued around $1.5 billion, aiming to broaden its presence across cell therapy manufacturing...
Biotech funding: Crystalys secures $130M for late-stage gout asset dotinurad
Crystalys Therapeutics raised an oversubscribed $130 million Series B to advance dotinurad, a once-daily oral URAT1 inhibitor for gout, through Phase 3 and commercialization preparation. The...
FDA and trial-risk management: personalized ASOs show seizure reduction in rare SCN2A cases
A UC San Diego-led team reported individualized antisense oligonucleotide (ASO) designs that reduced seizures in two boys with rare SCN2A-related developmental and epileptic encephalopathies and...
Regulatory and policy: U.S. limits on biologics patent “thickets” clear Senate
The U.S. Senate unanimously approved the Affordable Prescriptions for Patients Act (S. 1041), targeting biologics patent thickets by limiting the number of patents a biologics sponsor can assert...
FDA and drug access policy: proposed RPM cut triggers backlash
A Medicare proposal would roll back reimbursement for remote patient monitoring (RPM), prompting concern among companies that provide home monitoring services. The proposal would represent a sharp...
Diagnostic innovation and CE milestone: Cepheid pushes GeneXpert multiplexing while Science gets MDR nod
Cepheid announced an updated third-generation GeneXpert infectious disease PCR platform aimed at faster workflows and higher-plex panels while maintaining compatibility with the current test menu....