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Personalized mRNA oncology delivers first randomized Phase 3 signal
Merck and Moderna reported positive results from a Phase 3 trial testing their personalized mRNA cancer vaccine, intismeran autogene, in adjuvant melanoma. The program combines intismeran...
Regeneron secures FDA nod for ultra-rare fibrodysplasia ossificans progressiva
The FDA approved Regeneron’s activin A-targeting antibody garetosmab, branded Pasatru, for adults with fibrodysplasia ossificans progressiva (FOP). The decision gives patients a second...
Gene therapy manufacturing bottleneck spotlights need to separate full and empty AAV
Researchers flagged viral-vector purification as an urgent gene-therapy bottleneck, arguing that current downstream processes struggle to reliably distinguish full, gene-loaded AAV capsids from...
New cell-therapy analytics automation targets high-throughput auditing at small volumes
BlueRock Therapeutics said it has built an automated system for high-throughput auditing of cell therapies, designed to work with small sample volumes and the workflows typical in cell...
Court ruling upholds Parse Biosciences win in patent dispute over 10x Genomics
A US appeals court upheld a decision siding with Parse Biosciences in a patent dispute against 10x Genomics. The US Court of Appeals for the Federal Circuit affirmed invalidation of three...
New FDA pick signals next chapter for agency leadership
President Donald Trump announced Heidi Overton as his pick for FDA commissioner, setting up a leadership change for the US drug regulator. Multiple reports and the administration’s announcement...
Network Bio launches cfRNA foundation model program with Nvidia
Network Bio launched with $50 million in financing and announced a $30 million collaboration with Nvidia to build a cell-free RNA (cfRNA) foundation model for biomedical discovery. The startup...
BioMarin expands rare bone pipeline by acquiring Alesta’s ALE-1
BioMarin agreed to acquire Alesta Therapeutics in a deal that totals $275 million upfront and up to $490 million including milestones for Alesta’s lead oral small-molecule candidate ALE-1. ALE-1...
Craif scales US push for urine-based pancreatic cancer screening test
Craif, a Nagoya University spinout, raised $33 million in a Series D round and is scaling toward US clinical evaluation of its urine-based pancreatic cancer test. The company plans to expand its...
Startup Snipr reports first positive patient signal for CRISPR-modified phage SNIPR-001
Snipr Biome reported first patient data indicating a positive effect from SNIPR-001, a CRISPR-modified bacteriophage targeting antibiotic-resistant Escherichia coli. The data were described as...
personalized mRNA vaccines in late-stage oncology
Merck and Moderna reported Phase 3 success for their personalized neoantigen mRNA cancer vaccine, intismeran autogene, delivering randomized evidence of benefit in a late-stage melanoma setting....
FDA leadership shakeup and regulatory outlook
Multiple reports say President Donald Trump plans to nominate Heidi Overton to lead the U.S. Food and Drug Administration, a move that would end the agency’s extended stretch without a permanent...
post-bariatric hypoglycemia enters late-stage GLP-1 antagonist era
Amylyx reported Phase 3 success for avexitide, a GLP-1 receptor antagonist intended for post-bariatric hypoglycemia (PBH), showing a substantial reduction in serious hypoglycemic events versus...
liquid biopsy scaling in Japan for lung cancer screening
Pillar Biosciences said it will supply its oncoReveal Essential+ sequencing assay to a Japan-based liquid biopsy program under LC-SCRUM-Asia, aimed at profiling cfDNA and cfRNA from approximately...
urine-based pancreatic cancer screening moves toward US trial buildout
Craif raised $33 million in a Series D financing to accelerate its entry into the U.S., with a near-term plan to generate clinical evidence for a urine-based pancreatic cancer test backed by...
AI infrastructure for cell-free RNA foundations
Network Bio launched with $50 million in financing and announced a collaboration valued at $30 million with Nvidia to develop a cell-free RNA (cfRNA) foundation model. The partnership aims to...
STING-adjuvanted mRNA vaccines sharpen antitumor immunity
Two related reports describe mRNA vaccine strategies that improve antitumor immunity by changing how STING signaling is timed and activated. In Nature Biotechnology, a synchronized approach...
sequencing platform and AI diagnostics expansion in biopharma workflows
Oxford Nanopore laid out a business roadmap aimed at increasing adoption of its sequencing technology across biopharma, clinical, and research end markets. In a call covering 2026 half-year...
amylin analog/GLP-1 race focuses on design differentiation
A key competitive thread in the amylin analog market intensified as drug design differentiation came into focus around near-term mid-stage weight loss readouts. The amylin race is being shaped by...
CD4 cytotoxic T lymphocytes and immune adaptations in extreme longevity
A new study from the University of Osaka, reported across Cell Reports and follow-on reporting, links extreme longevity to an adaptive expansion of a rare immune subset: CD4 cytotoxic T...