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CytomX masked ADC shows responses in late‑line colorectal — shares rally
CytomX released expansion‑cohort results for its masked, conditionally activated antibody‑drug conjugate Varseta‑M in late‑line metastatic colorectal cancer, reporting response rates between 20%...
BioMarin halts Voxzogo dosing after hip‑related safety signal
BioMarin announced it will stop dosing certain patients in two mid‑stage trials of Voxzogo following reports of slipped capital femoral epiphysis (SCFE) in independent studies. The company flagged...
ARPA‑H backs AI‑led gene‑therapy manufacturing platform — $9.3M award
ARPA‑H awarded BioCurie up to $9.3 million to develop an AI‑driven, scalable manufacturing platform for viral and non‑viral gene therapies. The program will integrate machine learning,...
Trenchant, Invetech partner to commercialize fully automated CGT platform
Trenchant BioSystems struck an engineering and development collaboration with Invetech to advance its AutoCell platform toward commercialization, targeting fully automated, point‑of‑care cell and...
Illumina and Veritas launch preventive genomics consortium — WGS enters care
Illumina and Veritas Genetics have formed a preventive genomics consortium to bring whole‑genome sequencing into proactive healthcare, offering an opt‑in program that combines Illumina’s...
CirCode clears FDA to test circular RNA therapy in U.S. trial
CirCode Biomed received FDA clearance to begin a U.S. clinical trial of its circular RNA therapeutic, marking a first test of the circular RNA modality in the American regulatory environment. The...
Unixell gains FDA IND for iPSC‑derived allogeneic cell therapy in epilepsy
Shanghai‑based Unixell Biotech received FDA clearance to start a Phase 1 trial of UX‑GIP001, an iPSC‑derived, allogeneic cell therapy for focal epilepsy resistant to drugs. The first‑in‑human...
Roche inks Nvidia deal to accelerate AI drug and diagnostic factory
Roche announced an expanded partnership with Nvidia to bolster its AI 'factory' for drug and diagnostic development, aiming to accelerate model training, molecular design, and diagnostic pipelines...
Structure’s oral GLP-1 rivals injectables — 16% weight loss in Phase 2
Structure Therapeutics reported mid-stage results showing its oral GLP-1 candidate aleniglipron produced an average ~16% body-weight reduction at 44 weeks, a magnitude that approaches injectable...
Federal judge freezes Kennedy vaccine overhaul — CDC changes blocked
A U.S. district judge issued a temporary block on major elements of Health Secretary Robert F. Kennedy Jr.'s overhaul of federal childhood vaccine policy, staying the CDC's decision to reduce...
CytomX posts ADC responses; partner pulls out of T-cell engager pact
CytomX Therapeutics released Phase 1 expansion data showing its masked antibody‑drug conjugate Varseta‑M achieved 20–32% response rates in heavily pretreated colorectal cancer cohorts and extended...
BioMarin pauses Voxzogo dosing after hip safety signal
BioMarin announced a dosing pause for subsets of patients in two Phase 2 trials of Voxzogo after independent studies flagged hip‑related adverse events—specifically cases of slipped capital...
ARPA‑H funds BioCurie to build AI‑driven gene therapy manufacturing platform
ARPA‑H awarded BioCurie up to $9.3 million to develop an AI‑powered digital platform aimed at accelerating and de‑risking gene therapy manufacturing. The grant funds computational modeling,...
Trenchant, Invetech race to automate point‑of‑care CGT manufacturing
Trenchant BioSystems and engineering partner Invetech announced a collaboration to finalize and commercialize the AutoCell platform, a fully automated cell‑and‑gene therapy (CGT) manufacturing...
CMIC integrates agentic AI to speed regulatory trial documentation
Japan’s CRO CMIC partnered with Bluenote to deploy agentic AI across protocol development, statistical planning and study reports, aiming to accelerate regulatory documentation by up to 75% per...
Illumina, Veritas launch preventive genomics consortium — WGS into care
Illumina and Veritas Genetics announced a consortium to integrate whole‑genome sequencing (WGS) into preventive healthcare, combining Illumina’s sequencing and DRAGEN analysis with Veritas’...
CirCode wins FDA clearance to test circular RNA therapy in the US
CirCode Biomed secured U.S. FDA clearance to begin a clinical trial testing its circular RNA therapeutic platform, marking a notable regulatory green light for an emerging genetic‑medicine...
CMS covers NeoGenomics PanTracer LBx — liquid biopsy gets reimbursed
Centers for Medicare & Medicaid Services granted coverage for NeoGenomics’ PanTracer LBx blood‑based comprehensive genomic profiling test for advanced solid tumors, potentially widening access to...
Structure’s oral GLP-1 pill posts strong midstage results — dosing tweak steadies tolerability
Structure Therapeutics reported Phase 2 efficacy and tolerability data for its oral GLP-1 candidate aleniglipron showing pronounced weight loss and improved retention. In a trial of 61 treated...
Illumina and Veritas launch preventive genomics consortium — WGS moves upstream
Illumina and Veritas Genetics announced a consortium to integrate whole-genome sequencing into preventive healthcare pathways across the U.S. and other markets. Illumina will bring sequencing,...