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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,...
CirCode wins FDA clearance to begin first-in-human circular RNA trial in US
CirCode Biomed received U.S. FDA clearance to start a clinical trial testing a circular RNA therapeutic, the company told Endpoints News. The IND greenlight permits CirCode to evaluate safety and...
Unixell’s iPSC-derived cell therapy gets FDA IND for focal epilepsy
Shanghai Unixell Biotechnology secured FDA IND clearance to test UX-GIP001, an allogeneic iPSC-derived cell therapy for focal epilepsy, the company reported. The Phase I study will evaluate safety...
Akeso secures NMPA go-ahead for trispecific cancer antibody AK-150
Akeso Inc. obtained IND clearance from China’s National Medical Products Administration for AK-150, a first-in-class trispecific antibody targeting advanced solid tumors. The approval authorizes...
NeoGenomics’ PanTracer liquid biopsy wins CMS coverage — reimbursement expands blood-based CGP
NeoGenomics announced that its PanTracer LBx, a blood-based comprehensive genomic profiling test for advanced solid tumors, received CMS coverage. The decision covers the assay for therapy...
Signal Bioscience pushes multiplexed dPCR/qPCR — seed round seeking collaborators
Signal Bioscience unveiled a chemistry that separates nucleic acid amplification from signal generation to boost multiplexing in digital PCR and qPCR and is preparing a seed funding round to...
Unnatural Products raises $45M Series B — macrocycles push toward clinic after Novartis pact
Unnatural Products closed a $45 million Series B to accelerate its macrocyclic peptide platform and advance lead programs toward clinical trials. The round was led by The Venture Collective with...
CytomX partnership frays as Astellas exits — company posts late-line CRC ADC data
Astellas announced it is walking away from a $1.6 billion research and development collaboration with CytomX after six years, while CytomX reported data from its antibody-drug conjugate varsetatug...
Kyron inks research pact with Servier — programmable glycoprotein control moves to collaboration
Kyron Bio signed a research agreement with Servier focused on Kyron’s programmable glycoprotein platform to precisely control therapeutic protein glycosylation. The deal establishes a...