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News
Iza-bren 2.5 mg/kg dose advances to Phase 3 in EGFR-mutated NSCLC
1+ day, 11+ hour ago (362+ words) clinicaltrialvanguard.com Iza-bren 2.5 mg/kg dose advances to Phase 3 in EGFR-mutated NSCLC Three dose levels entered a randomized expansion cohort; only one came out with a Phase 3 ticket. SystImmune and Bristol Myers Squibb will present at WCLC in Seoul on…...
PSI CRO to Present Agile Models for Emerging Biotech at OCT New England
4+ day, 11+ hour ago (314+ words) The Clinical Trial Vanguard PSI CRO to Present Agile Models for Emerging Biotech at OCT New England Ninety-three percent repeat business and 15% revenue growth in a single year puts PSI CRO in an unusual position for a mid-size CRO: sponsors…...
Insilico Medicine Begins Phase III Trial of AI-Discovered Drug Rentosertib for IPF
4+ day, 11+ hour ago (422+ words) The Clinical Trial Vanguard Insilico Medicine Begins Phase III Trial of AI-Discovered Drug Rentosertib for IPF Rentosertib just cleared a threshold no AI-discovered drug has reached before: 320 patients, 47 sites, 52 weeks of treatment in a randomized, double-blind, placebo-controlled Phase III. Insilico Medicine…...
Novartis Pays $50M Milestone as MRT-6160 Enters Phase 2 for Sjögren’s Disease
5+ day, 11+ hour ago (336+ words) The Clinical Trial Vanguard Novartis Pays $50M Milestone as MRT-6160 Enters Phase 2 for Sjögren’s Disease A $50 million check is the clearest signal yet that Novartis believes VAV1 degradation works in humans. Monte Rosa Therapeutics triggered that milestone payment on September 8, 2026, when Novartis…...
Mosliciguat Advances to Phase 3 PHrontier Trial After PHocus Study Shows 20% PVR Reduction
5+ day, 11+ hour ago (368+ words) The Clinical Trial Vanguard Mosliciguat Advances to Phase 3 PHrontier Trial After PHocus Study Shows 20% PVR Reduction Mosliciguat cut pulmonary vascular resistance by 20 percent in Roivant’s Phase 2 PHocus trial, a result that now sends the once-daily inhaled drug directly into a…...
Clinical trial sites advised to build data infrastructure before deploying AI tools
6+ day, 11+ hour ago (459+ words) clinicaltrialvanguard.com Clinical trial sites advised to build data infrastructure before deploying AI tools About three-quarters of clinical trial sites now use eSource in active studies, according to a 2024 RealTime Reports survey, yet the panel that CRIO and Clinical Leader…...
Tekton Research Sites Enroll 60 Participants in Phase 2 Obesity Trial, Triple Goal
1+ week, 11+ hour ago (334+ words) The Clinical Trial Vanguard Tekton Research Sites Enroll 60 Participants in Phase 2 Obesity Trial, Triple Goal Enrolling three times the planned number of participants is rare enough that it usually points to something structural, not just enthusiasm. Tekton Research’s San Antonio…...
AI Agents in Clinical Trials Require Human Review Before Data Commits
1+ week, 2+ day ago (423+ words) The Clinical Trial Vanguard AI Agents in Clinical Trials Require Human Review Before Data Commits A phase 3 protocol in 2020 collected an average of 3.56 million data points. By 2025 that number had climbed to 5.96 million, a 67% rise in five years and more…...
Ultragenyx’s apazunersen fails Phase 3 primary endpoint in Angelman syndrome
1+ week, 4+ day ago (527+ words) The Clinical Trial Vanguard Ultragenyx’s apazunersen fails Phase 3 primary endpoint in Angelman syndrome Two years of Phase 1/2 momentum collapsed in a single readout: Ultragenyx’s Phase 3 Aspire study for apazunersen (GTX-102) in Angelman syndrome failed both its primary endpoint and its…...
WCG releases checklist to speed protocol amendment implementation at clinical trial sites
1+ week, 4+ day ago (486+ words) The Clinical Trial Vanguard WCG releases checklist to speed protocol amendment implementation at clinical trial sites Three-point-three amendments per protocol, on average, across trials that get amended at all, and 76% of trials now require at least one, up from 57% in…...