Capricor’s Deramiocel Briefing Is a Masterclass in How Not to Define an Endpoint
FDA's July 27 briefing document for Deramiocel (BLA 125842) contradicts Capricor's Phase 3 efficacy claims ahead of tomorrow's AdCom...
Pacira Completes Manufacturing Transition in PCRX-201 Phase 2 Trial
Pacira completes manufacturing transition in PCRX-201 Phase 2 trial without enrollment delays, using commercial process aligned with registration plans.
Akeso Doses First Patient in AK138D1 + Ivonescimab Phase Ib/II Lung Cancer Study
Akeso doses first patient in AK138D1 + ivonescimab Phase Ib/II lung cancer study combining HER3 ADC with PD-1/VEGF bispecific...
Nature Medicine’s 2026 Medical AI Superintelligence Framework Signals What FDA Benchmarking Guidance Has Not Yet Addressed
Nature Medicine's July 2026 AI superintelligence framework exposes a critical gap: FDA has no task-based benchmarking standard for medical...
Oryzon’s iadademstat shows 78% CR rate in AML with TP53, RAS mutations
Oryzon's iadademstat shows 78% CR rate in AML patients with TP53 and RAS mutations, addressing historically treatment-resistant genomic subgroups.
MapLight’s ML-007C-MA Meets Primary Endpoint in Phase 2 Schizophrenia Trial
MapLight's ML-007C-MA met its primary endpoint in Phase 2 schizophrenia trial, showing significant PANSS improvement and cognitive benefits with...
SaaS Platforms Gain Traction in Clinical Trials Despite Spreadsheet Reliance
87% of clinical trial sites use decentralized elements, yet most still rely on spreadsheets. SaaS platforms are closing that...
The Genetic Trial Diversity Problem Is Now a Site Operations Problem
A 99,783-person multi-ancestry Parkinson's study just exposed a critical enrollment gap: GBA1 and LRRK2 trials run almost exclusively in...
NIH Grant Terminations Expose Structural Crisis at Clinical Research Sites
383 NIH-funded clinical trials terminated, exposing structural pressures on research sites managing funding cuts and protocol complexity simultaneously.
The Oral Revolution in Inflammatory Skin Disease: What Povorcitinib’s Phase 3 Design Reveals About the Next Wave of Dermatology Trials
Incyte's STOP-HS1/2 trials (1,227 patients) show how JAK1-selective design and rigorous RCT methodology are reshaping dermatology's clinical trial landscape.