Three regulatory guidelines converge on risk-based quality management for clinical trials
ICH E6(R3), E8(R1), and MHRA guidance now align on risk-based quality management for clinical trials, requiring sponsors to update...
FDA’s AI Risk-Based Guidance Shifts Validation Burden to Sponsors
FDA's AI Risk-Based Guidance shifts validation burden to sponsors, requiring documented credibility assessments before deploying AI in clinical trials.
Lundbeck presents MSA trial baseline data, Lu AF28996 Phase Ib results at MDS 2026
Lundbeck presents baseline enrollment data from Phase III MASCOT trial of amlenetug for multiple system atrophy, with efficacy results...
Nektar Discloses Phase 2b Data for REZPEG in Severe Alopecia Areata
Nektar disclosed Phase 2b data for REZPEG in severe alopecia areata, testing a regulatory T-cell stimulation approach against existing...
Monte Rosa’s MRT-8102 shows NLRP3 inflammasome activity normalization in Phase 1 study
Monte Rosa's MRT-8102 shows NLRP3 inflammasome activity normalization in Phase 1 study of 108 obese participants with elevated cardiovascular...
Survodutide delivers 13.1% weight loss in Phase III trial for obesity and type 2 diabetes
Survodutide delivers 13.1% weight loss in Phase III trial for obesity and type 2 diabetes, with significant glycemic improvements...
Your IP Is Sitting in a Freezer Somewhere, And Your CRA Doesn’t Know Where
Decentralized supply management is breaking traditional cold-chain oversight. Here's what DSM failures cost sites in enrollment ramp and budget...
The VIRAGE Trial Cracked the Pancreatic Cancer Wall. Now the Hard Question Is Whether the Field Can Read the Blueprint.
VCN-01 plus gemcitabine/nab-paclitaxel improved OS in metastatic pancreatic cancer. The VIRAGE Phase 2b design shows what rigorous endpoint selection...
Clinical Trials Struggle to Recruit Undiagnosed Patients Without Diagnostic Coverage
Clinical trials recruit faces barriers when patients lack diagnoses. Diagnostic coverage gaps exclude 25M Americans from research participation.
EP-104GI Maintains 64% Remission Rate at 52 Weeks in Eosinophilic Esophagitis Trial
EP-104GI maintains 64% remission rate at 52 weeks in eosinophilic esophagitis trial, offering a single-procedure alternative to daily therapy.