FDA Lifts Clinical Hold on Simufilam for TSC-Related Epilepsy Study
FDA lifts clinical hold on simufilam, enabling Filana to start Phase 2a proof-of-concept study in TSC-related epilepsy after nine-month...
Risk-Based Source Data Verification Adoption Rises to 96% in Clinical Trials
Risk-based source data verification adoption reaches 96% in clinical trials, reshaping how monitors prioritize verification intensity across sites and...
Merry Life Biomedical Starts Phase 2 Trial of TML-6 for Early Alzheimer’s
Merry Life Biomedical starts Phase 2 trial of TML-6, an oral drug targeting autophagy-lysosomal pathways in early Alzheimer's disease...
Ivonescimab beats durvalumab in biliary tract cancer Phase III trial
Ivonescimab plus chemotherapy achieved a statistically significant overall survival benefit over durvalumab in biliary tract cancer Phase III trial...
EC Approves Obicetrapib as Oral CETP Inhibitor for Hypercholesterolemia
European Commission approves obicetrapib, a CETP inhibitor for hypercholesterolemia, offering oral dosing and 41% LDL-C reduction in Phase 3...
Roche’s Enicepatide Meets Phase II Endpoints in Type 2 Diabetes Trial
Roche's enicepatide met Phase II endpoints in type 2 diabetes trial, demonstrating dose-dependent reductions in HbA1c and body weight...
FDA Part 11 Compliance: Audit Trails and Electronic Signatures
FDA Part 11 Compliance requires validated systems, audit trails, and electronic signatures linked to individual users. Learn what triggers...
Phase III Clinical Trials Now Generate 5.9M Data Points Annually, Growing 11% Yearly
Phase III Clinical Trials now generate 5.9M data points annually with 11% yearly growth, raising questions about managing protocol...
Wearable neuromodulation reduces AF recurrence after ablation in pilot trial
Wearable neuromodulation reduces AF recurrence after ablation in pilot trial, with 90% freedom from arrhythmias at six months versus...
Accro Bioscience Doses First Patient in AC-101 Phase IIb Trial for Ulcerative Colitis
Accro Bioscience doses first patient in AC-101 Phase IIb trial for ulcerative colitis, targeting the NOD/RIPK2 pathway with a...