SPARK Just Ran 5,400-Patient Oncology Research Autonomously. Your Trial’s Biomarker Strategy Has Not Caught Up.
SPARK agentic AI validated prognostic biomarkers across 5,400 patients and 18 cancer types—here's what that means for trial enrichment...
The FY2024 BIMO Report Confirms It: Sponsor Oversight Failures Are Now Structural
FDA's FY2024 Bioresearch Monitoring report shows 25% of sponsor inspections drew a Form 483, with the same recurring findings...
Aktis Oncology Initiates Phase 1b Trial of AKY-2519 in mCRPC
Aktis Oncology initiates Phase 1b trial of AKY-2519 in metastatic castration-resistant prostate cancer, targeting B7-H3 expression.
When Gilead Cuts 108 Jobs at Arcellx, Your Trial Feels It Before You Know Why
Gilead's $7.8B Arcellx acquisition just cut 108 Redwood City jobs. Here's what that means for CAR-T trial sites running...
Zentalis Launches ASPENOVA Phase 3 Trial of Azenosertib in Platinum-Resistant Ovarian Cancer
Zentalis launches ASPENOVA Phase 3 trial of azenosertib in platinum-resistant ovarian cancer, targeting Cyclin E1-overexpressing tumors with a dual-track...
Dupixent Improves Esophageal Function in Phase 4 Eosinophilic Esophagitis Trial
Dupixent improves esophageal function in Phase 4 trial, achieving structural changes equivalent to dilation procedures without mechanical intervention.
6.4 Million Patients Can’t Be Wrong — But Can Regulators Read What This Validation Is Actually Saying?
A Nature Medicine validation of PREVENT and SCORE2 across 6.4M individuals offers a blueprint for RWE methodology that FDA...
Cellectar’s Iopofosine Meets FDA Durability Requirements in Waldenström Study
Cellectar's iopofosine meets FDA durability requirements in Waldenström study with 83.6% ORR and 17.8-month median response duration.
Nanobiotix Amends NANORAY-312 Trial Design, Eliminates Interim Analysis
Johnson & Johnson amends NANORAY-312 trial design, eliminating interim analysis and accelerating the final efficacy readout in head and...
Ersodetug Shows Strong Hypoglycemia Reductions in Congenital Hyperinsulinism Trial
Ersodetug shows 50-80% reductions in hypoglycemia time in congenital hyperinsulinism trial, with strong patient retention in open-label extension.