Novartis Restructures Clinical Ops to Scale Trial Innovation Beyond Pilots
Novartis built a dedicated Global Clinical Operations Innovation Team 18 months ago to move past one-off pilots and embed...
Moe Alsumidaie
The ICU Trial That Should Embarrass Every Sponsor Hiding Behind “Ethical Complexity”
A JAMA RCT on ICU restraint strategies just proved rigorous trial design works even in critically ill patients —...
Ewing Sarcoma’s EWS::FLI1 Trial Just Showed What Precision Oncology Has Been Promising for a Decade
A Nature Medicine phase 1/2 trial of trabectedin plus low-dose irinotecan targeting EWS::FLI1 in Ewing sarcoma signals a new...
The Imaging Gap in GLP-1 Trials: Why the Most Important Data May Not Be in Your Protocol
Professor Mikael Boesen Professor of Musculoskeletal Radiology & Head of Imaging Research, Copenhagen University Hospital Bispebjerg and Frederiksberg A...
The MASAI Trial Just Made AI-Augmented Mammography the Standard of Care. The FDA Hasn’t Noticed
The MASAI trial showed AI-plus-one-radiologist outperforms two radiologists in breast cancer screening. FDA's AI device framework still treats this...
The Liver Signal Europe Just Sent About Cenobamate Will Reshape How Sponsors Design Post-Approval Safety Plans
The EMA's PRAC issued a direct communication to healthcare professionals about severe liver injury linked to cenobamate in April...
France Approved IV Ketamine for Suicidal Crisis. The FDA Should Be Uncomfortable Right Now.
France's March 2026 authorization of intravenous racemic ketamine for acute suicidal crisis is the first regulatory approval of its...
MRD Is Now the Endpoint That Matters: The EMN24 IsKia Trial Just Proved It
The EMN24 IsKia phase 3 trial didn't just test a new drug combination for newly diagnosed multiple myeloma —...
The Basket Trial Is the New Black — and the FDA Hasn’t Caught Up
Arrowhead Pharmaceuticals' Phase 1 basket trial of zodasiran enrolled five distinct lipid disorder populations under a single protocol —...
The FDA Just Opened a Door in Anal Cancer Trials — And Most Sponsors Don’t Know It’s There
Oncolytics Biotech's Type C meeting request to discuss a single-arm registrational pathway for pelareorep in anal cancer is more...