Helus Pharma Supports Psychedelic Research Executive Order
The White House issued an Executive Order aimed at accelerating development and access for psychedelic-based treatments, outlining potential prioritization...
FDA Fast Tracks bbot’s Promising KRAS Pancreatic Cancer Drug
In early Phase 1 dose escalation, BBOT’s pan-KRAS inhibitor BBO-11818 produced a confirmed partial response in pancreatic ductal adenocarcinoma...
Orion’s ODM-212 Granted Orphan Drug Status for Mesothelioma
Orion Pharma has secured US FDA Orphan Drug Designation for ODM-212 in mesothelioma, adding regulatory leverage to a first-in-class...
Atsena to Advance Pivotal Trial for X-Linked Retinoschisis
An independent data monitoring review of Parts A and B of Atsena Therapeutics’ LIGHTHOUSE study found ATSN-201 safe and...
EU Clinical Trials Face Cost, Speed, and China Competition Pressure
At the Clinical Trial Innovation Summit 2025 in Basel, industry leaders from UCB, Novo Nordisk, Novartis, and Medable debated...
How LLMs Can Audit LSD Clinical Trial Ratings in Real Time
MindMed is running three phase three trials of pharmaceutically optimized LSD with a two-person AI team and a custom...
AI Platform Predicts Clinical Trial Outcomes with High Accuracy
At the Clinical Trial Innovation Summit 2025 in Basel, QuantHealth's Chief Medical Officer presented AI-driven trial simulation technology capable...
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...
MST Matches ECT Efficacy—and Leaves Memory Intact. The CREST-MST Trial Just Changed the Convulsive Therapy Conversation
The CREST-MST trial in Lancet Psychiatry shows magnetic seizure therapy matches ECT remission rates in TRD with a superior...
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 —...