Why Pharma’s AI Future Depends on Standardization First
At its annual Summit, Veeva unveiled a flat-rate pricing model for Vault AI, introduced Falcon agentic labor tools, and...
FDA AI Guidance Requires Sponsors to Validate Clinical Trial Algorithms
FDA AI Guidance requires clinical trial sponsors to validate algorithms before submission, shifting documentation and testing burdens based on...
NFL funds $500K study into elevated ALS risk in athletes, veterans, first responders
NFL funds $500K study into elevated ALS risk in athletes, veterans, and first responders to identify genetic and biological...
Hengrui Pharma presents 64 studies at ESMO 2026, including Phase 3 ruzaltatug data
Hengrui Pharma presents Phase 3 ruzaltatug data at ESMO 2026, showing progression-free survival endpoint met in EGFR-mutated NSCLC after...
Odyssey’s OD-001 Hits Primary Endpoint in Phase 2a Ulcerative Colitis Study
OD-001 Phase 2a ulcerative colitis study hits primary endpoint with 2.4-point modified Mayo score reduction at Week 12, supporting...
RAP-219 hits primary endpoint in Phase 2 bipolar mania trial
RAP-219 hits primary endpoint in Phase 2 bipolar mania trial with statistically significant 3.1-point placebo-adjusted improvement on YMRS at...
AI Is Flooding Drug Discovery With Candidates. Clinical Validation Has No Flood Gates.
AI can generate 100x more drug candidates, but trials still need real patients. The bottleneck has shifted, and most...
Research Billing Is a False Claims Act Surface. Treat the MCA Like the Control It Is.
A stale or vague Medical Coverage Analysis is worse than none when an auditor arrives. Here is why the...
The Dystrophin Standard: How a 1% Biomarker Signal Became a $967 Million Accelerated Approval Precedent
FDA granted four DMD antisense oligonucleotide accelerated approvals on ~1 percentage-point dystrophin increases. With $967M in annual revenue on...
Icotrokinra’s NEJM Data Reveals the Quiet Shift in How UC Trials Get Designed and Approved
J&J's icotrokinra hit every UC endpoint in NEJM's Oct 2026 data, and the trial design choices behind that success...