FDA Would Rather You Relaxed the P-Value Than Dropped the Control Arm
At a Duke-Margolis and FDA workshop on rare disease statistics, an agency statistician made the trade-off explicit: a randomized...
Werewolf’s WTX-330 Shows Partial Response in Early Cancer Trial
Werewolf's WTX-330 shows partial response in early cancer trial, demonstrating manageable tolerability across dose escalation in Phase 1b/2 testing.
Faeth’s PIKTOR shows 33% response rate in pretreated endometrial cancer
Faeth's PIKTOR combination achieved a 33% response rate in heavily pretreated endometrial cancer patients with PI3K pathway mutations.
Vir’s elebsiran-tobevibart combo hits Phase 3 goal in hepatitis delta
Vir's elebsiran-tobevibart combo achieves Phase 3 primary endpoint in hepatitis delta, with 44% reaching undetectable virus and normal ALT...
The 45-Minute Study Build and Sanofi’s Push to Automate Clinical Trials
Ray Letulle built a study from a protocol in 45 minutes on stage in Boston. The Veeva R&D and...
The Checkpoint Combination Trap: Why Oncology Trials Keep Winning Battles the FDA Doesn’t Care About
Checkpoint inhibitor combos are dominating oncology pipelines, but a structural gap between trial design and FDA approval pathways is...
AI Automation Reshapes Clinical Data Management as EDC Market Grows
AI automation is transforming clinical data management as the EDC market grows to $7.1B by 2030, reshaping how trial...
Tafolecimab cuts LDL-C over 65% as monotherapy in Phase 3 trial
Tafolecimab cuts LDL-C over 65% as monotherapy in Phase 3 trial, offering a statin-free option for hypercholesterolemia patients.
Pasritamig plus JNJ-9401 achieves 73% PSA response in metastatic prostate cancer
Pasritamig plus JNJ-9401 produced PSA reductions of at least 50% in 73% of heavily pretreated metastatic prostate cancer patients...
Psychedelic Trials Need Better Blinding: What UMBRAA Could Contribute
A JAMA Psychiatry Viewpoint proposes UMBRAA: multidrug active placebos plus authorized incomplete disclosure. It is untested, but the problem...