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...
Extension Studies Are Not Optional Data, They’re the FDA’s Long-Term Safety Net
JAMA's new analysis shows extension studies catch delayed adverse events and durability gaps that Phase 3 trials structurally cannot,...
QIAGEN Selects Medrio EDC for In Vitro Diagnostic Studies
QIAGEN selects Medrio EDC to streamline in vitro diagnostic studies with cost control and internal form configuration capabilities.
Icotrokinra meets ACR20 endpoint in Phase 3 psoriatic arthritis trial
Icotrokinra meets ACR20 endpoint in Phase 3 psoriatic arthritis trial, with 58% of biologic-naive patients achieving response at Week...
The FDA’s AAV Approval Playbook Has Gaps That Could Define the Next Decade of Gene Therapy
FDA's reviews of Zolgensma, Luxturna, and Hemgenix reveal critical gaps in AAV trial design, CMC standards, and long-term safety...