ICH E6(R3) Raises the Bar on Imaging in Clinical Trials—Are You Ready?
When the FDA inspector arrived, no one expected imaging to be the issue. The scans had been read. The...
New Vascepa Data Shows Reduced CVD Risk, Hospitalizations
Among REDUCE-IT participants with cardiovascular-kidney-metabolic (CKM) syndrome and baseline eGFR below 60 mL/min/1.73m2, icosapent ethyl cut time to first...
Cytokinetics Reveals New MAPLE-HCM Data at ESC Congress 2025
Aficamten improved peak oxygen uptake by a mean of 1.1 mL/kg/min at 24 weeks, while metoprolol declined by 1.2...
Interim Data for Pediatric HCM from Tenaya’s MyCLIMB Study
Interim data from Tenaya’s MyClimb natural history study of MYBPC3-associated pediatric HCM reported a 93% prevalence of nonobstructive disease...
Upstream Bio to Report Verekitug Phase 2 Top-Line Data
Upstream Bio will release top-line results tomorrow from VIBRANT, its global, randomized, placebo-controlled Phase 2 trial of verekitug in...
Oculis Presents Trial Data on Macular Edema, Optic Neuritis
Phase 2 ACUITY data for Privosegtor (OCS-05) in acute optic neuritis show improvements in low-contrast visual acuity along with...
What Clinical Trial Venture Capital Think About Clinical Trial Tech
“Even when the ROI is 10 to 13x, it still takes six years to adopt.” That’s the paradox that...
Pharma Cuts Clinical Trial CSR Time by >50% With AI
AI is revolutionizing clinical documentation in clinical trials. In this interview, Anita Modi, CEO and Founder of Peer AI,...
Cancer Drug Destiny: Bicycle Toxin Conjugate Trial Report
No quantitative efficacy data were disclosed; however, a new industry report highlights early Phase 1/2 signals for bicycle toxin...
Medicinova Completes COMBAT-ALS Trial Enrollment
MediciNova has completed enrollment in its Phase 2b/3 COMBAT-ALS trial of MN-166 (ibudilast) for amyotrophic lateral sclerosis (ALS). The...