Addressing Current Regulatory Challenges with Diversity in Clinical Trials
March 31st 2025In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses how the current political climate is affecting diversity in clinical research and how diversity action plans may be impacted.
FOCUS Trial Results Show Solriamfetol Significantly Reduces ADHD Symptoms, Severity in Adults
March 27th 2025Solriamfetol achieved the primary and key secondary endpoint of the Phase III FOCUS trial by significantly lowering attention-deficit hyperactivity disorder symptoms and disease severity in adults compared to placebo, with a favorable safety and tolerability profile.
Medable Eyes Expanded Presence in Europe with New Approval for Digital Trials
March 25th 2025Andrew Mackinnon, Executive GM, Medable, explains how the company’s recent approval in France could support the expansion of digital and decentralized clinical trials across Europe, particularly through enhanced e-consent practices.
VERITAC-2 Trial Shows Vepdegestrant Significantly Improves Survival in ESR1-Mutant Breast Cancer
March 24th 2025Phase III VERITAC-2 trial results show vepdegestrant significantly improved progression-free survivalcompared to fulvestrant in patients with ESR1-mutant (ESR1m) advanced or metastatic breast cancer, but did not achieve statistical significance in the overall intent-to-treat population.
Phase II DAHLIAS Trial Results Lead to Fast Track Designation for Nipocalimab for Sjögren’s Disease
March 18th 2025FDA grants Fast Track designation to Johnson & Johnson’s investigational therapy nipocalimab for the treatment of moderate-to-severe Sjögren’s disease, which could be the first FcRn blocker ever approved for the autoimmune condition.
MIRASOL Trial Shows Elahere Significantly Improves Survival in Platinum-Resistant Ovarian Cancer
March 17th 2025In the Phase III MIRASOL trial, Elahere (mirvetuximab soravtansine-gynx) significantly improved progression-free survival and overall survival compared to chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer.