REMS Challenges Discussed

Updated GLISTEN trial results presented at EASL 2025 confirm that the IBAT inhibitor linerixibat significantly improved worst itch scores and itch-related sleep interference over 24 weeks in adults with primary biliary cholangitis.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

The JADE study will be evaluating BI 1584862, an investigational oral compound that targets inflammation and preserves vascular function.

Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.

Topline results from the Phase III DESTINY-Breast11 trial show that Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab, and pertuzumab significantly improves pathologic complete response rates compared to anthracycline-based standard-of-care regimens in the neoadjuvant treatment of high-risk, locally advanced HER2-positive early-stage breast cancer.