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Overcoming hurdles with licensing complexities, post-production changes, and IRB submissions can help in reducing timelines and increasing collaboration.

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.

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.

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

Updated results from the Phase III ELATIVE trial reveal Iqirvo (elafibranor) significantly reduced fatigue in patients with primary biliary cholangitis, with effects independent of pruritus and supported by proteomic data.