Professor Guido Rasi’s last day as Executive Director of EMA comes in the middle of one of the biggest public health emergencies of the past century. “We are seeing an unprecedented effort…to tackle the pandemic. The number of therapeutics and vaccines that are currently under development is encouraging, and information on the initial results from clinical trials on vaccines is starting to be reported by the pharmaceutical industry. In the words of one developer, ‘we are a significant step closer’ to a vaccine.”
He emphasized the importance of the role that regulators would be playing in reviewing the available data packages. “EMA will ensure that the scientific review is conducted as rapidly as possible. This is a vitally important step as the time spent in conducting the review will not only ensure that our stringent regulatory standards are met but will also serve to reinforce public confidence in the vaccines.”
His successor, Emer Cooke, he describes as, “a strong leader who is committed to steering EMA during this very challenging period and ensuring that the Agency’s work on COVID-19-related activities continues uninterrupted.” And that What is needed now is, “a reinforcement of EMA’s resources so that it can continue to deliver on its core business, deliver on the joint EMA/Heads of Medicines Agencies strategy…to address future challenges and undertake the additional activities to fulfil its new mandate.”
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In 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.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.