Europa Perspectives—Pan-European Challenges and Solutions Post Brexit
An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).
Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA) was interviewed by Chris Spivey, editorial director, Pharmaceutical Technology® and Biopharmaceutical International®, on Jan. 25, 2024 for the Europa Perspectives series. Thirstrup talks about major recent or ongoing challenges EMA is facing, such as drug shortages, COVID-19, Brexit, and ensuring sufficient skilled staff availability, alongside the solutions being implements to overcome them.
Thirstrup is a medical doctor with a PhD in pharmacology and broad clinical experience in general internal medicine. He has a track record of working with the EU regulatory network. He previously led the Division for Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority and was the Danish member of EMA’s human medicines committee (CHMP). He was also a member of EMA’s Committee for Advanced Therapies (CAT), the chairperson of the CHMP’s Respiratory Drafting Group and co-chair of the European Commission Working Group on Market Access of Biosimilars.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
