EU

DDW’s Diana Spencer explores the European Commission’s proposed changes to EU pharmaceutical legislation, the reaction from industry and possible impact on smaller companies. The European Commission (EC) has proposed the largest reform to the EU’s pharmaceutical legislation in over 20 years. The EC says the revisions will make the system more agile, flexible, and adapted to the needs […]

New EU legislation designed to improve public health is delaying clinical trials and blocking access to new treatments for cancer and rare diseases, says the European Federation of Pharmaceutical Industries and Associations (EFPIA). The number of clinical trials delayed is expected to run into the hundreds, affecting up to 42,200 patients over the next three […]

Pierre Fabre will commercialise and distribute the first approved allogeneic T cell immunotherapy in Europe following the transfer of the European Commission marketing authorisation of Ebvallo (tabelecleucel) from Atara Biotherapeutics.  Ebvallo is the only approved therapy for the treatment of relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) in the EU.  Pierre […]

Dr Julie Warner is Vice President of Regulatory Affairs at global drug development consultancy, Boyds. In this article, she provides her expert insights into the key regulatory developments likely to shape the global drug development industry this year.    Implementation of the EU Clinical Trials Regulation  The way clinical trials (CTs) are conducted in the European […]

The UK government has announced its future strategy for batch testing of medicinal products.  The new strategy means that the UK will continue to recognise batch testing from the EU/EEA, rather than insisting on duplicative batch testing operations.  Post-BREXIT, the pharmaceutical industry urged the UK and the EU to sign a Mutual Recognition Agreement (MRA) […]

With European life sciences R&D investment at a 20-year low, biopharmaceutical associations and MEPs are calling on the EU to modernise its policies. DDW’s Diana Spencer asks what will be needed for Europe to compete in the growing global market for advanced therapies.  A new report by Charles River Associates for the European Federation of […]