Health care and medicines are among the priorities outlined by the new presidency of the Council of the EU for the first half of 2023.
Sweden, which took over the rotating presidency of the Council of the European Union on 1 January, says it will prioritize a number of health-related initiatives in the first half of the year, including the revision of the EU pharmaceutical legislation, revisions to the regulations on orphan and pediatric medicines, and a new fee structure for the European Medicines Agency.
The presidency said it would also make efforts to keep the issue of antimicrobial resistance “at the top of the...
Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.
