Latest From Maureen Kenny
The loss of fast-track status for setmelanotide at the European Medicines Agency means the review of the potential treatment of two rare genetic disorders of obesity will take longer than Rhythm Pharmaceuticals had originally hoped.
Swiss company Santhera's lengthy and problem-laden journey to repurpose its already marketed idebenone for use in Duchenne Muscular Dystrophy has ended in failure. The company has withdrawn its EU filing for the product following its announcement that it was halting development.
Novartis seems to have accepted the fact that the indication granted for Piqray in the EU means there is little scope for the advanced breast cancer drug to be used in markets such as the UK.
Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
Change in leadership at the European Medicines Agency comes at a critical time.
The change in leadership at the European Medicines Agency comes at a critical time.