Another three marketing authorization applications will be fast-tracked through the centralized review process at the European Medicines Agency. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.

Akcea Therapeutics has lowered its asking price in England for its antisense therapy for familial chylomicronaemia syndrome. It has also struck a pricing and reimbursement deal for the drug in Germany.

The RNA-drug developer, which is buying the approximately 24% of Akcea it doesn't already own for around $500m, highlighted the maturing pipeline in a cardiovascular overview.

With just 10 user fee goal dates coming up, September could be break from the fast pace of FDA decisions over the summer.