New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, including GSK's multiple myeloma treatment Blenrep. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).
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While Accord HealthCare has convinced the European Medicines Agency that its rivaroxaban generic should be approved in the EU, Bayer has warned that patent protection for Xarelto continues until at least late 2023. The EMA this week also recommend approval for a number of other new drugs.
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 sponsors of up to seven new drugs or vaccines will find out this week whether their products will soon be approved in the EU. The products include two vaccines from Sanofi and what is possibly the first generic rival to Bayer's Xarelto to be assessed by the European Medicines Agency.