New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include six new products, including Leqvio, Novartis's treatment for adults with hypercholesterolemia or mixed dyslipidemia. 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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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include six new products, including bluebird bio's Skysona, the first gene therapy approved in the EU to treat early cerebral adrenoleukodystrophy.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Bavencio, Taltz, Cosentyx, and Opdivo plus Yervoy were this week also the subject of final recommendations from the health technology assessment body, NICE, on whether or not they should be used on the National Health Service for certain indications.