New EU Approvals
Executive Summary
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Vyepti, Lundbeck’s drug for the prophylaxis of migraine.
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European Countries Step Up Efforts To Tackle Monkeypox
The UK says a “proportionate” approach to tackling monkeypox is needed, and that Imvanex is now available for vaccination. France has issued a decree authorizing the use of Imvanex and the importation of its US equivalent, Jynneos, and Germany has ordered thousands of doses of the vaccine. SIGA’s antiviral tecovirimat can also be used for monkeypox in the EU.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Moment Of Truth For Seven EU Filings; Cytokinetics To Make Its Case For Heart Failure Drug
The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.