New EU Approvals
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.
EMA Report Highlights Parallel Regulatory/HTA Consultations Among Achievements
A report from the EMA summarizing the mid-term achievements of its Regulatory Science Strategy to 2025 covers health technology assessments and a range of other topics.
Upstaza: First Gene Therapy For Ultra-Rare Disorder AADC Deficiency Receives English Funding
The single-dose gene therapy for aromatic L-amino acid decarboxylase in children is to be made available on the National Health Service following a confidential commercial deal between NHS England and PTC Therapeutics.