EU member state authorities have been told they can use Jynneos, the US version of Bavarian Nordic’s smallpox vaccine, for the prevention of monkeypox. The bloc is also buying some 110,000 doses of the vaccine, with deliveries expected to begin shortly.
The European Medicines Agency has begun assessing data on the use of Bavarian Nordic’s smallpox vaccine, Imvanex, against monkeypox as it awaits a formal marketing application from the company for the vaccine’s use in this indication in the EU.
In the meantime, the EMA’s Emergency Task Force (ETF) has recommended that in view of the limited supplies of Imvanex in Europe, the US-approved version of the vaccine, Jynneos, can
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.
European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.
