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...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
