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.
With UK cases of monkeypox now having soared to 190, the country’s four public health agencies have issued a joint statement outlining a set of proposals for suppressing transmission of the disease in the community, including the use of Bavarian Nordic’s smallpox vaccine, Imvanex.
“Pre- and-post exposure prophylaxis using Imvanex is available for deployment,” according to the statement, which was agreed by the UK...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
