The UK Health Security Agency says it took a number of factors into account when deciding to use Bavarian Nordic’s smallpox vaccine Imvanex, including high European manufacturing standards, the US approval for monkeypox, and the lack of an alternative UK-licensed vaccine.
As cases of monkeypox continue to rise, the UK Health Security Agency (UKHSA) has announced that it has purchased supplies of Bavarian Nordic’s smallpox vaccine, Imvanex, which is now being offered to close contacts of those diagnosed with monkeypox to reduce the risk of symptomatic infection and severe illness.
On 26 May, the UKHSA said the number of confirmed cases in the UK had risen to 90 in total:...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
