Variant vaccine approvals can be based on manufacturing/quality and non-clinical data as long as data on earlier vaccines support the predictability of clinical immunogenicity and reactogenicity.
The European Medicines Agency has recommended that COVID-19 vaccines for the 2024-25 vaccination campaign should be updated to target the new JN.1 variant of the SARS-CoV-2 virus, which it says “globally overtook the previously circulating XBB family of variants between December 2023 and January 2024.”
JN.1 belongs to the BA.2.86 family of Omicron subvariants, which is antigenically distant from the XBB family and from previously...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
