The European Medicines Agency said it was possible to use immunobridging studies to authorize COVID-19 vaccines now that a number of COVID-19 vaccines authorized in the EU are proven to be safe and effective and can be used as comparators in trials.
VidPrevtyn Beta, from Sanofi and GSK, has become the first COVID-19 vaccine to win EU marketing approval based on immunobridging trials.
Well-justified and appropriately designed immunobridging studies that compare an investigational vaccine with an approved one “are adequate for authorizing future...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
