Having completed a rolling review, the vaccine is now being evaluated by the European Medicines Agency for conditional marketing authorization under an accelerated timeline.
The EU could see its fifth COVID-19 vaccine approved in a matter of weeks after the European Medicines Agency said it had begun reviewing Novavax, Inc.’s application for a conditional marketing authorization (CMA) for Nuvaxovid (also known as NVX-CoV2373).
The EMA said the evaluation would be carried out under an accelerated timeline because it had already assessed a substantial...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
