The company says it expects a “positive decision” on the first approval application for a protein-based coronavirus vaccine in the UK. If approved, NVX-CoV2373 would become the fifth COVID-19 jab to reach the market there.
Novavax, Inc. has completed its rolling regulatory submission to the UK regulator, the MHRA, for the approval of its COVID-19 vaccine NVX-CoV2373. If approved, it will join the four other coronavirus vaccines already on the market.
The filing is noteworthy for two reasons, one being that it is the first for a protein-based coronavirus vaccine in...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
