A steering group set up by the EU regulator has produced a list of five vaccines and nine therapeutics that it deems essential for use in preventing and treating COVID-19. It will also draw up a list of critical medicines for use in emergency and intensive care during health crises.
The European Medicines Agency has published a list of “critical” vaccines and medicines for use against COVID-19, as part of its expanded remit in managing actual or potential shortages of medicinal products during the pandemic.
The list comprises five vaccines and nine therapeutics whose supply and demand will be closely monitored in EU/European Economic Area...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
