This week has seen two key decisions by the European Medicines Agency designed to speed up the availability of COVID-19 vaccines in the EU.
The European Medicines Agency has brought forward by six days the date of the meeting at which its drug evaluation committee, the CHMP, is expected to make a recommendation on the approval of Moderna, Inc.’s COVID-19 vaccine, mRNA-1273. This is the second of two such decisions taken by the agency this week.
A meeting on the Moderna vaccine had originally been scheduled for 12 January, but the EMA said that in view...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
