Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.
BioMarin Pharmaceutical’s Roctavian (valoctocogene roxaparvovec) is on track to be approved as the first gene therapy in the EU for hemophilia A, after the European Medicines Agency recommended that it be granted a conditional marketing authorization.
Roctavian is intended as a one-time infusion for treating severe hemophilia A in adult patients who do not have factor...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
