A number of new products have been submitted for review at the European Medicines Agency. While marketing authorization applications from ViiV Healthcare and BioMarin Pharmaceutical are being fast-tracked, a submission from Incyte is not.
ViiV Healthcare’s HIV drug, fostemsavir, and PTC Therapeutics’ gene therapy for the central nervous system disorder, AADC deficiency, are among 11 new products for which marketing authorization applications (MAAs) have been submitted to the European Medicines Agency for review.
The other newly filed MAAs for potential approval throughout the EU include BioMarin Pharmaceutical’s gene therapy, valoctocogene roxaparvovec, for...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
