EU sponsors of two investigational drugs – one to treat the rare genetic Pompe disease and the other for patients with severe inherited form of high cholesterol – have requested a speedy review of their respective marketing applications.
The European Medicines Agency will decide this week whether to fast-track Sanofi’s and Regeneron Pharmaceuticals’ planned EU marketing applications for avalglucosidase alfa (to treat Pompe disease) and evinacumab (for hypercholesterolemia), respectively.
The accelerated assessment requests by Sanofi and Regeneron in relation to their respective investigational drugs are listed on the
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
