EU reviewers have recommended marketing approval for two new medicines, but have turned down another product.
The European Medicines Agency has recommended pan-EU marketing authorization for Nexviadyme (avalglucosidase alfa), Sanofi Genzyme’s enzyme replacement therapy for the rare, degenerative muscle disorder, Pompe disease. Nexviadyme is under priority review in the US for the same indication.
On the other hand, the agency has recommended against approving Nouryant (istradefylline), Kyowa Kirin’s add-on drug for treating “off”...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
