The EMA offers more flexibility than the US FDA when it comes to missed primary endpoints in certain circumstances, meaning a potentially quicker route to authorization in the EU.
Spanish biotech firm Minoryx Therapeutics hopes a newly approved Phase III trial will lead to the US approval of its orphan drug leriglitazone for X-linked adrenoleukodystrophy (X-ALD) in 2026 at the earliest.
Meanwhile, the European Medicine Agency’s review of the drug is well under way, with a decision on marketing authorization expected...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
