Developers of three new drugs, including two orphan medicines, that are nearing the final stages of their EU regulatory review cycle could be asked to explain why the European Medicines Agency should recommend approval of their products.
Sponsors of sparsentan, leriglitazone and pegcetacoplan were this week due or possibly due to appear before the European Medicines Agency to explain why their respective drugs, which are in the late stages of the regulatory review cycle, merit pan-EU approval.
Sparsentan is Travere Therapeutics/CSL Vifor’s non-immunosuppressive therapy for treating primary immunoglobulin A nephropathy (IgAN), and leriglitazone is
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
