Zolgensma should receive a conditional approval, says the European Medicines Agency’s drug evaluation committee, the CHMP.
The European Medicines Agency has recommended that eight new medicines be awarded pan-EU marketing authorization, including Zolgensma, AveXis/Novartis’s one-off gene replacement therapy for treating spinal muscular atrophy in babies and young children.
The EMA said that Zolgensma (onasemnogene abeparvovec) should receive a conditional marketing authorization – a regulatory mechanism to facilitate early...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
