Novartis, having now submitted its CAR-T therapy CTL019 to the European Medicines Agency for approval, should learn shortly whether the product will be assessed under the agency’s accelerated procedure.
Novartis has applied for approval to market its CAR-T cell therapy CTL019 (tisagenlecleucel) in the EU, and should soon find out whether the European Medicines Agency will agree to fast track its assessment.
The company, which made history in August when CTL019 became the first CAR-T therapy to be approved in the US,...
<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.
