It's decision time again at the European Medicines Agency and Roche's Polivy and AstraZeneca's Qternmet are among the products up for an opinion on whether they should be approved in the EU.
Roche/Genentech’s orphan drug for the treatment of mature B cell lymphomas, polatuzumab vedotin (Polivy), is for a second time up before the European Medicines Agency’s key scientific committee for an opinion on whether it should be approved in the EU.
Also up for an opinion is AstraZeneca PLC’s Qternmet XR, a new combination of three established drugs – dapagliflozin,...
<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.
