Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for pan-EU approval.
Astellas Pharma’s Vyloy (zolbetuximab) is on track to secure EU-wide approval for treating gastric or gastro-esophageal junction adenocarcinoma, while Ipsen’s Iqirvo (elafibranor) is poised to receive conditional EU marketing approval for treating the rare liver disease, primary biliary cholangitis.
Both drugs, which have orphan status in the EU, are among 14 products that the European Medicines Agency’s human medicines...
<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.
