The sponsors of five EU-approved Janus kinase inhibitors for inflammatory conditions will have to update their product information to reflect new measures and warnings from the European Medicines Agency.
The European Medicines Agency has recommended measures to minimize the risk of cardiovascular problems, cancer and other serious side effects associated with five Janus kinase (JAK) inhibitors that are approved in the EU for chronic inflammatory disorders.
The risk minimization measures apply to Xeljanz (tofacitinib) and Cibinqo (abrocitinib), both from Pfizer, and Jyseleca (filgotinib), Olumiant (baricitinib)...
<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.
