The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.
The European Medicines Agency is this week deciding whether to recommend pan-EU marketing approval for seven new products, including Idorsia’s aprocitentan, which last month became the first oral anti-hypertensive therapy that works via a new therapeutic pathway to be approved in the US in almost 40 years.
In addition, the EMA is expected to hold an oral explanation meeting at which Cytokinetics will be able to...
<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.
