The R&D-based pharma industry has welcomed the “more careful and considered approach” taken by EU ministers to the European Commission’s proposed compulsory licensing system, but says there is room for further improvement.
The Council of the EU has adopted its negotiating position on the draft Regulation on EU-level compulsory licensing, saying it wants to strengthen the rights of intellectual property holders and stressing the “last-resort” nature of compulsory licensing.
The council’s “negotiating mandate,” which will form the basis of talks with the European Parliament on the draft regulation, also...
<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.
