The European Commission’s latest consultation on overhauling the EU legislation on medicines for children and for rare diseases has drawn some sharp responses from stakeholders.
The R&D-based European pharmaceutical industry has again rejected proposals to reduce the incentives for orphan and pediatric drug development, promote faster generic and biosimilar competition, and introduce a legal definition of “unmet needs.”
According to the European Commission, while the EU orphan and pediatric drug regulations were designed to improve treatment options, they...
<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.
