The proposed European Health Data Space is expected to boost innovation in preventing, diagnosing and treating disease and to support the long-term competitiveness of the EU’s medical sector. The pharmaceutical industry has broadly welcomed the move but wants to see certain safeguards and guarantees put in place.
EU proposals to greatly increase access to health data and the use of real-world evidence in EU policy making could allow the prices of drugs for cancer, diabetes and other diseases to be renegotiated “based on the observed real-world effects,” according to the European Commission.
“According to experts consulted, in a medium-sized EU country, a 5% saving from re-negotiating the prices in drug cost in...
<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.
