Within one year of its establishment, DARWIN EU has started reaping benefits for EU drug regulators commissioning studies using real-world data to better understand diseases, populations and the uses and effects of medicines. The studies can be performed faster, cheaper and at increased capacity.
The European Medicines Agency says efforts are afoot to further strengthen the new EU-wide platform for generating real-world evidence (RWE) – the Data Analysis and Real World Interrogation Network (DARWIN EU), which has already completed its first set of studies commissioned by the agency.
“DARWIN EU has ambitious plans for 2023” during which it will “onboard ten additional data partners and initiate around 16...
<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.
