The European Medicines Agency is looking at how it can generate real-world evidence on multiple myeloma and non-small cell lung cancer using its new DARWIN EU platform so that the outcomes can also be of use for health technology assessment bodies and payers.
The European Medicines Agency is exploring the feasibility of running two real-world evidence studies that could be of use to health technology assessment (HTA) bodies and payers as well as the agency in their respective areas of decision-making.
The first study will look at the natural history of multiple myeloma, while the second will focus on non-small cell...
<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>
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.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
