The EMA says that in light of the disappointing results of the ANNOUNCE trial, no new treatments should be initiated with Lilly’s Lartruvo in patients with soft tissue sarcoma. This is the first time the agency has taken action such as this on a product that has received a conditional marketing authorization.
The European Medicines Agency says that no new patients should be started on Lilly Research Laboratories’s Lartruvo for soft tissue cancer after the product failed to meet the primary endpoint of overall survival in the Phase III ANNOUNCE trial.
Lartruvo has a conditional marketing authorization (CMA) in Europe and was awaiting confirmatory efficacy data. The EMA told the Pink...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
