The European Medicines Agency has recommended the conditional approval of Mirati’s lung cancer drug Krazati following a re-examination of its initial negative opinion.
Patients with KRASG12C-mutated advanced non-small cell lung cancer (NSCLC) could soon have another treatment option after the European Medicines Agency’s human medicines advisory committee, the CHMP, backed Mirati Therapeutics, Inc.’ Krazati (adagrasib) for conditional approval in the EU.
The good news for Mirati has come four months after an initial disappointing CHMP decision on its conditional marketing authorization...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
