Japanese company Daiichi Sankyo has its eye on first-line FLT3-ITD AML indication after rejection of relapsed/refractory plans in EU and US.
Daiichi Sankyo is not seeking to persuade the European Medicines Agency to change its mind on its refusal to recommend quizartinib for approval across the EU as treatment for relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).
It seems the Japanese company is planning instead at a future date to file for approval of quizartinib in first-line...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
