Takeda could soon learn whether the European Medicines Agency will recommend in favor of approving its dengue vaccine, which was reviewed under a new evaluation route that simultaneously targets EU and non-EU countries.
Qdenga, the dengue vaccine from Takeda Pharmaceutical, which was the first product to test drive the European Medicines Agency’s parallel review route for EU and non-EU markets, is up for opinion by the agency on whether it should be approved.
The EMA is due to adopt a decision on the vaccine this week, around two and a half years after...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
