The European Medicines Agency has agreed to fast track the review of four marketing applications in recent months.The products include AstraZeneca's advanced breast cancer treatment, Enhertu, two investigational CAR-T therapies, and a potential treatment for rare genetic disorders of obesity.
The European Medicines Agency will fast-track its review of the planned EU marketing authorization application (MAA) for Enhertu (trastuzumab deruxtecan), AstraZeneca and Daiichi Sankyo’s advanced HER2-positive breast cancer treatment.
The MAA for the potential blockbuster is likely to be submitted soon – if indeed it hasn’t been already –...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
