The European Medicines Agency’s drug evaluation committee, the CHMP, is this week considering products from Alexion Pharmaceuticals and Roche/Chugai Pharmaceutical who are both vying for a share of the as yet untapped EU market for neuromyelitis optica spectrum disorder.
The European Medicines Agency is set to decide this week whether to recommend for approval what could become Europe’s first treatment for neuromyelitis optica spectrum disorder (NMOSD) –Alexion Pharmaceuticals’ monoclonal antibody Soliris (eculizumab).
In addition, the EMA is expected to decide whether to fast track the planned marketing authorization application (MAA) for another...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
