Three companies are set to learn this week whether the European Medicines Agency will fast track its review of their soon-to-be-filed EU marketing applications.
The European Medicines Agency is this week considering requests to fast-track its review of planned EU marketing applications for three investigational products including lumasiran, the RNAi therapeutic Alnylam Pharmaceuticals is developing to treat primary hyperoxaluria type 1 (PH1).
The other products for which accelerated assessments are being sought are Eiger BioPharmaceuticals’ lonafarnib, for treating the ultra-rare conditions...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
