The European Medicines Agency produces a monthly list of the marketing authorizations that are under review at the agency. The latest list contains just two new entries.
There are just two additions to the latest list of products under review at the European Medicines Agency – lumasiran, the RNAi therapeutic Alnylam Pharmaceuticals is developing for the treatment of primary hyperoxaluria type 1 (PH1), and Eiger BioPharmaceuticals’ lonafarnib, a potential new treatment for progeria and progeroid laminopathies.
Both products have orphan status and are being reviewed under the EMA’s accelerated assessment mechanism.
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
