Shire and Regeneron/Sanofi are among the companies that have recently submitted investigational new treatments for approval across the EU.
Shire Pharmaceuticals’ investigational drug lanadelumab, for the treatment of hereditary angioedema (HAE), has joined the select group of products that are being reviewed under the European Medicines Agency’s accelerated assessment pathway.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted Shire’s accelerated assessment request for lanadelumab at its February...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
