Amylyx is standing by the clinical trial data it used to support its EU marketing application for its amyotrophic lateral sclerosis treatment, saying that the same data formed the basis of approvals for Albrioza in the US and Canada.
Amylyx Pharmaceuticals will be asking the European Medicines Agency to re-examine its decision to recommend against pan-EU marketing approval for Albrioza (sodium phenylbutyrate/ursodoxicoltaurine), the company’s treatment for amyotrophic lateral sclerosis (ALS) that is approved in the US and Canada.
“We are confident in the strength of our CENTAUR trial data, which we believe meets the criteria for conditional approval,”...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
