Outcomes measures in the neurodegenerative disease space are not yet well understood by regulators, according to Amylyx, which recently received a negative opinion from the EMA for its amyotrophic lateral sclerosis drug, Albrioza.
Following a negative opinion from the EMA’s human medicines committee, the CHMP, for its orphan drug Albrioza (sodium phenylbutyrate/ursodoxicoltaurine) for amyotrophic lateral sclerosis (ALS), Amylyx Pharmaceuticals, Inc. told the Pink Sheet that regulators do not yet fully understand the best outcomes measures for neurodegenerative diseases.
Justin Klee and Joshua Cohen, co-CEOs of Amylyx, said that while experts were aligned on the best way to measure...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
