The EU is set to be the first market to approve bluebird bio’s one-time gene therapy for cerebral adrenoleukodystrophy.
Skysona (elivaldogene autotemcel), bluebird bio’s gene therapy for cerebral adrenoleukodystrophy (CALD), is set to win its first ever marketing authorization now that the European Medicines Agency has recommended that the one-time treatment for the potentially fatal neurodegenerative disease be approved throughout the EU.
Skysona will be the first one-time gene therapy approved to treat CALD, a rare disease that occurs almost exclusively in...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
