The European Medicines Agency’s pharmacovigilance committee has reviewed the updated advice that EU prescribers will get on enhanced monitoring of spinal muscular atrophy patients treated with Zolgensma following fatal cases of acute liver failure.
Novartis will soon be writing to EU doctors to inform them about two recent fatal cases of acute liver failure in spinal muscular atrophy patients following treatment with Zolgensma (onasemnogene abeparvovec), the company’s one-time gene therapy for children with SMA.
The contents of Novartis’ letter, to be issued as a “direct healthcare professional communication” (DHPC), were reviewed by European...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
