A direct marketing authorization application to the UK medicines regulator offered a quicker route to approval for Novartis’ prostate cancer treatment Pluvicto than following the international Access Consortium process, because of the novel nature of the therapy, according to the company.
Novartis AG decided against using the international Access Consortium work-sharing procedure to obtain a marketing authorization for its radioligand therapy Pluvicto in Great Britain because it felt that a direct application to the UK regulator, the MHRA, would be faster.
The Access Consortium had not yet assessed a radioligand therapy (RLT), which is an emerging treatment approach, so it was...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
