An unusual managed access program for Zolgensma designed by Novartis and AveXis has been attacked on ethical grounds, with critics claiming it does not properly allot the gene therapy to patients most in need. The companies have rejected the criticism, saying the program is fair and equitable.
Novartis/Avexis have come under fire from EU member states, patients and legal experts for their “lottery-style” managed access program (MAP) for the gene therapy for spinal muscular atrophy, Zolgensma. Critics have cited ethical concerns and claim the program is a reputational risk for the companies and the wider pharmaceutical industry.
But Nils Hoppe from the law firm Hill Dickinson LLP says the controversy surrounding the program could generate dialogue about...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
