Novartis and German insurers have agreed a payment by outcomes deal for its CAR-T therapy Kymriah.
Novartis and GWQ, a group of German health insurers, are piloting an agreement that will see the Swiss pharma firm repay some of the cost of its CAR-T cell therapy Kymriah (tisagenlecleucel) if survival outcomes are not met. It is the first outcomes-based deal for an anticancer gene therapy and CAR-T therapy in Germany, say Novartis and GWQ.
With the aim of securing faster access for patients, the agreement will run until
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
