Payment for outcomes has played an important role in enabling Gilead to secure reimbursement for Yescarta in some EU markets. It is likely to be the key focus for the company as it works to expand patient access to the potentially transformative CAR-T therapy across Europe.
Gilead Sciences has secured temporary reimbursement in France and Germany and in parts of the UK for its potentially transformative and high-cost CAR-T therapy Yescarta but has yet to secure reimbursement in other larger EU markets such as Italy.
Linking outcomes to payment has played a substantial role in reimbursement decisions concerning the big-ticket therapy to date and Gilead...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
