An agreement between Vertex and NHS England secures rapid access to Kaftrio, the company’s triple therapy for cystic fibrosis, including for patients with rare mutations not covered by the soon-to-be-granted European marketing authorization. The final price will depend on an assessment by health technology appraisal body NICE.
Vertex Pharmaceuticals and National Health Service England have expanded the portfolio style cystic fibrosis treatment agreement that was struck in October 2019 ending years of acrimony to include the company’s new triple therapy, Kaftrio (ivacaftor/tezacaftor/elexacaftor).
The deal will give patients in England access to Kaftrio as soon as it receives official EU marketing authorization, while...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
