The first pilot for the Benelux joint pricing and reimbursement process has failed. Negotiations between Vertex and the ministries of health in Belgium and the Netherlands have ended with no agreement on price for cystic fibrosis drug Orkambi.
The first pilot in the initiative to develop a joint reimbursement process between smaller EU countries has been brought to an end because there was “no prospect of an acceptable price,” according to the Dutch heath ministry. Authorities in Belgium and the Netherlands had been in talks over Vertex’ cystic fibrosis drug Orkambi (lumacaftor/ivacaftor).
Dutch and Belgian authorities terminated talks with Vertex, saying that the drug was not cost effective and that it therefore...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
