Vertex has managed to secure a deal to provide Scottish cystic fibrosis patients with access to Orkambi and Symkevi. The promise of real world data and a price discount has convinced the Scottish government to say yes to the treatments, which had earlier been rejected by the Scottish Medicines Consortium.
In a UK first, the Scottish authorities have changed their mind and agreed to fund Vertex’s cystic fibrosis drugs, Orkambi (lumacaftor/ivacaftor) and Symkevi (tezacaftor/ivacaftor). The company and the government have struck an agreement under which Vertex will offer a confidential discount and a commitment to gather real world data on use of the products.
Only last month, the health technology appraisal body, the Scottish Medicines Consortium, said Vertex had failed to justify the cost...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
