The SMC, the Scottish health technology assessment body, has approved reimbursement for the first drug to win an innovation passport from the UK regulator.
MSD has welcomed the first European pricing and reimbursement recommendation for its rare disease drug Welireg (belzutifan) in Scotland, but is clearly disappointed that the product will not be appraised under NICE’s highly specialized technologies process in England.
Soctland’s health technology appraisal body, the SMC, has okayed Welireg for use on the National Health Service for adult patients...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
