England’s NICE should factor in the impact of patent expiry on future drug prices when analyzing the cost effectiveness of new medicines and should also take account of societal benefits, a group of health economists has said.
NICE, the health technology assessment (HTA) body for England and Wales, sparked controversy late last year after it published provisional draft guidance rejecting Vertex’s Kaftrio (ivacaftor/tezacaftor/elexacaftor), a triple therapy for cystic fibrosis (CF), for use on the National Health Service (NHS).
This decision was changed on 20 June, meaning that the drug, along with two other combination therapies for CF, was...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
