Sanofi says it will engage further with NICE after the health technology assessment body rejected Sarclisa for previously-treated multiple myeloma, and that it is “hopeful a way forward can be found.”
Sanofi has hit another bump in the road to reimbursement for its multiple myeloma therapy Sarclisa (isatuximab) after NICE, the health technology assessment (HTA) body for England and Wales, said the drug was not cost effective when used in combination with pomalidomide and dexamethasone (pom-dex) for relapsed and refractory multiple myeloma (RRMM).
It has been almost four years since the monoclonal antibody was granted an EU marketing authorization, which was also valid...
<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.
