Pfizer’s Talzenna is not cost effective enough to be used on the National Health Service for patients with HER2-negative advanced breast cancer with inherited BRCA mutations, according to draft guidance from England’s health technology assessment body NICE.
NICE, the body that makes reimbursement recommendations for England’s National Health Service, has given the thumbs down to Pfizer Inc.’s PARP inhibitor Talzenna (talazoparib) for the treatment of certain types of advanced breast cancer in preliminary guidance on 28 July, saying the drug is not a cost-effective use of NHS resources.
In it draft guidance, NICE cited Talzenna’s lack of overall survival benefit compared with chemotherapy as a main reason...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
