Pfizer’s Talzenna is soon to be made available to National Health Service patients in England and Wales with HER2-negative advanced breast cancer with inherited BRCA mutations, after the company agreed to provide the PARP inhibitor at a larger discount than it originally offered.
NICE, the health technology assessment (HTA) body for England, has recommended Pfizer’s Talzenna (talazoparib) for reimbursement, after initially turning the drug down due to its cost last July.
The positive funding decision is aligned with similar market access agreements made in other European countries, but it has come...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
