In spite of successfully appealing against previous negative guidance, Pfizer has again failed to secure a positive recommendation from England’s health technology appraisal institute for Oxbryta for hemolytic anemia caused by sickle cell disease, and has been asked to provide more evidence.
NICE, the health technology appraisal (HTA) institute for England and Wales, has again recommended against making Pfizer Inc.’s sickle cell disease (SCD) drug Oxbryta (voxelotor) available via the National Health Service. The institute is asking Pfizer for more data that might help reduce its outstanding uncertainties.
NICE’s decision, published in the form of new draft guidance, follows Pfizer’s successful appeal against previous final draft guidance from...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
