After an initial funding rejection last year, CSL Behring’s gene therapy for hemophilia B is to be made available to English patients under the Innovative Medicines Fund via a “first-of-its-kind” agreement. Hemgenix is also the subject of a funding deal in Denmark.
CSL Behring says its gene therapy for hemophilia B, Hemgenix (etranacogene dezaparvovec), will be made available in England immediately and hopes the first patient will be treated by the autumn, after the health technology assessment body NICE said the therapy should be reimbursed through a managed access scheme under the Innovative Medicines Fund.
“The first-of-its kind agreement will enable eligible patients to access the first and currently only gene therapy approved for hemophilia...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
