Alnylam has opted to submit its orphan drug Amvuttra for a full benefit assessment in Germany, rather than an abbreviated process that requires no comparative data. In England, the drug was recommended following a pilot for designing a new and faster approach to health technology appraisals.
IQWiG, Germany’s health technology appraisal institute, has welcomed the decision by Alnylam to put its orphan drug Amvuttra (vutrisiran) through a full AMNOG benefit assessment - used to inform pricing - and to forgo an abbreviated option that does not require comparative data.
The institute has again complained that German regulations allow less promising drugs to benefit from “fictitious additional benefit” conferred by...
<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.
