Belgium, the Netherlands, Luxemburg and Austria are continuing their collaboration on improving access to medicines and are finalizing a proposal on a joint horizon scanning initiative.
The BeNeLuxA initiative, made up of Belgium, the Netherlands, Luxembourg and Austria, is continuing collaboration on improving access to costly, high-impact medicines and is now finalizing a proposal on how the four countries, and potentially others, could work together on horizon scanning.
The so-called BeNeLuxA Collaboration Initiative focuses on drugs with costs that “are expected to be disproportionately high per year or...
<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>
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
<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>
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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