Eight new marketing applications including ones from BMS/Acceleron Pharma and Pfizer are up for an opinion at the April meeting of the European Medicines Agency’s drug evaluation committee, the CHMP.
The European Medicines Agency is this week deciding whether to recommend pan-EU marketing approval for eight new drugs including luspatercept, Bristol-Myers Squibb Co. and Acceleron Pharma’s treatment for myelodysplastic syndromes (MSD) and beta-thalassemia that this month secured a second key approval in the US.
Luspatercept last November became the first US Food and Drug Administration-approved treatment for anemia in beta thalassemia (US brand name...
<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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