GlaxoSmithKline's potential multiple myeloma treatment is one of several new products that could get an EU marketing thumbs up from the European Medicines Agency this week.
The European Medicines Agency will this week again consider whether to recommend pan-EU marketing approval for belantamab mafodotin, GlaxoSmithKline’s novel multiple myeloma treatment that last week overcame ocular toxicity concerns to score a US Food and Drug Administration panel endorsement.
The antibody-drug conjugate, for relapsed or refractory multiple myeloma, is among a number of new drugs that are up for...
<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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