The company says its drug has demonstrated a positive benefit-risk profile in primary HLH in a post-approval real-life setting in the US since Food and Drug Administration approval in 2018.
Swedish Orphan Biovitrum (Sobi) is to appeal against the European Medicines Agency’s decision that its drug Gamifant (emapalumab) should not be approved for use across the EU for the treatment of primary hemophagocytic lymphohistiocytosis (HLH).
Gamifant was one of two drugs that the EMA this week recommended should not be approved. The other is Elzonris...
<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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