Xofluza is also the first non-cancer drug to be reviewed under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium’s work-sharing initiative.
Roche’s influenza treatment, Xofluza (baloxavir marboxil), has won marketing approval in Australia, Canada and Switzerland after becoming the first drug to be evaluated jointly by three regulatory agencies taking part in an international work-sharing program for new chemical entities (NCEs).
Xofluza is the fourth drug that has been reviewed under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium’s work-sharing program since the initiative was...
<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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