US FDA lauds collaborative development of surrogate endpoint that allowed for accelerated approval of the first two drugs for the rare kidney disease. The program was presented as an example of novel endpoints for rare diseases at a Duke/FDA workshop.
The surrogate endpoint that propelled the first two therapies for the rare kidney disease IgA nephropathy will now be stress-tested in the US FDA’s review of Calliditas Therapeutics AB’s recently submitted application to convert the accelerated approval of Tarpeyo to full approval.
Calliditas announced the sNDA submission on 21 June 2023, about two weeks after the development of reduction in proteinuria as...
<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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