Serenity's Noctiva and Ferring's Nocdurna both use desmopressin to treat nocturia, but Nocdurna has racked up three complete response letters while Noctiva was approved on the first try. US FDA explains how trial design and secondary endpoints influenced its decision in its denial of a Ferring citizen petition.
Secondary endpoints in Serenity Pharmaceuticals LLC's pivotal trials of Noctiva helped to demonstrate the clinical meaningfulness of the desmopressin nasal spray for nocturia, FDA said in its denial of a potential Noctiva competitor's citizen petition.
FDA approved Noctiva, a nasal spray formulation of the vasopressin analog desmopressin, on March 3 for treatment of nocturia due...
<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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