After Pfizer saw increased risks in a surveillance study of Xeljanz, three other products have also seen their user fee dates pushed back; if FDA were to convene an expert panel, it could lead to more consistent labeling across the class, as requested in a recent citizen petition.
A slew of recent user fee date extensions for oral JAK1-inhibitors has prompted speculation that the US Food and Drug Administration might convene an advisory committee to vet safety concerns with the class.
Although product sponsors are not providing much in the way of details, the recent goal date extensions come in the...
<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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