FDA notified the company the US review goal date for the psoriasis pill has been extended three months from Nov. 16 to Feb. 16.
Valeant Pharmaceuticals International Inc. revealed during its third quarter sales and earnings call Nov. 8 that a key pipeline product, the IL-17 blocker Siliq (brodalumab) for plaque psoriasis, has been delayed by FDA.
CEO Joseph Papa said the user fee date for the biologics license application (BLA), pending at FDA, has been pushed...
<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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