CBER Director Peter Marks says the center implemented a lot in a short amount of time for the RMAT pathway.
After a number of flavorless news years within the US FDA's Center for Biologics Evaluation and Research (CBER), 2017 took a 180 degree turn with several transformative developments for the center, highlighted the introduction of the Regenerative Medicines Advanced Therapies (RMAT) pathway and by the approval of the first US gene therapies.
Then President Obama signed the 21st Century Cures Act into law on Dec. 13, 2016, and the center immediately began...
<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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