Even at the final step, FDA’s review of Sarepta's Duchenne muscular dystrophy drug remained collaborative and contentious, as Commissioner Califf's view that accelerated approval would not set a new precedent drew pushback from ODE I Director Unger, while Acting Chief Scientist Borio said the draft decision downplayed the 'miniscule' amount of dystrophin with eteplirsen.
FDA officials involved in the dispute over whether to approve Sarepta Therapeutics Inc.'s Exondys 51 (eteplirsen) did not hold back their criticisms when FDA Commissioner Robert Califf circulated his draft decision supporting accelerated approval for the Duchenne muscular dystrophy drug.
Office of Drug Evaluation I Director Ellis Unger questioned Califf's conclusion that Center for Drug Evaluation and Research Director Janet...
<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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