New opioids will need to provide a “significant advantage” over approved products under new requirements that treat opioids “differently” from other drug classes, outgoing Commissioner Gottlieb says.
Throughout his two-year tenure at the US FDA, outgoing Commissioner Scott Gottlieb has been known for a deliberate, incremental approach to regulatory policy, ensuring both a consistent drumbeat of news while exhibiting constant (albeit often small) signs of progress.
That communications strategy was on full display at Gottlieb’s penultimate congressional appearance: a Senate Appropriations Subcommittee hearing on 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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