Realignment played key role in keeping assessments on track as COVID-19 buckled pharmaceutical supply and distribution chains and prevented inspections.
A fortuitous enhancement of its approach to quality assessments launched by the US Food and Drug Administration’s Office of Pharmaceutical Quality over the holidays in December 2019 played a key role in enabling the office to keep up with the whirlwind of activity brought on by the coronavirus pandemic, OPQ director Michael Kopcha told the Pink Sheet.
Another key factor: people put in a lot of extra hours.
<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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