The withdrawal of Merck’s Keytruda NSCLC application in Europe suggests the firm filed too early, and it will now need to wait for the results of the Phase III KEYNOTE-189 study before submitting the drug again to the EMA.
Merck & Co. Inc.’s decision to pull its PD-1 inhibitor Keytruda (pembrolizumab) from the EU approval process for lung cancer has raised a few eyebrows, with some analysts saying the company was jumping the gun in seeking marketing authorization on the back of Phase II trial data. It will now have to wait until Phase III results are ready before filing again.
At least one analyst says he may have to revise his forecast for Keytruda sales growth, which was based partly...
<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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