The EU marketing application for the HER2-targeted antibody drug conjugate has been fast-tracked and is now up for an opinion from the European Medicines Agency.
Daiichi Sankyo and AstraZeneca could find out this week whether the European Medicines Agency will recommend that their drug, trastuzumab deruxtecan, should be granted pan-EU marketing approval for treating unresectable or metastatic HER2-positive breast cancer.
The HER2-targeted antibody drug conjugate (ADC) is already approved as Enhertu for the same indication in the US and Japan,...
<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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