Will regulators in the EU follow their US counterparts in requiring more efficacy data for Daiichi Sankyo’s acute myeloid leukemia drug quizartinib, which is already approved in Japan?
Sponsors of nine new drugs, including Daiichi Sankyo for its anticancer medicine, quizartinib, Janssen for its anti-depressant, esketamine, and AbbVie for its rheumatoid arthritis treatment, upadacitinib, are set to learn whether their products are on track to secure a pan-EU approval.
Marketing authorization applications (MAAs) for the products are up for an opinion this week by the European Medicines Agency’s drug...
<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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