Approval applications for nine products received a positive opinion this week from the European Medicines Agency’s drug evaluation committee, the CHMP, and one product was turned down.
Novartis and Amgen’s first-of-its-kind migraine drug, Aimovig (erenumab), and Akcea Therapeutics’ new treatment for patients with hereditary transthyretin amyloidosis, Tegsedi (inotersen), are among nine products that the European Medicines Agency this week recommended for approval across the EU.
The other drugs that received a positive opinion from the agency’s Committee for Medicinal Products for Human Use (CHMP) during...
<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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