Mega-merger's top US drug candidates are seeking space in crowded fields. That means they have to get through the FDA fast, and priority review vouchers figure prominently in both improving and lowering the odds.
The proposed merger of AbbVie Inc. and Allergan PLC aims answer AbbVie’s biggest worry: competition for Humira (adalimumab), the world’s top-selling drug with sales of nearly $20bn last year.
Humira biosimilars are expected to launch in the US in 2023. The US Food and Drug Administration has already approved...
<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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