The MHRA says that having a complete picture of all upcoming filings will allow it to ensure “consistent and predictable” timelines for assessments and identify “potentially transformative technologies” at an early stage.
The UK medicines regulator, the MHRA, in planning to take a more formal approach to gathering data on products coming through companies’ pipelines so as to have a better idea of the number and type of drug applications it can be expected to deal with over the coming years.
It has asked marketing authorization holders (MAHs) to provide it with information on their planned or potential approval submissions, saying...
<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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