A parallel assessment mechanism that will allow new medicines in any therapeutic area to be considered for funding sooner is being introduced in New Zealand, where the new coalition government is working to repeal last year’s landmark Therapeutic Products Act.
Streamlined assessments that New Zealand’s regulator and health technology assessment (HTA) body offer for cancer drugs are being expanded to cover medicines in all therapeutic areas, says the new coalition government, which plans to repeal the landmark Therapeutic Products Act (TPA) that was passed last year.
HTA body Pharmac is to assess funding applications for all new medicines that are still being evaluated for marketing authorization...
<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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