Fennec Pharmaceuticals says that its new formulation of sodium thiosulfate for preventing cisplatin-induced hearing loss in children targets a critical unmet medical need.
Fennec Pharmaceuticals is counting on the European Medicines Agency’s rarely used pediatric use marketing authorization (PUMA) pathway to pave its way to winning pan-EU approval for the unique formulation of sodium thiosulfate it is developing to prevent cisplatin-induced hearing loss in children.
The marketing application for the product was recently validated by the EMA, which this month added the drug to its...
<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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