Compassionate Use Programs In APAC: China Breaks The Ice
Compassionate use programs (CUP) are a developing field in Asian countries. In the majority of Asian states, the CU applies to Named-Patients Program (NPP). In the most countries, understanding of CUP for unapproved drugs is poor among the public, and even for professional communities.
You may also be interested in...
The first-in-class candidate met two primary endpoints in a Phase II trial for C3 glomerulopathy, suggesting potential edge over ChemoCentryx and Vifor’s competitor avacopan.
The new ALS product is a fixed-dose combo of two ingredients – sodium phenylbutyrate and taurursodiol – that some patients currently are compounding. Amylyx says it will explore ‘all options’ in addressing that, noting its strong IP for Relyvrio, but also committing to access.
Keeping Track: US FDA Clears Santen’s Omlonti, Fennec’s Pedmark; Lilly’s Retevmo Adds Tumor-Agnostic Claim
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker