Akcea Waylivra's Surrogate Endpoint Gains Support At US FDA Advisory Committee
Executive Summary
In wide-ranging meeting, majority of panelists believe volanesorsen's surrogate marker will correlate to clinical outcomes such as reduced pancreatitis.
You may also be interested in...
Akcea C-Suite Upheaval’s Reasons Unclear, Firm Set To Take In More Ionis Programs
Akcea terminates top three execs while praising their accomplishments in building up the Ionis spinout. Stock finished the trading day down nearly 20%.
2018 Complete Response Letters: Efficacy Issues Drove Most Product Rejections
US FDA issued at least seven rejections to novel products; opioid analgesic sponsors had very little success, while biosimilar developers had a so-so year.
Complete Response Letters See Uptick With US FDA's Thumbs Down For Waylivra
In first half of 2018, CRLs were rarely issued for CDER-regulated novel agents, but FDA's rejection of Waylivra marks second in two weeks.