Genentech Lucentis priority review
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Genentech's BLA for its wet age-related macular degeneration treatment Lucentis (ranibizumab) is granted a priority review at FDA, giving the VEGF antibody a June 29 user fee goal date. Genentech's submission includes a head-to-head trial with Novartis/QLT's photodynamic therapy Visudyne (verteporfin). Genentech has referred to Lucentis as the first wet AMD treatment to show a clinical benefit over PDT in a head-to-head study setting (1Pharmaceutical Approvals Monthly June 2005, p. 12). In conjunction with the priority review designation, Genentech announced preliminary, two-year data from its Phase III MARINA study showing improvement at two years...
You may also be interested in...
Retaane “Approvable” For Macular Degeneration; Alcon Plans July Meeting With FDA
Alcon expects to meet with FDA in July to discuss a May 23 "approvable" letter for its wet age-related macular degeneration agent Retaane (anecortave acetate suspension)
News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.
Finance Watch: Canaan, Regeneron Reveal New Funds For Start-Ups
Private Company Edition: Regeneron launched a $500m venture fund and Canaan added $100m, bringing the venture firm’s recent total to $1bn-plus. Also, incubators plan to grow over the next decade and in recent financings Avenzo raised $150m and Nvelop launched with $100m.