Baxter
This article was originally published in The Gray Sheet
Executive Summary
Firm initiates randomized, 200-patient, multi-center Phase III pivotal study at one site with two sites to follow shortly for the Intercept red blood cell system using Helinx pathogen inactivation technology developed by Cerus. The primary endpoint of the trial will compare Intercept processed red blood cells to red blood cells not prepared with a pathogen inactivation process. A second 50-patient pivotal study to follow "shortly" will compare Intercept cells to control red blood cells in support of patients with chronic anemia due to hereditary disorders such as sickle cell disease...
You may also be interested in...
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.
Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.