Baxter submits BLA for OBI-1 in acquired hemophilia A, supplemental filing for Rixubis
This article was originally published in Scrip
Executive Summary
Baxter International submitted a biologics license application (BLA) to the US FDA for OBI-1 (recombinant porcine factor VIII) in the treatment of acquired hemophilia A less than a year after the company acquired the product candidate from Inspiration Pharmaceuticals.
You may also be interested in...
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.
Sage’s Dalzanemdor Prospects In Doubt After First Mid-Stage Readout
Dalzanemdor (SAGE-718) showed no difference from placebo in a Phase II Parkinson’s disease study, raising concerns about readouts later this year in Huntington’s and Alzheimer’s diseases.
First Phase III Depression Data For Intra-Cellular’s Caplyta Exceed Expectations
With positive results from the first Phase III trial of lumateperone in major depressive disorder and a second readout expected later this quarter, the company plans a supplemental filing in late 2024.