On November 3, 2016 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that the U.S. Food and Drug Administration (FDA) has accepted Genentech’s Biologics License Application for a subcutaneous formulation of rituximab in multiple blood cancer indications (Press release, Halozyme, NOV 3, 2016, View Source [SID1234516224]). Schedule your 30 min Free 1stOncology Demo! This is a co-formulation with Halozyme’s proprietary recombinant human hyaluronidase enzyme (ENHANZE platform), approved and marketed under the MabThera SC brand in countries outside the U.S. "We are excited to see Genentech and Roche taking steps to bring a subcutaneous formulation of rituximab to patients in the United States," said Dr. Helen Torley, president and chief executive officer. "If approved, this formulation has the potential to reduce administration time for patients and health care practitioners." Including all approved indications, Roche reported total 2015 sales of rituximab in the United States of 3.76 billion CHF.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!