Aurinia Has FDA OK For Phase III Voclosporin Trialing In Lupus Nephritis
Following consultations with the FDA, Canada's Aurinia Pharmaceuticals plans to run a single Phase III trial for voclosporin in lupus nephritis and then proceed to filing an NDA.
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Long-term data from the AURA-LV study in lupus nephritis show voclosporin is superior to standard of care, raising expectations for future Phase III success.
Aurinia Pharmaceuticals Inc. has appointed Charles Rowland CEO, replacing Stephen Zaruby who will be resigning as the company's CEO and from its board of directors. Rowland was vice president and chief financial officer (CFO) of ViroPharma Inc. until it was acquired by Shire PLC. in 2014. Prior to this, he held various leadership positions at biotech and pharma companies and most recently was interim co-CEO, executive vice president, CFO for Endo Pharmaceuticals Inc. Previously Rowland held positions at Biovail Corp., Breakaway Technologies Inc., Pharmacia Corp., Novartis AG and Bristol-Myers Squibb.
EXACT-Tx will use funds from a NOK155m private placing to harness ultrasound in precision therapeutic targeting across a variety of indications and product classes.