Thursday, May 18, 2017 9:03:38 AM
"In January 2007, during her tenure with Shire, Ms. Rockney led the regulatory team and negotiations with FDA for LIALDA™. The FDA approved Shire’s LIALDA™ with MMX® technology, which was the first once-daily oral formulation of mesalamines. Mesalamines are part of the drug class of aminosalicylates, now part of the clinical standard-of-care for treating inflammatory bowel disease. LIALDA™ was found to be effective in Phase 3 trials for inducing remission of active mild-to-moderate ulcerative colitis after eight weeks of treatment. LIALDA™ (also now marketed as Mezavant®) had U.S. sales in 2016 of $714 million, which increased by 16% relative to 2015 sales."
http://vitality.bio/2017/04/vitality-biopharma-appoints-pharma-industry-veteran-advance-cannabosides-regulatory-development/
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