Monday, November 18, 2013
CRO WuXi PharmaTech, with operations in China and the U.S., said its subsidiary Shanghai SynTheAll (STA) Pharmaceutical has entered into a supply arrangement with Pharmacyclics. This follows a successful multiple-year development and clinical manufacturing partnership that supported Pharmacyclics with an expedited NDA submission and final approval by the FDA of Imbruvica on Nov. 13, for treatment of patients with mantle cell lymphoma who have received at least one prior therapy. This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established.