Friday, July 31, 2015
GlaxoSmithKline (GSK) has received a positive opinion for its malaria vaccine candidate from the Committee for Medicinal Products for Human Use (CHMP) of the EMA. The vaccine candidate Mosquirix (RTS,S) is the first QS-21 Stimulon containing product to receive a positive regulatory decision.
Greenphire, a King of Prussia, Pa.-based provider of payment technologies for the clinical trials industry, has appointed Sue Vestri as chief financial officer. Vestri will be responsible for developing and driving the financial strategy for Greenphire, including working with the senior team to drive the company’s mission and help execute its growth plans.
The FDA has designated Progenics Pharmaceuticals’ Azedra as a Breakthrough Therapy for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma. Azedra currently is being evaluated in a pivotal phase IIb trial, which is being conducted under a Special Protocol Assessment Agreement (SPA), and has received Orphan Drug and Fast Track designations from the FDA.
Sanofi and Regeneron Pharmaceuticals have entered into a new global collaboration to discover, develop and commercialize new antibody cancer treatments in the emerging field of immuno-oncology. The two companies will jointly develop a programmed cell death protein 1 (PD-1) inhibitor currently in phase I testing, and plan to initiate clinical trials in 2016 with new therapeutic candidates based on ongoing, innovative preclinical programs.
Hikma Pharmaceuticals, a multinational pharmaceutical group, has agreed to acquire Boehringer Ingelheim Roxane and Roxane Laboratories from Boehringer Ingelheim. Roxane is a well-established U.S. specialty generics company with a highly differentiated product portfolio and best-in-class R&D capabilities.