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May 6, 2014
07:21 EDTINSYInsys Therapeutics to advance development of CBD to treat epilepsy
Insys Therapeutics announced plans to advance development of its pharmaceutical Cannabidiol, or CBD, a synthetically produced and over 99% pure form of cannabidiol, to treat epilepsy in children and adults. Insys has engaged a large international Clinical Research Organization to provide development and regulatory services and has hired Mark Davis as Senior Clinical Director to oversee this program. Insys plans to file an Investigational New Drug application with the FDA in the second half of 2014 for CBD for the treatment of epilepsy. In pediatrics, Insys plans to pursue development of treatments for Lennox-Gastaut Syndrome and Dravet Syndrome, which are orphan indications.
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August 25, 2014
09:11 EDTINSYOn The Fly: Pre-market Movers
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07:07 EDTINSYInsys Therapeutics receives FDA orphan drug designation for CBD
Insys Therapeutics announced that the FDA has granted orphan drug designation to its pharmaceutical cannabidiol, or CBD, for the treatment of glioblastoma multiforme, or GBM, the most common and most aggressive malignant primary brain tumor in humans. In addition to receiving orphan drug designation, Insys has recently entered into an exclusive licensing agreement with California Pacific Medical Center on behalf of its Research Institute, or CPMCRI, based in San Francisco to license CPMCRI's patent rights related to the usage of cannabinoids for the treatment of GBM.

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