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August 25, 2014
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.
News For INSY From The Last 14 Days
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August 27, 2015
17:08 EDTINSYInsys Therapeutics receives purported service of notice of three IPR petitions
On August 26, Insys Therapeutics received purported service of notice of three inter partes review petitions filed by a hedge fund with the U.S. Patent and Trademark Office, challenging three of the four Orange Book-listed patents covering Subsys. The company intends to oppose the request to institute the IPR and, if any of the three petitions are granted, the company intends to defend the validity of each patent challenged in each IPR.
August 18, 2015
08:16 EDTINSYInsys Therapeutics files citizen petition with DEA to reschedule synthetic CBD
Insys Therapeutics announced it has filed a Citizen Petition with the DEA to request the agency reschedule its synthetic pharmaceutical cannabidiol, or CBD, from Schedule I to Schedule IV. The company believes that the current classification of synthetic CBD as a Schedule I compound is a significant barrier to the progress of research studies that explore the value of this compound in the treatment of several serious medical conditions.
August 17, 2015
12:24 EDTINSYInsys dronabinol oral solution NDA accepted for filing by FDA
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