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News Breaks
July 1, 2014
11:05 EDTINSYInsys Therapeutics treatment of Dravet syndrome granted orphan status
Insys Therapeutics' cannabidiol was designated for orphan designation as a treatment of Dravet syndrome, according to a post to the FDA's website. Reference Link
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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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