New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 25, 2014
07:07 EDTINSYInsys receives FDA orphan drug designation for pharmaceutical cannabidiol
Insys Therapeutics announced that the U.S. Food and Drug Administration has granted orphan drug designation to its pharmaceutical cannabidiol for the treatment of Lennox-Gastaut Syndrome, a rare pediatric-onset epilepsy. The company said, "We have the unique opportunity to test a controlled pharmaceutical CBD product for Lennox-Gastaut Syndrome, and our company is committed to advancing cannabinoid therapies that have the potential to provide significant medical benefits to patients across multiple indications. We expect to file an Investigational New Drug Application for CBD in 2H14."
News For INSY From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
October 16, 2014
09:02 EDTINSYInsys Therapeutics weakness creates buying opportunity, says JMP Securities
Subscribe for More Information
October 15, 2014
18:26 EDTINSYOn The Fly: After Hours Movers
Subscribe for More Information
16:34 EDTINSYInsys Therapeutics receives DEA approval to produce pharmaceutical Cannabidiol
Insys Therapeutics announced that its FDA inspected and Drug Enforcement Agency approved facility in Round Rock, Texas, has received DEA approval to manufacture synthetically its pharmaceutical grade Cannabidiol. The company has also been granted a quota to produce 15kg of CBD in 2014 and expects a larger quota in 2015 for its continued clinical studies. Insys believes these quantities are sufficient to pursue its CBD development program as currently planned. Insys held a pre-IND meeting with the FDA in September 2014 regarding its development program for CBD in pediatric patients suffering from Dravet Syndrome and Lennox-Gastaut Syndrome, two rare forms of pediatric epilepsy. Insys projects to file an IND in December 2014 for these indications. Babich also noted that Insys has compared its pharmaceutical CBD, which is synthetically produced, with plant-derived CBD obtained from the National Institute on Drug Abuse (NIDA), and found both materials contain an identical chemical structure. "We are pleased that testing in our laboratories has confirmed our long-standing belief that our pharmaceutical CBD is the chemical structure of plant-derived CBD and we believe our purity levels will provide consistent material in the clinical programs," Babich concluded.
16:31 EDTINSYInsys Therapeutics provides update on Dronabinol Oral Solution NDA
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use