New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
August 12, 2014
07:48 EDTINSYInsys Therapeutics submits NDA for new formula of Dronabinol Oral Solution
Insys Therapeutics announced it has submitted a New Drug Application to the FDA for its proprietary Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS; and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol Oral Solution is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a synthetic version of tetrahydrocannabinol, or THC. Upon completion of the Phase III trial: Insys' Dronabinol Oral Solution demonstrated bioequivalence by using 4.25 mg of oral solution versus 5 mg of Marinol, suggesting patients may achieve similar clinical benefits with a lower dose of THC. All patients who took the oral solution achieved detectable plasma levels at 15 minutes, while less than 25% of Marinol patients achieved detectable plasma levels over the same duration. It took four hours for all Marinol subjects to achieve detectable plasma levels. The dronabinol oral solution compared to the Marinol arm also showed less intra patient variability by over 60 percent when measuring total patient exposure to THC. Insys conducts cannabinoid research and production in the United States at its advanced pharmaceutical-grade manufacturing facility, which is approved by the DEA and inspected by the FDA. The company is expanding its production capabilities to include an additional facility to meet anticipated demand once the FDA approves its pipeline products.
News For INSY From The Last 14 Days
Check below for free stories on INSY the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
September 15, 2014
12:58 EDTINSYInsys retreats after receiving second subpoena from U.S.
Subscribe for More Information
08:23 EDTINSYInsys subpoena should not overshadow bigger picture, says Wells Fargo
Subscribe for More Information
07:41 EDTINSYInsys new subpoena an extension of previous probe, says Oppenheimer
After Insys received a subpoena from the Department of Justice after previously receiving a subpoena from an Inspector General's office, the firm thinks the second subpoena is related to the same investigation as the first one. Oppenheimer views the second subpoena as a headline risk but does not expect it to impact the company's business. It keeps a $40 price target and Outperform rating on the shares.
September 12, 2014
18:03 EDTINSYInsys Therapeutics receives subpoena over Subsys sales, marketing practices
On September 8, Insys Therapeutics, Inc. received a subpoena issued pursuant to the Health Insurance Portability and Accountability Act of 1996, as amended, from the U.S. Attorney’s Office for the District of Massachusetts. The subpoena requests documents regarding Subsys, including Insys’ sales and marketing practices related to this product. Insys intends to cooperate with the investigation.
September 10, 2014
10:25 EDTINSYInsys Therapeutics management to meet with JMP Securities
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