New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
December 6, 2012
16:02 EDTBIODBiodel: FDA grants orphan drug designation for Glucagon
Biodel announced that the FDA has granted orphan drug designation for Biodel's 'glucagon' for the prevention of hypoglycemia in the congenital hyperinsulinism population. The FDA grants orphan designation to promote development of therapies to treat rare diseases. Once this designation is granted, the sponsor may be eligible for a range of incentives including FDA grant funding for clinical trial costs, tax credits related to development expenses, waiver of FDA user fees, and a seven-year period of marketing exclusivity in the U.S. following FDA approval.
News For BIOD From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
March 19, 2015
16:59 EDTBIODBiodel files to sell $30M of common stock
March 16, 2015
07:27 EDTBIODBiodel BIOD-961 Phase 1 clinical trial meets primary efficacy endpoint
Biodel (BIOD) announced positive preliminary results from Study 6-101, a Phase 1 clinical trial comparing Biodel's lyophilized glucagon formulation BIOD-961, designed for use in a proprietary Glucagon Emergency Management, or GEM, auto-reconstitution device, to Eli Lilly's (LLY) Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit, which are marketed for the treatment of severe hypoglycemia. Study 6-101 was a randomized, single-center, double blind, six-period cross over study in 15 healthy volunteers who received each glucagon administered subcutaneously, or SC, and intramuscularly, or IM, in a randomized treatment sequence. The objectives of the study were to compare the pharmacokinetic, or PK, profiles, the pharmacodynamic, or PD, glucose, responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. Study 6-101 was a Phase 1 randomized, single-center, double blind, six-period cross over study designed to evaluate the PK and PD profiles of BIOD-961 compared to marketed glucagon formulations manufactured by Eli Lilly and Novo Nordisk. BIOD-961 is a lyophilized glucagon formulation designed for use in the GEM auto-reconstitution device. On six separate dosing days, each subject received 1 mg of one of the test glucagons delivered either SC or IM. Fifteen normal, healthy subjects were randomized into the study and ten completed all dosings. The objectives of the study were to compare the PK profiles, the PD responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. These data will facilitate selection of an appropriate marketed glucagon to use as a comparator in the planned pivotal study, in which the primary efficacy endpoint for approval is to demonstrate PK and PD bioequivalence of BIOD-961 to one of the marketed comparators.

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