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Biodel to Produce Glucagon Rescue Product

Biodel has announced plans to submit a New Drug Application (NDA) to the FDA in 2015 for a novel glucagon rescue device to treat severe hypoglycemia. Having previously signed a long-term commercial supply agreement for bulk glucagon, Biodel expects to select a final formulation of its novel glucagon therapy...

Biodel Initiates a Phase 2 Study of Ultra-Rapid-Acting Insulin

Biodel has initiated a Phase 2 clinical trial of its proprietary recombinant insulin (RHI)-based ultra-rapid-acting mealtime insulin candidate, BIOD-123. The study is designed to assess the clinical impact of the ultra-rapid absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogs. In April 2012, Biodel announced positive top-line results from a Phase 1 clinical trial of BIOD-123, which demonstrated that the formulation had a more rapid absorption...

NIH Awards Biodel Grant to Develop Ultra-Rapid-Acting Insulin for Use in Artificial Pancreas

The Small Business Innovation Research (SBIR) program of the National Institutes of Health (NIH) has awarded Biodel a grant for the development of concentrated ultra-rapid-acting insulin formulations for use in an artificial pancreas, also known as a closed loop pump system.

Biodel Obtains Technologies for Development of Glucagon Formulations

Biodel Inc. has partnered with Aegis Therapeutics, LLC (Aegis) and has obtained exclusive worldwide license to Aegis' proprietary ProTek and Intravail technologies for the development and commercialization of pharmaceutical formulations of glucagon...

Positive Results for Biodel’s Ultra Rapid Acting Insulin

Biodel Inc. announced positive top-line results from a Phase 1 clinical trial of its product candidates, BIOD-123 and BIOD-125 -- two proprietary ultra rapid acting formulations of recombinant human insulin (RHI). The objective of the trial was to identify...

Biodel’s Ultra Rapid Insulin Fails in Second Phase 1 Trial

Biodel's ultra-rapid-acting formulations of recombinant human insulin, BIOD-105 and BIOD-107, failed to meet the company's target product profile in the second phase 1 clinical trial at Oregon Health and Sciences University and will therefore not be advancing to phase 2 trials. The top-line results from the phase...

Biodel’s Ultra-Rapid-Acting Insulin Formulations to be Tested in Patients Using Insulin Pumps

Biodel announced that an independent investigator initiated a pump trial of Biodel's two ultra-rapid-acting formulations of recombinant human insulin. Biodel's formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed mealtime insulin analogs...

Biodel to Accelerate Development of Ultra-Rapid-Acting Insulins

Biodel Inc. has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates. The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed...