While Fiasp is now the only ultra fast insulin on the market, it won’t be the new kid for long. At least two other companies are hard at work bringing…
Tag: Rapid 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...
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 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...
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...
Halozyme Therapeutics, a San Diego based biopharmaceutical company, announced positive results from two Phase 2 clinical trials of its ultrafast PH20 insulin analog formulations in patients with type 1 and type 2 diabetes...
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 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 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...
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) requesting additional information regarding Biodel Inc.'s new drug application (NDA) for Linjeta a more-rapid-acting human insulin injection for the treatment of type 1 and type 2 diabetes.
The CRL stated that the FDA's review cycle is complete and that the application cannot be...