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August 11, 2014
07:24 EDTBIODBiodel BIOD-531 demonstrates superior glucose control after meals
Biodel announced positive preliminary results from Study 3-152, a Phase 2a clinical trial comparing Biodel's proprietary, concentrated insulin formulation BIOD-531 to Humalog Mix 75/25 and Humulin R U-500 in patients with type 2 diabetes with moderate insulin resistance who use between 50 and 200 units of insulin per day. BIOD-531 was associated with superior glucose control compared to Humalog Mix 75/25 throughout the day of observation. BIOD-531 was also associated with superior glucose control compared to Humulin R U-500. BIOD-531 dosed 20 minutes after the start of the standardized breakfast also resulted in superior glucose control compared to either Humalog Mix 75/25 or Humulin R U-500 dosed prior to the meal. Mean visual analog scores and absolute severity scores were low for all participants, suggesting excellent injection site tolerability.
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December 17, 2014
16:01 EDTBIODBiodel reports Q4 EPS (66c), consensus (25c)
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December 4, 2014
16:25 EDTBIODBiodel initiates proof of concept study in Glucagon Emergency Management program
Biodel has initiated enrollment of normal human subjects in a Phase 1 clinical trial of its lyophilized glucagon formulation designed for use in a proprietary auto-reconstitution device intended for the rescue of patients with severe hypoglycemia. The combination of the formulation and the auto-reconstitution device constitutes the Glucagon Emergency Management system, which is intended to be a more user-friendly glucagon presentation compared to emergency kits currently marketed. Biodel expects to report top line results of the Phase 1 proof of concept GEM study in late 1Q15.

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