An independent committee of medical experts of the FDA Advisory panel voted to recommend approval of SGLT2 inhibitor Dapagliflozin from Bristol-Myers Squibb (Now sold to Astra Zeneca) that U.S. regulators rejected two years ago due to safety concerns.

The advisory panel to the U.S. Food and Drug Administration said the benefits of the medicine appear to outweigh its risks. In another vote, the panel found the drug appeared to have a favorable cardiovascular safety profile.

An improved version of Sanofi's diabetes drug Lantus is better than the old one at controlling blood sugar levels and comes with fewer hypoglycemic events, according to new late-stage trial data. The detailed Phase III results unveiled at the World Diabetes Congress in Melbourne showed U300 was better than Lantus at controlling blood sugar lows at night, a common side effect in diabetics treated with insulin.

The drug also lowered the incidence of hypoglycemic events at any time of the day across the six-month study period. U300 met its goal in three other Phase III clinical trials, showing similar blood sugar level control as Lantus in patients with type 2 diabetes not previously treated with insulin and uncontrolled on oral medication, as well as in patients with type 1 diabetes already treated with insulin.

Echo Therapeutics, Inc., a medical device company developing its Symphony® CGM System as a non-invasive, wireless continuous glucose monitoring system, announced positive results from its multi-center clinical trial of the Symphony CGM System in surgical patients in hospital critical care units.

Symphony met the primary safety and effectiveness endpoints of the trial which involved the continuous monitoring of glucose levels in 32 subjects in the critical care units at four investigational sites. Using over 630 Symphony CGM glucose readings paired with reference blood glucose measurements in thirty-two (32) study subjects, CG-EGA showed that 97.9% of the readings were clinically accurate and 1.8% were benign errors, with a combined A+B value of 99.7%. The MARD (mean absolute relative difference) for the study was 12.5%. There were no adverse events reported from the skin preparation or the Symphony CGM sensor session. The range of glucose values was 49 - 324 mg/dL.