Insulin | Page 14 of 16

FDA Issues Complete Response Letter to Biodel New Diabetes Drug Application

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...

Is Insulin Enough? Developing C-Peptide Therapy

Cebix Incorporated, based in San Diego, California, has started looking at another missing component of beta cell secretion: C-peptides.

One in Three Patients Fail to Take Insulin as Prescribed

More than one in three diabetes patients skip doses or fail to take their insulin as prescribed, stating that they have done so on average three times in the last month, and 77 percent of physicians estimate that in reality this number could be as high as six doses*, according to the Global Attitudes of Patients...

Novo Nordisk’s Ultra- Long- Acting Insulin Shows Lower Day-to-Day Variability Compared to Lantus

Novo Nordisk presented clinical pharmacology data for insulin degludec, an ultra-long-acting basal insulin currently under clinical investigation. The data demonstrate up to four times lower day-to-day variability in the total metabolic effect compared to insulin glargine (Lantus) in people with type 1 diabetes. The data were presented at the 46th Scientific Sessions of the European Association for the Study of Diabetes (EASD)...

FDA Accepts AFREZZA Complete Response Resubmission and Sets Target Action Date

MannKind Corporation announced that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted, MannKind's resubmission of its New Drug Application (NDA) for AFREZZA(TM) (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding...

Biodel Reports Progress in Development of Glucose-Regulated ‘Smart’ Basal Insulin

Biodel Inc. reported results of preclinical tests which demonstrated the potential of the company's glucose-regulated or "smart" basal insulin product candidate, BIOD620, to release insulin proportionally in response to changing glucose conditions. In an oral presentation today at the 37th Annual Meeting and Exposition of the Controlled Release Society in Portland...

JDRF Grants $407,000 to Evaluate Use of Biodel’s VIAject(R) in Treatment of Diabetes

Biodel Inc. announced the award of two research grants by the Juvenile Diabetes Research Foundation (JDRF) to Stanford University and Oregon Health & Science University (OHSU) to evaluate the use of VIAject(R) (ultra-rapid-acting injectable human insulin) in the treatment of diabetes. The first grant will support clinical testing under the direction...

Better, Faster, Stronger: Creating Ultra-Rapid Insulin

The clear disparity between native, pancreatic insulin and the currently available synthetic insulins leaves a lot to be desired...

Gradual Addition of NovoLog® at Mealtime Can Reduce A1c in Type 2 Diabetes Patients

Novo Nordisk announced results of its STEPwise™ trial, which identified a method of intensifying insulin treatment with NovoLog® (insulin aspart [rDNA origin] injection). The study, presented at the American Diabetes Association (ADA) 2010 Scientific Sessions, demonstrated a reduction of A1c levels in type 2 diabetes patients when a dose of NovoLog® was introduced at meals, using two approaches that start with the largest meal of...

Byetta Improves Beta-Cell Function in Type 2 Diabetics

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced results from a study comparing the effect of long-term treatment with either Byetta (exenatide) injection or Lantus(R) (insulin glargine) on overall beta-cell function. Three years of Byetta therapy...