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GSK Halts Enrollment in Avandia Study at FDA Request

GlaxoSmithKline confirmed today that it will suspend enrollment of new patients in the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) clinical trial at the request of the U.S. Food and Drug Administration (FDA) pending FDA review of recommendations from its Advisory Committee meeting July 13-14...

FDA Sends Warning Letter To Abbott Diabetes Unit

The Food and Drug Administration (FDA) warned Abbott Laboratories' (ABT) diabetes unit about manufacturing violations involving the company's blood-glucose-monitoring systems, according to a report published on NASDAQ.com...

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...

GlaxoSmithKline Issues Statement in Response to FDA Advisory Committee Vote on Avandia

GlaxoSmithKline confirmed that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow the diabetes drug Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions...

Diabetes Drug Maker Hid Study Data

Avandia Safety Questioned: The New York Times reports that diabetes drug maker SmithKline did not reveal the results of a study showing its drug Avandia was riskier to the heart than a competing drug, Actos. The New York Times states, "instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not ...

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...

Avandia Recall Possible: FDA Reviews

The diabetes drug, Avandia, may be more dangerous than was previously reported. According to CNN, a review of Avandia released last week by the FDA states that officials overseeing GlaxoSmithKline Plc’s RECORD study repeatedly submitted sloppy data and failed to follow up on reports of problems in patients -- including reports of patient deaths...

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...