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Medtronic Receives FDA Approval for Diabetes Management System

Medtronic, Inc. announced it has received U.S. Food and Drug Administration (FDA) approval for the MiniMed Paradigm® REAL-Time Revel™ System, an integrated diabetes management system which combines insulin pump therapy, continuous glucose monitoring (CGM) and diabetes therapy management software...

New Type 2 Diabetes Drug May Be On The Way

An Ohio State University study found that an experimental oral drug lowers blood sugar levels and inflammation in mice with type 2 diabetes, suggesting that the medication could someday be used to treat humans with type 2 diabetes. The drug consists of a synthetic molecule that stops the biological activity of a protein called macrophage...

European Artificial Pancreas On The Way

According to a JDRF press release, a consortium of academic and industrial partners has announced a collaboration called AP@home that aims to develop an artificial pancreas which would allow automated glucose control for people with insulin treated diabetes. In the first phase of the AP@home project, currently available AP algorithms will be tested with CGM (continuous glucose monitoring) systems and insulin pumps...

Amylin, Lilly and Alkermes Receive FDA Complete Response Letter for Exenatide Once Weekly

Amylin Pharmaceuticals Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM). In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes. The companies view this response as a positive step forward...

FDA Requests Additional Information From Mannkind Corp. Regarding AFREZZA

MannKind Corporation announced that it has received a Complete Response letter from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA(TM) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes...

FDA Accepts Biodel’s New Drug Application for Review

Biodel Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company's new drug application seeking approval to market VIAject(R) for the treatment of diabetes. VIAject(R) is Biodel's proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs...

First Governmental Lawsuit Against GSK Over Avandia

On Friday over its diabetes drug Avandia, charging a decade of false advertising and seeking compensation on behalf of patients and providers in California. MercuryNews reports the county claims the drugmaker made billions of dollars on Avandia, which caused heart attacks and strokes....

Lilly and Amylin Confirm FDA Extension of Exenatide Once Weekly New Drug Application Review

The Food and Drug Administration (FDA) announced that following the closure of FDA building due to extreme weather it was granting a five day extension for the review of Amylin Pharmaceuticals Inc and Eli Lilly and Co's Exenatide Once Weekly New Drug Application. The new drug is part of a collaboration between the companies started in 2002, which includes the currently available twice daily type 2 diabetes drug...

GSK Rejects Allegation Regarding Avandia Safety

GlaxoSmithKline (GSK) responded to the recently released Senate Committee on Finance report regarding Avandia. GSK said it rejects any allegations of concealing safety information or acting inappropriately on behalf of patients. GSK also said it disagrees with the Committee’s decision to publish a Staff Report with the errors of fact, omissions, and inferences detailed in GSK’s White Paper....

FDA Advises Patients To Continue Taking Avandia

The Food and Drug Administration (FDA) announced it would be reviewing data submitted in August 2009, from a large, long-term clinical study (RECORD study) on possible risks associated with the diabetes drug, Avandia (rosiglitazone). The FDA said it will complete its review of the data from the RECORD study, and will then...