Category: Products & Tech

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Degludec, Novo Nordisk’s New Insulin, On Its Way To FDA Approval

The Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) completed its meeting regarding the New Drug Applications (NDA) for Novo Nordisk's insulin degludec (to be marketed under the name Tresiba) and insulin degludec/insulin aspart.
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EU Panel Backs Novo Nordisk’s Tresiba

The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted positive opinions, recommending marketing authorizations, for Novo Nordisk's new insulin Tresiba and insulin Ryzodeg for the treatment of diabetes mellitus in adults. Tresiba , the intended brand name for insulin degludec, is a new generation of once-daily basal insulin. In "treat-to-target? studies supporting the new drug application, where Tresiba was compared to insulin glargine,
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New Dexcom G4 PLATINUM Approved by FDA

The U.S. FDA has approved Dexcom's new continuous glucose monitoring system, the Dexcom G4™ PLATINUM. According to clinical trials the new Dexcom G4 PLATINUM has much improved accuracy with up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range. The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.
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Hypoglycemia Common Among Type 2 Diabetes Patients Treated with Insulin

According to the GAPP2™ (Global Attitudes of Patients and Physicians) survey, funded by Novo Nordisk and presented today at the Annual Meeting of the European Association for the Study of Diabetes (EASD), four out of five (80%) people with type 2 diabetes have experienced self-treated hypoglycemia...
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Novo Nordisk’s Ultra-Long Acting Insulin, Tresiba, Approved in Japan

The Japanese Ministry of Health, Labour and Welfare has approved Novo Nordisk's ultra-long acting insulin, insulin degludec, for treatment of diabetes. Insulin degludec, marketed globally under the name Tresiba, is a new generation of once-daily basal insulin, which has been discovered and developed by Novo Nordisk.
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Zealand Pharma Begins Phase 1 Study of Type 2 Diabetes Drug

Zealand Pharma, a Danish biotechnology company dedicated to the discovery and development of innovative peptide drugs, announced the start of the first Phase I clinical study of ZP2929. ZP2929 is a dual acting glucagon/GLP-1 peptide agonists, invented by Zealand Pharma and with global rights out-licensed to Boehringer Ingelheim as part of a global license and research ...
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Biodel Initiates a Phase 2 Study of Ultra-Rapid-Acting Insulin

Biodel has initiated a Phase 2 clinical trial of its proprietary recombinant insulin (RHI)-based ultra-rapid-acting mealtime insulin candidate, BIOD-123. The study is designed to assess the clinical impact of the ultra-rapid absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogs. In April 2012, Biodel announced positive top-line results from a Phase 1 clinical trial of BIOD-123, which demonstrated that the formulation had a more rapid absorption...
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