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January 19, 2013

  FDA Advisory Committee Recommends Approval of First in Class SGLT-2(Canagliflozin). Next Once Weekly GLP-1 (albiglutide) Submitted to FDA for Approval. Looking for 10,000 seniors to participate in a free program to prevent diabetes (See Item #2).

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FDA launches “Bad Ad Program” to detect misleading drug ads

FDA Launches Next Stage of "Bad Ad Program" to Detect Misleading Drug Ads. The program is designed to educate healthcare providers about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading. For more information visit www.fda.gov/badad. New Next-generation OmniPod® Approved by FDA. The new …

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Metformin Possible Treatment for Ovarian Cancer

Metformin Possible Treatment for Ovarian Cancer. See this week’s Item #3, Diabetes Drug Metformin May Fight Ovarian Cancer. Novo Nordisk: Ryzodeg(R) (insulin degludec/insulin aspart) passed the review by the First Committee on Drugs of Pharmaceutical Affairs in Japan.

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FDA Panel Approves Degludec

An advisory panel to the U.S. Food and Drug Administration approved Novo’s Insulin Degludec, but…. See this week’s Item #3, Novo’s Insulin Degludec Wins FDA Panel Approval.

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Levemir® Label Update

Levemir® Label Update Levemir® (insulin detemir [rDNA origin] injection) has been approved for use in combination with metformin and a GLP-1 receptor agonist. In the study, when Levemir® once daily added on to metformin + Victoza, 50% of patients reached A1c goal <7%. 

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Degludec Insulin Gets EU Backing

Degludec Insulin Gets EU Backing Novo Nordisk’s ultra-long-acting insulin Tresiba has been recommended for approval by the European Medicines Agency in an important boost for the Danish drugmaker’s key new product. See this week’s Item #6. First Non-Invasive CGMS Gets CE Mark Approval for People with Diabetes. C8 MediSensors Optical …

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