Injectable Medication | Page 3 of 10

Sanofi’s Lyxumia Approved for Type 2 Diabetes Treatment in Japan

Japan's Ministry of Health, Labor and Welfare (MHLW) approved the manufacturing and distribution of Sanofi's new type 2 diabetes treatment, Lyxumia (lixisenatide) in Japan. Lyxumia, the first once daily prandial GLP-1 receptor agonist (RA), is also the first GLP-1 RA approved in Japan...

Biodel to Produce Glucagon Rescue Product

Biodel has announced plans to submit a New Drug Application (NDA) to the FDA in 2015 for a novel glucagon rescue device to treat severe hypoglycemia. Having previously signed a long-term commercial supply agreement for bulk glucagon, Biodel expects to select a final formulation of its novel glucagon therapy...

FDA To Re-Evaluate Type 2 Diabetes Drugs Following New Research

The FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.

FDA to Review NDA for Lixisenatide, Sanofi’s New Type 2 Diabetes Therapy

The FDA has accepted Sanofi's New Drug Application (NDA) for lixisenatide, the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes, for review. The acceptance of the lixisenatide NDA filing follows the February 1, 2013, European Commission approval of lixisenatide in the European Union.

Lyxumia, Sanofi’s Type 2 Diabetes Treatment, Approved in EU

The European Commission has granted Marketing Authorisation in Europe for Sanofi's new type 2 diabetes treatment, Lyxumia (lixisenatide). Lyxumia is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal.

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 ...

FDA approves Lucentis for Diabetic Macular Edema

The U.S. FDA has approved Roche's Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes. The FDA previously had approved Lucentis to treat wet (neovascular) age-related macular degeneration (AMD), a condition in which abnormal blood vessels grow and leak fluid into the macula. Lucentis also is approved to treat macular edema following retinal vein occlusion...