Category: Insulin

Glucose-Responsive-Insulin

Creating Glucose-Responsive Insulin: The Crowdsourcing Approach

From its isolation and first use in 1922, insulin has been called one of the few miracle drugs, saving diabetics from the early death of an untreatable disease. Any diabetic nowadays, however, will tell you-- insulin treatment for glucose control is a tricky business.
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Positive Phase 2 Results for Halozyme’s Ultra Fast Insulins

Halozyme Therapeutics, a San Diego based biopharmaceutical company, announced positive results from two Phase 2 clinical trials of its ultrafast PH20 insulin analog formulations in patients with type 1 and type 2 diabetes...
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FDA Approves Byetta for Use with Lantus Insulin in the U.S.

The U.S. Food and Drug Administration (FDA) has approved a new use for Amylin and Eli Lilly's type 2 diabetes drug, Byetta (exenatide) injection. Byetta is now approved as an add-on therapy to insulin glargine (Lantus), with or without metformin and/or a thiazolidinedione (TZD), for adults with type 2 diabetes...
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Novo Nordisk Requests FDA Approval for Ultra-Long-Acting Insulin Degludec

Novo Nordisk filed two new drug applications for the approval of ultra-long-acting insulin degludec and the co-formulation, insulin degludec/insulin aspart (DegludecPlus) by the U.S. Food and Drug Administration. These new insulin analogs have been developed for the treatment of people with type 1 and type 2 diabetes.
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Biodel’s Ultra Rapid Insulin Fails in Second Phase 1 Trial

Biodel's ultra-rapid-acting formulations of recombinant human insulin, BIOD-105 and BIOD-107, failed to meet the company's target product profile in the second phase 1 clinical trial at Oregon Health and Sciences University and will therefore not be advancing to phase 2 trials. The top-line results from the phase...
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Eu Adopts Positive Opinion on Levemir as an Add-On Therapy to Victoza in Type 2 Diabetes Patients

Following a review of new data from a 52-week clinical trial, the European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the usage of Novo Nordisk’s basal insulin analogue, Levemir, as add-on therapy to Novo Nordisk’s GLP-1 analogue, Victoza, in combination with metformin in patients with type 2 diabetes...
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Novo Nordisk

EU Finds Novo Nordisk’s Detemir Safe for Children Aged 2-5

The European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the extended use of Novo Nordisk’s basal insulin analogue, insulin detemir, in children with type 1 diabetes, aged two to five years. The CHMP decision was made after the review of data demonstrating that insulin detemir...
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Novo Nordisk’s New Ultra-Long-Acting Insulin Proves Effective for Treatment of Type 2 Diabetes

Novo Nordisk's ultra-long-acting insulin degludec, an investigational basal insulin being developed, showed significant blood sugar reductions in patients with type 2 diabetes even when doses were given once-daily up to 40 hours apart, according to data presented today at the European Association for the Study of Diabetes (EASD) in Lisbon...
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