Products & Tech | Page 43 of 63

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.

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...

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...

ALR Tech Receives FDA Clearance for Remote Monitoring System for Diabetes

ALR Technologies Inc received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Health-e-Connect (HeC) System for remote monitoring of patients in support of effective diabetes management programs. The 510(k) clearance enables the company to commence with the United States marketing and sales launch of its HeC platform...

Victoza, Novo Nordisk’s Type 2 Diabetes Drug, Available in China

Victoza, Novo Nordisks best selling type 2 diabetes drug is now commercially available in China. Victoza, (liraglutide injection), the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analog, was approved for type 2 diabetes by the Chinese State Food and Drug Administration in March 2011...

FDA Approves New Combination Drug, Juvisync, for Treatment of Type 2 Diabetes

The FDA has approved a new treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of JANUVIA, with the cholesterol-lowering medication ZOCOR (simvastatin). The new drug, produced by Merck, known as MSD outside the United States and Canada, will be...

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.

New Roche Accu-Chek Aviva Plus Glucose Test Strips Receive FDA Clearance

Roche announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Accu-Chek Aviva Plus test system. The new maltose-independent test strip is designed to prevent the interference of maltose on blood sugar readings which can occur in rare cases...

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...

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...