Insulin Glargine News and Research

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Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

Biodel reports data on Linjeta formulation for type 1 diabetes at Technology Meeting in Bethesda

Scientists from Biodel Inc. reported new findings from the company's Linjeta, insulin glargine, "smart" basal insulin and stabilized glucagon development programs in poster presentations yesterday and today at the Tenth Annual Diabetes Technology Meeting in Bethesda, MD.

15 Nov 2010

Access submits additional patent applications for Cobalamin-mediated oral drug delivery technology

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced it has submitted additional patent applications, covering its Cobalamin-mediated oral drug delivery technology formulations of many global top-100 injectable drugs, as a result of the growing interest surrounding the company's proprietary oral delivery technology.

21 Oct 2010

Biocon, Pfizer enter global agreement to commercialize Insulin analog products

Biocon, Asia's premier biotechnology company, and Pfizer Inc. (NYSE: PFE), the world's leading biopharmaceutical company, today announced that they have entered into a strategic global agreement for the worldwide commercialization of Biocon's biosimilar versions of Insulin and Insulin analog products: Recombinant Human Insulin, Glargine, Aspart and Lispro.

18 Oct 2010

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, is pleased to note that its partner, sanofi-aventis, has today announced positive top-line results of the Phase III GETGOAL-L-ASIA trial which assessed the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist discovered by Zealand Pharma, in combination with basal insulin.

30 Sep 2010

Sanofi-aventis releases Lantus(R) study results for type 2 diabetes

Sanofi-aventis announced today results of two studies presented at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden.

20 Sep 2010

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

Amylin Pharmaceuticals, Inc. today reported financial results for the quarter ended June 30, 2010. The Company reported total revenue of $164.4 million for the quarter ended June 30, 2010, which includes net product sales of $162.5 million. Net loss, excluding a restructuring charge of $3.4 million, was $40.8 million, or $0.28 per share.

22 Jul 2010

Biodel reports preclinical test results of BIOD620 glucose-regulated or "smart" basal insulin product candidate

Biodel Inc. today reported results of preclinical tests which demonstrated the potential of the company's glucose-regulated or "smart" basal insulin product candidate, BIOD620, to release insulin proportionally in response to changing glucose conditions. In an oral presentation today at the 37th Annual Meeting and Exposition of the Controlled Release Society in Portland, Oregon, Nandini Kashyap, director of novel drug delivery at Biodel, described results of in vitro and in vivo studies with diabetic pigs which compared the use of BIOD620 to Lantus® (insulin glargine).

13 Jul 2010

Amylin presents improved indices of beta-cell function after three years of BYETTA(R) therapy

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from a study comparing the effect of long-term treatment with either BYETTA® (exenatide) injection or Lantus® (insulin glargine) on overall beta-cell function. (Beta cells are cells in the pancreas that produce insulin.) Three years of BYETTA therapy improved indices of beta-cell function assessed four weeks after discontinuing therapy. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.

30 Jun 2010

Lantus and Apidra improve outcomes, decrease glycemic variability: Study

Sanofi-aventis announced today results of a study which demonstrated that patients using Lantus® (insulin glargine [rDNA origin] injection) once-daily and Apidra® (insulin glulisine [rDNA origin] injection) before meals reported improved patient reported outcomes and decreased glycemic variability versus premix analog insulin. Two abstracts from this study were highlighted at the American Diabetes Association's 70th Annual Scientific Sessions (ADA).

29 Jun 2010

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA (exenatide) injection added to Lantus (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

Final results of VIAject vs. RHI Phase 3 study in type 2 diabetes patients presented at 70th ADA

The final results of a six-month, multi-center, open-label Phase 3 study of VIAject® (more-rapid-acting injectable human insulin) versus regular human insulin (RHI) in 471 patients with type 2 diabetes were presented today by Helena Rodbard, M.D., at the 70th Scientific Sessions of the American Diabetes Association. Dr. Rodbard was a principal investigator of this study, which was designed to evaluate the safety and efficacy of VIAject® versus regular human insulin when used in combination with insulin glargine.

28 Jun 2010

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

Ipsen a global biopharmaceutical group, today announced that its partner Roche disclosed results of five Phase III 24-week studies for taspoglutide for type 2 diabetes at the American Diabetes Association's (ADA) 70th Annual Scientific Sessions. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen's research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.

28 Jun 2010

Phase 2 proof-of-concept data for Novo Nordisk's degludec presented at ADA 2010

Novo Nordisk today presented phase 2 proof-of-concept data for its investigational insulin degludec, an ultra-long-acting basal insulin, which demonstrated the potential to help achieve target glycemic control when used once daily or three times weekly. These data were presented at the 70th Scientific Sessions of the American Diabetes Association.

28 Jun 2010

Lantus and Apidra injections improve glycemic control, reduce hospital complications: Study

Sanofi-aventis announced today that results from the RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes Undergoing General Surgery (RABBIT-2 Surgery) found that treatment with a basal-bolus regimen that included Lantus (insulin glargine [rDNA origin] injection) once-daily and Apidra (insulin glulisine [rDNA origin] injection) before meals improved glycemic control and reduced hospital complications, compared to "sliding scale" insulin in general surgery patients with type 2 diabetes.

28 Jun 2010

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

Amylin Pharmaceuticals, Inc. today announced that the Company will present data for its FDA-approved diabetes drugs, BYETTA (exenatide) injection and SYMLIN (pramlintide acetate) injection, and its investigational diabetes drug candidate BYDUREON (exenatide extended-release for injectable suspension) at the American Diabetes Association's 70th Annual Scientific Sessions being held in Orlando, FL from June 25 to June 29.

18 Jun 2010

Roche implements risk mitigation plan in taspoglutide Phase III programme

Ipsen, a global biopharmaceutical group, today announced that its partner Roche today announced the implementation of a risk mitigation plan in the taspoglutide Phase III programme. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen's research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.

18 Jun 2010

AFREZZA non-inferior to standard therapy insulin lispro in reducing HbA1c levels of Type 1 diabetics

MannKind Corporation today announced that results of a new 16-week trial show that the investigational ultra rapid acting mealtime insulin, AFREZZA™ (insulin human [rDNA origin]) Inhalation Powder, combined with basal insulin, is clearly non-inferior to standard therapy insulin lispro, a rapid acting insulin, also combined with basal insulin, in reducing HbA1c levels in subjects with inadequately controlled Type 1 diabetes.

11 Jun 2010

Health Canada approves Victoza for treatment of adults with type 2 diabetes

Diabetes is growing at an alarming rate in Canada, with an estimated 3.7 million people expected to be diagnosed by 2020. It is a progressive disease that, if not properly monitored and managed over time, will lead to serious long term complications. Canadians now have a novel treatment available to help them maintain optimal blood glucose levels. Health Canada has approved Victoza (liraglutide), the first GLP-1 analogue, for once-daily administration for the treatment of adults with type 2 diabetes to improve glycemic control in combination with metformin or metformin and a sulfonylurea.

27 May 2010

Additional benefits of LAIAs over long-acting human insulin not been proven

It has so far not been proven that the long-acting insulin analogues (LAIAs) insulin detemir (trade name: Levemir) and insulin glargine (trade name: Lantus), which are approved for the treatment of type 1 diabetes, offer patients an additional benefit versus long-acting human insulin. This applies to adults as well as to children and adolescents. This is the result of the final report published by the Institute for Quality and Efficiency in Health Care (IQWiG) on 19 April 2010.

13 May 2010

Insulin Glargine News and Research

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Biodel reports data on Linjeta formulation for type 1 diabetes at Technology Meeting in Bethesda

Access submits additional patent applications for Cobalamin-mediated oral drug delivery technology

Biocon, Pfizer enter global agreement to commercialize Insulin analog products

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

Sanofi-aventis releases Lantus(R) study results for type 2 diabetes

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

Biodel reports preclinical test results of BIOD620 glucose-regulated or "smart" basal insulin product candidate

Amylin presents improved indices of beta-cell function after three years of BYETTA(R) therapy

Lantus and Apidra improve outcomes, decrease glycemic variability: Study

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Final results of VIAject vs. RHI Phase 3 study in type 2 diabetes patients presented at 70th ADA

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

Phase 2 proof-of-concept data for Novo Nordisk's degludec presented at ADA 2010

Lantus and Apidra injections improve glycemic control, reduce hospital complications: Study

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

Roche implements risk mitigation plan in taspoglutide Phase III programme

AFREZZA non-inferior to standard therapy insulin lispro in reducing HbA1c levels of Type 1 diabetics

Health Canada approves Victoza for treatment of adults with type 2 diabetes

Additional benefits of LAIAs over long-acting human insulin not been proven

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