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European Commission grants marketing authorization for use of BYETTA with basal insulin

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced today that the European Commission has granted marketing authorization to BYETTA (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or Actos (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.

23 Mar 2012

BYETTA-basal insulin combination therapy receives EMA CHMP positive opinion

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion in the European Union for the expanded use of BYETTA (exenatide twice-daily) as an add-on therapy to basal insulin, with or without metformin and/or Actos (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.

17 Feb 2012

Amylin and Lilly terminate exenatide alliance, resolve litigation

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced an agreement to terminate their alliance for exenatide and resolve the outstanding litigation between the companies.

9 Nov 2011

Lantus initiation may help limit weight gain in type 2 diabetes patients

Sanofi announced today data that demonstrates that initiating Lantus® (insulin glargine [rDNA origin] injection) in type 2 diabetes patients leads to better glycemic control and comparable and modest weight gain versus a comparator group consisting of other insulins, oral antidiabetics and dietary changes.

12 Sep 2011

First-ever comprehensive study of species origins of nature-derived drugs

In a first-ever comprehensive study of the species origins of nature-derived drugs, it is shown that drug-producing species are concentrated and clustered in a limited number of families, refuting the conventional view that as every nature species produces biologically active molecules, one can find drugs from almost any major block of species groups if one looks for them hard enough.

8 Sep 2011

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

Study: Mixing exenatide with insulin provides better blood sugar control in type 2 diabetes patients

A new study finds that combining the newer diabetes drug exenatide with insulin provides better blood sugar control in patients with type 2 diabetes than insulin alone and helps promote weight loss.

7 Dec 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

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

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

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

Pfizer to maintain top spot in prescription sales through mergers and acquisitions

The rheumatoid arthritis treatment Humira will replace Lipitor as the world's biggest-selling drug in 2016, but a familiar name, Pfizer, will still be the biggest seller of medicines after the patent cliff according to the World Preview 2016 report published today by EvaluatePharma, the premier provider of pharma and biotech analysis.

3 May 2010

AgaMatrix, sanofi-aventis announce long-term partnership for BGM solutions

AgaMatrix, Inc. and sanofi-aventis today announced that they have signed a long-term agreement for the development, supply and commercialization of blood glucose monitoring (BGM) solutions. Under the terms of the agreement, AgaMatrix and sanofi-aventis will co-develop innovative solutions in diabetes management that incorporate AgaMatrix's WaveSense™ technology. Sanofi-aventis will commercialize through its Global Diabetes Division such integrated solutions for patients with diabetes, along with current sanofi-aventis insulins and delivery devices.

31 Mar 2010

NexACT technology demonstrates ability to deliver Taxol subcutaneously

NexMed, Inc., a specialty CRO and a developer of products based on the NexACT® technology, today announced that pre-clinical results from the research and development group at its Bio-Quant subsidiary have successfully demonstrated the ability of the NexACT technology to deliver insulin and other large molecule drugs such as Taxol subcutaneously, in a depot-like fashion (or slow release) over a 24 hour period from a single injection.

18 Mar 2010