Diabetic Ketoacidosis News and Research

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Diabetic ketoacidosis – (DKA) or diabetic coma occurs when a diabetic does not properly balance their insulin intake with their diet or activity.

Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

28 Jul 2011

Exenatide tQT clinical trial meets pre-specified primary endpoint

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced results from a thorough QT (tQT) study that assessed the potential of exenatide to increase the QT interval across a wide range of plasma concentrations.

8 Jul 2011

New data from JANUMET clinical study on type 2 diabetes presented at ADA 2011

In a new post-hoc analysis based on the American Association of Clinical Endocrinologists (AACE/ACE) diabetes algorithm presented at the American Diabetes Association (ADA) 71st Annual Scientific Sessions, significantly more patients with type 2 diabetes treated with JANUMET-tablets achieved blood sugar goals after 18 weeks compared to metformin as initial therapy.

27 Jun 2011

EMA CHMP recommends approval of linagliptin for type 2 diabetes

Boehringer Ingelheim and Eli Lilly and Company today received a positive opinion from the European Medicines Agency's (EMA) medicinal committee recommending approval of linagliptin, 5 mg, film-coated tablets (to be marketed under the trade name Trajenta® in Europe) for the treatment of adults with type 2 diabetes.

24 Jun 2011

EC grants marketing authorization to BYDUREON for treatment of type 2 diabetes

Eli Lilly and Company, together with Amylin Pharmaceuticals, Inc. and Alkermes, Inc., announced today that the European Commission has granted marketing authorization to BYDUREON.

21 Jun 2011

Amylin to present data on investigational diabetes drug candidates at ADA annual meeting

Amylin Pharmaceuticals, Inc. today announced that the Company will present data for its two first-in-class diabetes drugs, BYETTA injection and SYMLIN injection, and its investigational diabetes drug candidates BYDUREON and exenatide once monthly at the 71st Scientific Sessions of the American Diabetes Association (ADA) being held in San Diego, CA from June 24 to June 28.

21 Jun 2011

Amylin disappointed with U.S. District Court's ruling in BYETTA preliminary injunction

Amylin Pharmaceuticals, Inc. today issued the following statement regarding the decision of the United States District Court for the Southern District of California to deny its motion for a preliminary injunction to enjoin Eli Lilly and Company from engaging in anticompetitive activity and breaching its diabetes collaboration agreement with Amylin.

10 Jun 2011

U.S. District Court grants temporary restraining order in Amylin's litigation against Lilly

Amylin Pharmaceuticals, Inc. today announced that the United States District Court for the Southern District of California issued a temporary restraining order (TRO) against Eli Lilly and Company relating to its litigation with respect to the Amylin / Lilly diabetes collaboration agreement.

26 May 2011

Eli Lilly responds to Amylin's exenatide lawsuit

Eli Lilly and Company has provided additional perspective in response to Amylin Pharmaceuticals, Inc.'s lawsuit filed in the United States District Court for the Southern District of California.

17 May 2011

Amylin files lawsuit against Eli Lilly for improper commercialization of exenatide

Amylin Pharmaceuticals, Inc. today announced that it has filed a lawsuit against Eli Lilly and Company in the United States District Court for the Southern District of California, alleging that Lilly is engaging in anticompetitive activity and breaching its strategic alliance agreements with Amylin to maximize commercialization of exenatide.

16 May 2011

Boehringer Ingelheim, Eli Lilly receive FDA approval for linagliptin to treat type 2 diabetes

Boehringer Ingelheim and Eli Lilly and Company today announced that the U.S. Food and Drug Administration has approved linagliptin tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

3 May 2011

Boehringer Ingelheim, Eli Lilly receive FDA approval for Tradjenta to treat type 2 diabetes

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the U.S. Food and Drug Administration approved Tradjenta tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

3 May 2011

Merck's VICTRELIS phase III study results against HCV presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced results from several new data analyses from the pivotal Phase III studies evaluating the addition of its investigational oral protease inhibitor VICTRELIS to peginterferon alfa-2b and ribavirin in adult patients with chronic hepatitis C virus genotype 1 infection.

1 Apr 2011

Positive results from exenatide phase 2 study in patients with type 2 diabetes

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes.

10 Mar 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

FDA approves ONGLYZA to treat type 2 diabetes patients with renal impairment

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration has approved the inclusion of data from two clinical studies in an update to the ONGLYZA U.S. Prescribing Information for adult type 2 diabetes patients.

24 Feb 2011

Diabetes Management – a new journal addressing the management issues of a complex disease

Future Medicine Ltd has today announced the launch of Diabetes Management – a new bimonthly title presenting findings, analyses and commentaries on the battle with Type 1 and Type 2 diabetes. Diabetes Management is published by Future Medicine Ltd (UK, London) renowned for its collection of journals providing healthcare practitioners and research professionals with a unique source of objective, cutting-edge information on exciting trends emerging in light of advances in medicine, healthcare and clinical practice.

6 Feb 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

FDA approved KOMBIGLYZE XR for type 2 diabetes mellitus now available in pharmacies

Bristol-Myers Squibb Company, and AstraZeneca today announced that KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release), approved by the U.S. Food and Drug Administration (FDA) on November 5, 2010, is now available by prescription in pharmacies across the United States.

7 Jan 2011

GLUMETZA tablets are now available to wholesalers and physicians

Santarus, and Depomed, today announced that supply of GLUMETZA® 500 mg to wholesalers and retailers has resumed. GLUMETZA is a once-daily, extended release formulation of metformin and is approved for use in adults with type 2 diabetes mellitus.

5 Jan 2011