Onglyza News and Research

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New discovery in beta-cell pathway shows potential to improve effectiveness of diabetes drugs

Over the past 15 years, University of Alabama at Birmingham endocrinologist Anath Shalev, M.D., has unraveled a crucial biological pathway that malfunctions in diabetes.

8 Nov 2017

Incretin-based drugs do not increase risk of heart failure

Incretin-based drugs, a type of medication used to treat type 2 diabetes, do not increase the risk of being hospitalized for heart failure relative to commonly used combinations of oral anti-diabetic drugs, according to a new study published in the New England Journal of Medicine.

25 Mar 2016

Bristol-Myers Squibb fourth quarter 2013 revenues increase 6% to $4.4 billion

Bristol-Myers Squibb Company today reported results for the fourth quarter and full year of 2013. The fourth quarter was highlighted by the company's announcement to sell its diabetes business as part of the continued evolution of its successful BioPharma strategy to a specialty care model. The company achieved important regulatory milestones in the quarter for Eliquis in the U.S., daclatasvir/asunaprevir in Japan, daclatasvir in Europe and Farxiga in the U.S. In addition, the company provided financial guidance for 2014.

24 Jan 2014

Bristol-Myers Squibb signs agreement to sell global diabetes business

Bristol-Myers Squibb Company today announced that it has signed an agreement to sell its global diabetes business that was part of its collaboration with AstraZeneca. Under terms of the agreement, AstraZeneca will make an upfront payment of $2.7 billion to Bristol-Myers Squibb, with potential regulatory- and sales-based milestone payments of up to $1.4 billion and will make royalty payments based on net sales through 2025.

19 Dec 2013

Bristol-Myers Squibb and AstraZeneca announce top line results of Phase 4 SAVOR-TIMI-53 clinical trial of Onglyza

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced top line results of the Phase 4 SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza ® (saxagliptin).

20 Jun 2013

EU approves Forxiga for treatment of type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced that the European Commission has approved Forxiga (dapagliflozin) tablets for the treatment of type 2 diabetes in the European Union. Forxiga is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that works independently of insulin to help remove excess glucose from the body, a unique mode of action not seen in any other currently available treatments for type 2 diabetes.

15 Nov 2012

Bristol-Myers Squibb completes acquisition of Amylin

Bristol-Myers Squibb Company and AstraZeneca announced that following the successful completion of the acquisition of Amylin Pharmaceuticals by Bristol-Myers Squibb, AstraZeneca has made an initial payment of approximately $3.2 billion to Amylin Pharmaceuticals, now a wholly-owned subsidiary of Bristol-Myers Squibb.

10 Aug 2012

Bristol-Myers Squibb to acquire Amylin

Bristol-Myers Squibb Company and Amylin Pharmaceuticals, Inc. announced today that Bristol-Myers Squibb will acquire Amylin for $31.00 per share in cash, pursuant to a cash tender offer and second step merger, or an aggregate purchase price of approximately $5.3 billion.

2 Jul 2012

European Commission approves ONGLYZA as combination therapy with insulin for type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced that the European Commission has approved ONGLYZA (saxagliptin) for use as a combination therapy with insulin (with or without metformin) to improve blood sugar (glycaemic) control in adult patients with type 2 diabetes.

28 Nov 2011

ONGLYZA used with insulin maintains improvement in glucose control in adults with type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced results from an investigational Phase 3b clinical study in which the addition of ONGLYZA (saxagliptin) 5 mg to ongoing insulin therapy (with or without metformin) maintained reductions of blood sugar levels (glycosylated hemoglobin levels, or HbA1c) in adult patients with type 2 diabetes compared to the addition of placebo (with or without metformin) from 24 to 52 weeks.

16 Sep 2011

Bristol-Myers Squibb first quarter net sales increase 5% to $3.3 billion

Bristol-Myers Squibb Company today announced first quarter results that included strong sales and earnings growth, and several key R&D milestones—most notably U.S. regulatory approval for YERVOY. The company also confirmed guidance for the year.

30 Apr 2011

European Commission approves BMY's ONGLYZA to treat type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced that the European Commission has approved a label update for ONGLYZA in the treatment of adults with type 2 diabetes who have moderate or severe renal impairment. The approved dosage for the patient group is a new once-daily 2.5 mg dose.

4 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

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

Bristol-Myers Squibb 2010 third quarter U.S. net sales increases 4% to $3.1 billion

Bristol-Myers Squibb Company today reported results for the third quarter of 2010. Highlights in the quarter included: the presentation of new data on investigational compounds in the diabetes and cardiovascular disease franchises at major medical meetings; the completion of important regulatory milestones in the oncology, diabetes and immunoscience franchises; the acquisition of ZymoGenetics; and double-digit EPS growth. The company also confirmed guidance for 2010.

26 Oct 2010

Bristol-Myers Squibb second-quarter net sales increase 2% to $4.8 billion

Bristol-Myers Squibb Company today reported results for the second quarter of 2010 which featured data on key marketed and investigational compounds in its oncology, diabetes and cardiovascular franchises, and growth in sales and EPS. The company also confirmed guidance for 2010 and minimum guidance for non-GAAP EPS in 2013.

22 Jul 2010

Study: ONGLYZA and metformin improve HbA1c levels for adult patients with type 2 diabetes at 76-weeks

Bristol-Myers Squibb Company and AstraZeneca today announced results up to 76-weeks from a Phase 3 study of ONGLYZA(TM) (saxagliptin) as initial combination therapy with metformin, which produced long-term glycemic improvement (as measured by glycosylated hemoglobin level (HbA1c)) in treatment-naive adults with type 2 diabetes mellitus inadequately controlled on diet and exercise compared to treatment with an investigational 10 mg dose of saxagliptin or metformin alone.

2 Jul 2010

Bristol-Myers Squibb reports 11% increase in first-quarter 2010 revenue

Bristol-Myers Squibb Company today reported strong sales and earnings growth for the first quarter of 2010.

30 Apr 2010

ONGLYZA-metformin combination: FDA accepts NDA for review

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.

17 Mar 2010

Bristol-Myers Squibb, AstraZeneca commence SAVOR-TIMI 53 trial of ONGLYZA for type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced the commencement of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” trial, a multicenter, randomized, double-blind, placebo-controlled Phase 4 study, to evaluate treatment with ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 inhibitor, in adult type 2 diabetes patients with cardiovascular risk factors.

10 Mar 2010