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ACE, ARB combination therapy may increase risk of kidney failure, death

Elderly patients prescribed combination angiotensin converting enzyme inhibitors and angiotensin receptor blockers had a higher risk of kidney failure and death, according to a study published in CMAJ.

22 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

Combination therapy may reduce albuminuria in patients with type 2 diabetes: Study

Results from a Phase 2, 8-week dose-ranging study using low doses of atrasentan in patients with diabetic kidney disease were published this week in the Journal of the American Society of Nephrology. The published study results suggest that atrasentan, used in conjunction with renin-angiotensin system inhibitors, may reduce albuminuria (presence of protein in urine) for patients with type 2 diabetes.

5 Mar 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

Takeda receives FDA approval for EDARBI to treat hypertension in adults

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration approved EDARBI for the treatment of hypertension, or high blood pressure, in adults.

27 Feb 2011

Study finds link between fasting serum glucose levels and in-hospital mortality in elderly non-diabetic patients

A two-country hospital study of 808 elderly patients found a strong association between high, undiagnosed blood glucose in non-diabetic patients and increased hospital death rates, according to the March issue of IJCP, the International Journal of Clinical Practice.

24 Feb 2011

Takeda submits NDA to FDA for fixed-dose combination of azilsartan medoxomil plus CLD to treat hypertension

Takeda Pharmaceutical Company Limited announced today that Takeda Global Research & Development Center, Inc. U.S., submitted a New Drug Application to the U.S. Food and Drug Administration for an investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone for the treatment of hypertension, or high blood pressure.

24 Feb 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

Amgen announces publication of XGEVA Phase 3 study results against solid tumors in Journal of Clinical Oncology

Amgen today announced the publication of results from a pivotal Phase 3 study of 1,776 advanced cancer patients with different types of solid tumors or multiple myeloma, which compared XGEVA to Zometa in preventing skeletal-related events.

23 Feb 2011

State court jury rules in favor of Merck in FOSAMAX trial

Merck & Co., Inc. today said a state court jury in New Jersey found in its favor in the Rosenberg v. Merck case, rejecting the claims of a woman who blamed her dental and jaw related problems on her FOSAMAX use.

15 Feb 2011

Scientists create 'reporter mouse' to close gap between kidney injury and diagnosis

The current check for kidney disease is a simple blood test for serum creatinine, but it can take longer than two days for this metabolite to accumulate to levels that are significant enough to indicate kidney damage - and by then it may be too late to intervene.

1 Feb 2011

Triad alcohol prep pads with ARIXTRA Starter Kits not to be used

GlaxoSmithKline (GSK) has become aware of a United States market recall of all lots of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names. The Triad Group recall has been initiated due to concerns about potential microbial contamination of the alcohol products with Bacillus cereus that could potentially lead to life-threatening infections.

25 Jan 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

FDA approves Novartis' Amturnide for treatment of high blood pressure

Today Novartis announced that the US Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

23 Dec 2010

Study suggests blood test may detect persons with CKD

An infrequently used blood test can effectively identify individuals at increased risk of developing complications associated with chronic kidney disease (CKD), according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology (JASN).

17 Dec 2010

BELLUS Health, Celtic Therapeutics initiate KIACTA global confirmatory phase III clinical study for AA amyloidosis

BELLUS Health Inc. and Celtic Therapeutics announced today that a global confirmatory phase III clinical study was initiated on December 14, 2010 for KIACTA™ (eprodisate). KIACTA™ is a drug candidate being developed for the treatment of AA amyloidosis, a life-threatening orphan disease that occurs in patients with long-lasting inflammatory conditions, most commonly due to rheumatoid arthritis. The study is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients with AA amyloidosis.

16 Dec 2010

Ikaria initiates enrollment in LUCASSIN Phase III trial for HRS Type 1

Ikaria, Inc. announced that it has enrolled the first patients in its pivotal Phase III trial for LUCASSIN® (terlipressin). The multi-center, randomized, placebo-controlled, double-blind trial is known as the REVERSE Trial.

30 Nov 2010

FTC/TDF tablet reduces HIV infection among high-risk individuals: iPrEx study

In a finding with the potential to fundamentally change strategies to slow the global HIV epidemic, a new study called iPrEx shows that individuals at high risk for HIV infection who took a single daily tablet containing two widely used HIV medications, emtricitabine and tenofovir (FTC/TDF), experienced an average of 43.8% fewer HIV infections than those who received a placebo pill. New England Journal of Medicine, is the first evidence that this new HIV prevention method, called pre-exposure prophylaxis or PrEP, reduces HIV infection risk in people.

24 Nov 2010

iPrEx study: PrEP reduces HIV infection risk among gay, bisexual men

A daily dose of an oral antiretroviral drug, currently approved to treat HIV infection, reduced the risk of acquiring HIV infection by 43.8 percent among men who have sex with men.

24 Nov 2010

Creatinine News and Research

ACE, ARB combination therapy may increase risk of kidney failure, death

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

Combination therapy may reduce albuminuria in patients with type 2 diabetes: Study

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

Takeda receives FDA approval for EDARBI to treat hypertension in adults

Study finds link between fasting serum glucose levels and in-hospital mortality in elderly non-diabetic patients

Takeda submits NDA to FDA for fixed-dose combination of azilsartan medoxomil plus CLD to treat hypertension

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

Amgen announces publication of XGEVA Phase 3 study results against solid tumors in Journal of Clinical Oncology

State court jury rules in favor of Merck in FOSAMAX trial

Scientists create 'reporter mouse' to close gap between kidney injury and diagnosis

Triad alcohol prep pads with ARIXTRA Starter Kits not to be used

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

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

FDA approves Novartis' Amturnide for treatment of high blood pressure

Study suggests blood test may detect persons with CKD

BELLUS Health, Celtic Therapeutics initiate KIACTA global confirmatory phase III clinical study for AA amyloidosis

Ikaria initiates enrollment in LUCASSIN Phase III trial for HRS Type 1

FTC/TDF tablet reduces HIV infection among high-risk individuals: iPrEx study

iPrEx study: PrEP reduces HIV infection risk among gay, bisexual men

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