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U.S. Court rules in Merck's favor in Flemings case involving FOSAMAX

Merck said today that U.S. District Court Judge John F. Keenan granted summary judgment in Merck's favor in Flemings v. Merck. Flemings is the second of three cases involving FOSAMAX (alendronate sodium) designated by the federal MDL court as a bellwether trial case.

24 Nov 2009

FDA approves sNDA for pediatric autism drug ABILIFY

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

20 Nov 2009

Interim data from Schering-Plough's narlaprevir Phase IIa study

Schering-Plough Corporation reported that interim results from an ongoing Phase IIa study of narlaprevir (SCH 900518), its investigational, once-daily protease inhibitor, demonstrated potent antiviral activity in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1.

3 Nov 2009

Interim data from Bristol-Myers Squibb's BARACLUDE study for chronic hepatitis B patients

Bristol-Myers Squibb today announced 48-week data from an ongoing study (ETV-048) of chronic hepatitis B patients with decompensated cirrhosis, in which BARACLUDE demonstrated greater viral suppression compared to adefovir. The new BARACLUDE data were presented today at the 60th Annual Meeting of the American Association for the Study of Liver Diseases.

2 Nov 2009

Women at particular risk of their primary care physicians delaying diagnosis of CKD: Study

Woman are at particular risk of their primary care physicians delaying diagnosis of chronic kidney disease (CKD), according to a paper being presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition in San Diego, California. The findings suggest that educating practitioners about CKD could increase the timely diagnosis of CKD, thereby leading to improvements in care to patients and savings in Medicare dollars.

2 Nov 2009

Gilead Sciences to present Viread Phase III clinical trial data

Gilead Sciences, Inc. today announced the presentation of three-year (144-week) open label data from two pivotal Phase III clinical trials, Studies 102 and 103, evaluating the safety and efficacy of once-daily Viread® (tenofovir disoproxil fumarate) among adult patients with chronic hepatitis B virus (HBV) infection.

2 Nov 2009

Schering-Plough receives FDA complete response letter regarding PEGINTRON

Schering-Plough Corp. announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.

31 Oct 2009

DaVita to demonstrate clinical outcomes, patient care and nutrition through 43 abstracts

DaVita Inc., a leading provider of kidney care services for those diagnosed with chronic kidney disease (CKD), in conjunction with DaVita Clinical Research®, today announced that company representatives will deliver 43 abstracts—40 posters and three oral presentations—at this year’s American Society of Nephrology’s (ASN) Renal Week to be held in San Diego, Calif., from Oct. 27 – Nov. 1, 2009.

24 Oct 2009

Study explores aldosterone antagonist usage among US patients hospitalised with heart failure

A study published today in JAMA (October 21) by Nancy M. Albert and colleagues, exploring aldosterone antagonist usage among US patients hospitalised with heart failure, found that only one-third of patients meeting current US Clinical Practice Guidelines criteria were actually being treated.

22 Oct 2009

New results from ADVANCE provide important insights to reduce diabetes complications

New results from ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation), the largest clinical trial ever performed in patients with type 2 diabetes worldwide, provide important insights into the therapeutic strategy to adopt for efficient and safe blood glucose control aimed at the reduction of severe diabetes complications.

21 Oct 2009

Study of aldosterone antagonist usage among patients hospitalised with heart failure published

21 Oct 2009

Data on ULORIC treatment for gout flares presented at the 73rd American College of Rheumatology meeting

Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to <6.0 mg/dL and the frequency of flares with ULORIC- (febuxostat) treatment.

20 Oct 2009

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for its angiotensin II receptor blocker (ARB) Micardis® (telmisartan) Tablets 80 mg for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take angiotensin-converting enzyme (ACE) inhibitors.(1) MICARDIS is the most studied ARB in this high-risk patient population and has been commercially available to treat hypertension (high blood pressure) since its approval in 1998.

19 Oct 2009

Schering-Plough to present data on boceprevir at the AASLD 2009 Annual Meeting

Schering-Plough announced that data on boceprevir, an investigational hepatitis C virus (HCV) protease inhibitor, will be reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3.

19 Oct 2009

Ardea Biosciences reports results of RDEA594 Phase 2a study for hyperuricemia and gout

Ardea Biosciences, Inc. announced additional positive results from the completed first cohort of an ongoing Phase 2a, proof-of-concept study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout.

19 Oct 2009

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

19 Oct 2009

FDA grants marketing approval for Elitek

Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Elitek (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

19 Oct 2009

H1N1 illness in young Mexican patients associated with severe acute respiratory distress syndrome

Critical illness from 2009 influenza A(H1N1) in Mexico occurred among young patients, was associated with severe acute respiratory distress syndrome and shock, and had a fatality rate of about 40 percent, according to a study to appear in the November 4 issue of JAMA.

12 Oct 2009

Schering-Plough receives FDA recommendation approval for PEGINTRON

Schering-Plough Corp. announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for PEGINTRON® (pegylated interferon alfa-2b) in the adjuvant treatment of patients with Stage III malignant melanoma.

6 Oct 2009

Dapagliflozin with metformin reduces glycosylated hemoglobin level and body weight

Results from a 24-week phase 3 clinical study demonstrated that the investigational drug dapagliflozin, added to metformin, demonstrated significant mean reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c) and in the secondary endpoint, fasting plasma glucose (FPG) in patients with type 2 diabetes inadequately controlled with metformin alone, as compared to placebo plus metformin.

3 Oct 2009

Creatinine News and Research

U.S. Court rules in Merck's favor in Flemings case involving FOSAMAX

FDA approves sNDA for pediatric autism drug ABILIFY

Interim data from Schering-Plough's narlaprevir Phase IIa study

Interim data from Bristol-Myers Squibb's BARACLUDE study for chronic hepatitis B patients

Women at particular risk of their primary care physicians delaying diagnosis of CKD: Study

Gilead Sciences to present Viread Phase III clinical trial data

Schering-Plough receives FDA complete response letter regarding PEGINTRON

DaVita to demonstrate clinical outcomes, patient care and nutrition through 43 abstracts

Study explores aldosterone antagonist usage among US patients hospitalised with heart failure

New results from ADVANCE provide important insights to reduce diabetes complications

Study of aldosterone antagonist usage among patients hospitalised with heart failure published

Data on ULORIC treatment for gout flares presented at the 73rd American College of Rheumatology meeting

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Schering-Plough to present data on boceprevir at the AASLD 2009 Annual Meeting

Ardea Biosciences reports results of RDEA594 Phase 2a study for hyperuricemia and gout

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

FDA grants marketing approval for Elitek

H1N1 illness in young Mexican patients associated with severe acute respiratory distress syndrome

Schering-Plough receives FDA recommendation approval for PEGINTRON

Dapagliflozin with metformin reduces glycosylated hemoglobin level and body weight

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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