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FDA approves sNDA for pediatric autism drug ABILIFY

20. November 2009 23:40
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. [More]

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

3. November 2009 03:02
Schering-Plough Corporation today 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. [More]

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

2. November 2009 04:03
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. [More]

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

2. November 2009 03:59
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. [More]

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Gilead Sciences to present Viread Phase III clinical trial data

2. November 2009 03:24
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. [More]

Schering-Plough receives FDA complete response letter regarding PEGINTRON

31. October 2009 03:09
Schering-Plough Corp. announced today 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. [More]

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

24. October 2009 07:16
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. [More]

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

22. October 2009 05:02
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. [More]

New results from ADVANCE provide important insights to reduce diabetes complications

21. October 2009 06:39
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. [More]

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

21. October 2009 06:00
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. [More]

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

20. October 2009 01:34
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. [More]

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

19. October 2009 09:47
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. [More]

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

19. October 2009 08:38
Schering-Plough today 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. [More]

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

19. October 2009 08:23
Ardea Biosciences, Inc. today 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. [More]

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

19. October 2009 05:15
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. [More]
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