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

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.

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

Safety profiles of JANUVIA and JANUMET drugs established through clinical development program

Merck has thoroughly reviewed the safety data for sitagliptin, and sitagliptin was not associated with an increase in the incidence of pancreatitis in preclinical studies or in clinical trials of up to two years in duration with more than 6,000 patients.

28 Sep 2009

European CHMP recommends Merck's JANUVIA and JANUMET as add-on to insulin

Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for JANUVIA® tablets and JANUMET® tablets recommending their use as add-on to insulin for the treatment of type 2 diabetes.

26 Sep 2009

iCo Therapeutics, CPDD sign collaboration development agreement

iCo Therapeutics Inc. (TSX-V: ICO) is pleased to announce that the company has signed a collaboration development agreement with The Consortium for Parasitic Drug Development (CPDD) for the research and development of iCo's oral drug delivery technology for the treatment of neglected diseases such as leishmaniasis and trypanosomiasis. Initial funding of USD $182,930 will be provided for formulation optimization for tropical conditions.

25 Sep 2009

Pros and cons of the estimated Glomerular Filtration Rate

As many as 26 million Americans live with chronic kidney disease (CKD) and according to the National Institutes of Health (NIH), at least 10.4 million (or 40%) don't even know they have it. Enter the estimated Glomerular Filtration Rate (eGFR), which has become the preferred method for identifying people with CKD.

23 Sep 2009

Results of IES presented at ECCO

Pfizer Inc today announced new, longer-term data from the Intergroup Exemestane Study (IES) showing that women who switched to AROMASIN® (exemestane tablets) after taking tamoxifen for two to three years experienced a significant reduction (18%) in the risk of disease-free survival (DFS) events. In addition, IES showed that AROMASIN prolonged overall survival (OS) in the ER+/unknown population with a 14% reduction in the risk of dying. These results demonstrate that the benefits of treatment are maintained in long term follow-up. These results were presented at the joint ECCO 15/ESMO 34 meeting in Berlin, Germany.

23 Sep 2009

Pfizer Oncology to present early-stage research of investigational agents for cancer treatment

Pfizer Oncology will present data from across its portfolio, including results from long-term follow-up of Aromasin® (exemestane tablets) in a study of early breast cancer, updated study results from a Phase 3 study of Sutent® (sunitinib malate) in pancreatic neuroendocrine tumors (NET), and early-stage research of investigational agents PF-02341066 and figitumumab (CP-751,871) in patients with non-small cell lung cancer (NSCLC).

19 Sep 2009

Positive results from Merck's Phase IIB clinical study of odanacatib for treating osteoporosis

New data from a Phase IIB clinical study of odanacatib, Merck & Co., Inc.'s oral, once-weekly investigational treatment for osteoporosis, showed that when stopping treatment after two years, the increases in lower back (lumbar spine) bone mineral density (BMD) were reversed over the next year, while BMD at the hip (femoral neck) remained above levels observed at the start of the study.

15 Sep 2009

End stage renal disease can be delayed by early identification of CKD

Early identification of individuals with chronic kidney disease (CKD) can delay the onset of end stage renal disease (ESRD) and the need for chronic dialysis treatments. The incidence of CKD continues to grow, and early identification and intervention are critical to manage this costly disease.

11 Sep 2009

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009

Patient enrollment completed in Phase 2b clinical trial for Pyridorin

NephroGenex, Inc., a privately held drug development company focusing on kidney disease, today announced the completion of patient enrollment in its Phase 2b clinical trial (PYR-210) studying the safety and efficacy of its lead drug candidate Pyridorin (pyridoxamine dihydrochloride) in type 2 diabetic patients with overt diabetic nephropathy. Three hundred and seventeen (317) patients have been randomized.

10 Sep 2009

The Kyoto Heart study shows positive effect of valsartan on cardiovascular outcome

The KYOTO HEART Study, which took place in Japan between January 2004 and January 2009, shows that the addition of valsartan to conventional antihypertensive treatment to improve blood pressure control is associated with an improved cardiovascular outcome in Japanese hypertensive patients at high risk of CVD events.

2 Sep 2009

PROTECT clinical study aimed at the assessment of rolofylline effects

Despite the promising findings of the PROTECT Pilot study, the larger PROTECT trial found no difference with rolofylline versus placebo with respect of the primary and main secondary end-points of the study. Although more rolofylline patients than placebo patients experienced moderate or marked dyspnea improvement at 24 and 48 hours from randomization, this was counterbalanced by a lack of effect on persistent renal impairment. Lastly, the risk of important neurological events was increased in patients on rolofylline.

2 Sep 2009

Study reveals that valsartan prevents cardiovascular events in high-risk hypertensive Japanese patients

2 Sep 2009

Two human biomarker assays that play a key role in the early detection of kidney damage provide assistance in drug development

Geneuity Clinical Research Services announces the recent validation and use in clinical trials of two human biomarker assays that play a key role in the early detection of kidney damage.

29 Aug 2009

'Urine NGAL' gives clues to kidney injury in ICU patients and HIV-related kidney disease

Acute kidney injury (AKI) is a frequent complication in patients in intensive care. A new laboratory test called urine neutrophil gelatinase associated lipocalin (NGAL) helps predict if patients will develop acute kidney injury, reports an upcoming study in the Journal of the American Society of Nephrology (JASN).

26 Jul 2009

Creatinine News and Research

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

Safety profiles of JANUVIA and JANUMET drugs established through clinical development program

European CHMP recommends Merck's JANUVIA and JANUMET as add-on to insulin

iCo Therapeutics, CPDD sign collaboration development agreement

Pros and cons of the estimated Glomerular Filtration Rate

Results of IES presented at ECCO

Pfizer Oncology to present early-stage research of investigational agents for cancer treatment

Positive results from Merck's Phase IIB clinical study of odanacatib for treating osteoporosis

End stage renal disease can be delayed by early identification of CKD

Merck update on the status of telcagepant clinical development programs

Patient enrollment completed in Phase 2b clinical trial for Pyridorin

The Kyoto Heart study shows positive effect of valsartan on cardiovascular outcome

PROTECT clinical study aimed at the assessment of rolofylline effects

Study reveals that valsartan prevents cardiovascular events in high-risk hypertensive Japanese patients

Two human biomarker assays that play a key role in the early detection of kidney damage provide assistance in drug development

'Urine NGAL' gives clues to kidney injury in ICU patients and HIV-related kidney disease

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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