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Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

Eisai Inc. announced today preliminary results from a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection versus either a low-dose chemotherapy agent or supportive care in elderly patients with acute myeloid leukemia (AML), a life-threatening cancer of the blood that generally occurs in older adults.

1 Jul 2010

SuperGen encouraged by Eisai's intent to file Dacogen sNDA for new indication

SuperGen, Inc., a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that Eisai Inc. today released information regarding a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection in elderly patients with acute myeloid leukemia (AML). The comparator in this trial was low-dose cytarabine, a chemotherapy agent, or supportive care.

30 Jun 2010

Merck challenges New York jury decision in federal FOSAMAX retrial

Merck & Co., Inc. today said it is challenging the decision returned by a New York jury in the retrial of a federal FOSAMAX case, Boles v. Merck. This case was the Plaintiffs' Steering Committee's top choice to take to trial and involved a Florida woman who blamed her dental and jaw problems on FOSAMAX. The first case to reach a verdict, Maley v. Merck, resulted in a defense verdict for Merck on May 5, 2010.

28 Jun 2010

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

New data were presented at the American Diabetes Association 70th Annual Scientific Sessions from a study comparing JANUMET (sitagliptin/metformin) to pioglitazone. In this study, JANUMET resulted in significantly greater blood sugar reductions in patients with type 2 diabetes compared with pioglitazone.

28 Jun 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

SYMPLICITY HTN-1 study: RDN treatment significantly reduces blood pressure

Long-term data presented today from Ardian's SYMPLICITY HTN-1 study demonstrate that the significant reductions in blood pressure achieved using Renal Denervation treatment are sustained through 24 months. The data were presented at the late breaking trials session of the European Society of Hypertension Annual Scientific meeting in Oslo, Norway.

22 Jun 2010

Additional positive data from Ardea Biosciences' RDEA594 Phase 2 program presented at EULAR

Ardea Biosciences, Inc. announced that additional positive data from its Phase 2 program for RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, are being presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in Rome, Italy. RDEA594, a first-in-class selective inhibitor of the URAT1 transporter, treats the underlying cause of gout by increasing the excretion of uric acid in order to bring the body's levels of uric acid into a normal range.

18 Jun 2010

Alexion's Soliris may benefit patients with thrombotic microangiopathy from uncontrolled complement activation

Researchers reported today that Soliris® (eculizumab), a first-in-class terminal complement inhibitor developed by Alexion Pharmaceuticals, Inc., may provide clinical benefits to patients with thrombotic microangiopathy (TMA) resulting from uncontrolled complement activation. TMA, the formation of blood clots in capillaries and small arteries, can lead to life-threatening damage in multiple organs including kidney failure, thrombocytopenia (abnormally low platelet count) and anemia.

15 Jun 2010

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

Abraxis BioScience, Inc. presented trial design information from its ongoing phase 3 registration trial of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), in melanoma, an aggressive form of skin cancer that affects more than 68,000 people in the U.S. each year.

11 Jun 2010

Researchers compare effectiveness of IB and AMP in high-risk patients

Major amputation is often selected over infrainguinal bypass in patients with severe systemic comorbidities because of a presumed decrease in risk of perioperative morbidity and mortality. To investigate this presumption, researchers from the Division of Vascular and Endovascular Surgery at the Brigham and Women's Hospital in Boston undertook a risk-adjusted comparison of early postoperative morbidity and mortality of high-risk patients undergoing infrainguinal bypass and major amputation.

9 Jun 2010

Multiple presentations on nab-driven chemotherapy at 46th ASCO

Abraxis BioScience, Inc. presented abstracts describing 10 trials of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), for the treatment of breast cancer at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

9 Jun 2010

Low-income African-Americans have higher risk of CKD: Research

African Americans with incomes below the poverty line have a significantly higher risk of chronic kidney disease than higher-income African-Americans or whites of any socioeconomic status, research led by scientists at Johns Hopkins and the National Institute on Aging shows. Conducted in a racially and socioeconomically diverse sample of participants from the city of Baltimore, Md., the study could help researchers eventually develop strategies to prevent CKD in vulnerable populations.

9 Jun 2010

Merck's MK-4305 improves overall sleep efficiency in primary insomnia patients

Clinical results from a Phase IIb study showed that MK-4305, Merck's investigational dual orexin receptor antagonist, was significantly more effective than placebo (p<0.005) in improving overall sleep efficiency at night one and at the end of week four in patients with primary insomnia. MK-4305 was generally well-tolerated in the study. Orexins are neuropeptides (chemical messengers) that are released by specialized neurons in the hypothalamus region of the brain and are believed to be an important regulator of the brain's sleep-wake process.

9 Jun 2010

Findings from Abraxis BioScience's phase 3 ABRAXANE trial in patients with NSCLC presented at ASCO

Abraxis BioScience, Inc. announced today that findings from their phase 3 randomized trial of nanoparticle albumin bound driven chemotherapy, nab-paclitaxel (ABRAXANE for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension) plus carboplatin, showed a statistically significant 31 percent improvement in overall response rate when compared with Taxol (paclitaxel) injection plus carboplatin in the first-line treatment of patients with non-small cell lung cancer.

8 Jun 2010

Novartis' Afinitor decreases size of SEGAs associated with tuberous sclerosis

Novartis Pharmaceuticals Corporation announced today that results from a Phase II study show Afinitor® (everolimus) tablets is the first medication in a clinical trial to decrease the size of subependymal giant cell astrocytomas (SEGAs), benign brain tumors associated with tuberous sclerosis (TS). In this study of 28 patients presented today at the 46th American Society of Clinical Oncology (ASCO) annual meeting in Chicago, 75% of patients experienced a reduction of 30% or greater in the size of their brain tumors from baseline to six months (p<0.001).

7 Jun 2010

Promising results of ABRAXANE for bladder cancer support efficacy of nab-driven chemotherapy

Abraxis BioScience, Inc. announced today that findings from a phase 1 randomized trial demonstrated that the nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension) is well-tolerated and active in the second-line treatment of high-grade, non-muscle-invasive bladder cancer that has been refractory to standard intra-bladder infusion (intravesical) therapy.

4 Jun 2010

Phase III study of Afinitor tablets in patients with advanced pancreatic NET meets primary endpoint

Novartis Pharmaceuticals Corporation announced today that a Phase III study of Afinitor (everolimus) tablets plus best supportive care met its primary endpoint, showing the drug significantly extended progression-free survival, or time without tumor growth, in patients with advanced pancreatic neuroendocrine tumors.

3 Jun 2010

Data evaluating use of nab-paclitaxel for treatment of pancreatic cancer to be presented at ASCO 2010

Abraxis BioScience, Inc., a fully integrated biotechnology company, previously announced it will be presenting more than 30 studies, including new clinical data evaluating the use of nanoparticle albumin bound driven chemotherapy, nab-paclitaxel (ABRAXANE for Injectable suspension; paclitaxel protein albumin-bound particles for injectable suspension) for the treatment of pancreatic cancer at the 46th Annual Meeting of the American Society of Clinical Oncology in Chicago.

21 May 2010

New data highlighting Pfizer's approach to cancer drug development to be presented at ASCO meeting

Pfizer Oncology will present new data highlighting the company's focused approach to cancer drug development through the identification and validation of molecular targets. These results will be presented at the 46th Annual American Society of Clinical Oncology meeting in Chicago from June 4-8.

21 May 2010

eGFR as valuable as Ccr as an indicator of preoperative renal function in gastric cancer patients: Study

The creatinine clearance (Ccr) test has been used as a gold standard for evaluation of preoperative renal function in patients with gastric cancer. However, it is known that Ccr is not strictly equivalent to glomerular filtration rate (GFR). It has been accepted that estimated GFR (eGFR) is equal to measured GFR in chronic kidney disease. However, there have been no studies regarding the reliability of eGFR as a preoperative renal function test in gastric cancer patients.

21 May 2010

Creatinine News and Research

Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

SuperGen encouraged by Eisai's intent to file Dacogen sNDA for new indication

Merck challenges New York jury decision in federal FOSAMAX retrial

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

SYMPLICITY HTN-1 study: RDN treatment significantly reduces blood pressure

Additional positive data from Ardea Biosciences' RDEA594 Phase 2 program presented at EULAR

Alexion's Soliris may benefit patients with thrombotic microangiopathy from uncontrolled complement activation

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

Researchers compare effectiveness of IB and AMP in high-risk patients

Multiple presentations on nab-driven chemotherapy at 46th ASCO

Low-income African-Americans have higher risk of CKD: Research

Merck's MK-4305 improves overall sleep efficiency in primary insomnia patients

Findings from Abraxis BioScience's phase 3 ABRAXANE trial in patients with NSCLC presented at ASCO

Novartis' Afinitor decreases size of SEGAs associated with tuberous sclerosis

Promising results of ABRAXANE for bladder cancer support efficacy of nab-driven chemotherapy

Phase III study of Afinitor tablets in patients with advanced pancreatic NET meets primary endpoint

Data evaluating use of nab-paclitaxel for treatment of pancreatic cancer to be presented at ASCO 2010

New data highlighting Pfizer's approach to cancer drug development to be presented at ASCO meeting

eGFR as valuable as Ccr as an indicator of preoperative renal function in gastric cancer patients: Study

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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