Renal Failure News and Research

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Renal failure or kidney failure is where the kidneys fail to function adequately. Renal failure is divided in acute and chronic forms; either form may be due to a large number of other medical problems.

FDA grants orphan drug designation to NephRx's lead product NX001

NephRx Corporation today announced that the U.S. Food and Drug Administration has granted orphan drug designation to its lead product NX001 for the prevention of delayed graft function in renal transplant recipients. NX001 is a kidney growth factor peptide that has demonstrated good safety and promising efficacy in two animal models of acute renal failure.

18 Aug 2010

Tengion announces clinical, corporate and second-quarter financial updates

Tengion Inc. today provided a corporate and product development update and reported its financial results for the quarter ended June 30, 2010.

12 Aug 2010

Amgen reports top-line results from Vectibix Phase 3 trial for head and neck cancer

Amgen today announced top-line results from a randomized Phase 3 trial evaluating Vectibix as a first-line treatment in patients with recurrent and/or metastatic squamous cell head and neck cancer. The data showed the addition of Vectibix to platinum-based chemotherapy did not result in a statistically significant improvement in overall survival, the primary endpoint, compared to chemotherapy alone.

12 Aug 2010

AACN endorses new clinical practice guidelines developed by Renal Physicians Association

The American Association of Critical-Care Nurses (AACN) recently endorsed the clinical practice guideline, "Shared Decision Making in the Appropriate Initiation of and Withdrawal from Dialysis," developed by Renal Physicians Association (RPA), Rockville, Md.

11 Aug 2010

Hemodialysis with AVF depends on patient’s health insurance: Study

Kidney disease patients insured by some federally sponsored national health care organizations are more likely to undergo an important predialysis procedure than patients with other types of insurance, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology (JASN). The results may provide insights into ways to improve kidney-related care for patients before they go on dialysis.

10 Aug 2010

Affymax, Takeda announce preliminary strategy for Hematide to treat anemia in chronic renal failure patients

Affymax, Inc. and Takeda Pharmaceutical Company Limited, today announced that the companies have decided on a preliminary strategic path forward for the investigational drug, Hematide™/peginesatide, for the treatment of anemia in chronic renal failure patients in the United States.

5 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

Affymax reports second-quarter net income of $17.3M against loss last year

Affymax, Inc. today reported financial results for the second quarter ended June 30, 2010. Net income for the second quarter of 2010 was $17.3 million compared to a net loss of $22.1 million for the second quarter of 2009. The company received milestone payments of $30.0 million from Takeda Pharmaceutical Company Limited for database lock of the Hematide/peginesatide Phase 3 clinical trials.

5 Aug 2010

Safeguard Scientifics second-quarter aggregate revenue of partner companies increase 47% to $91.6 million

Safeguard Scientifics, Inc., a holding company that builds value in growth-stage life sciences and technology companies, today announced that aggregate revenue of its partner companies for the three months ended June 30, 2010 was $91.6 million, up 47% from $62.3 million for the same partner companies in the same period of 2009. For the six months ended June 30, 2010, the aggregate partner company revenue was $176.9 million, up 45% from $121.8 million for the same partner companies for the same period of 2009.

29 Jul 2010

Study reveals high rate of atrial fibrillation in patients with early stages of CKD

Millions of Americans in the early stages of chronic kidney disease (CKD) are at an increased risk of having atrial fibrillation (AF) - a major risk factor for stroke - according to new research by investigators at Wake Forest University Baptist Medical Center.

29 Jul 2010

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

New study reveals potential role of TGF-β1 in kidney disease

Fibrosis in the kidney is one of the key causes of progressive renal failure. High levels of the inflammatory molecule TGF-β1 in the kidney tubules due to tissue damage can cause fibrosis as well as nephron degeneration, resulting in loss of kidney function. To clarify the mechanisms regulating TGF-β1-mediated renal fibrosis, Koesters et al expressed high levels of TGF-β1 in renal tubules of mice. Nephron degeneration in this system was mediated by decomposition of the tubular cells. These data suggest that TGF-β1 may play a novel role in cell death of renal cells, thus contributing to renal fibrosis.

28 Jul 2010

Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced the start of a U.S. Phase I clinical trial of its biosimilar erythropoietin (EPO) in patients with renal (kidney) dysfunction who have anemia, an important step on the road toward introducing a biosimilar product in the United States. Erythropoietin is a treatment for anemia associated with chronic renal failure and chemotherapy.

26 Jul 2010

Affymax completes sale of all auction rate securities held by UBS

Affymax, Inc. today announced the completion of the sale at par value of all auction rate securities held by UBS AG and its affiliates in a transaction which generated net proceeds of $5.0 million to Affymax, after payment of $5.4 million from the proceeds to retire a loan due to UBS. From April 1, 2010 through June 30, 2010, $3.7 million of the UBS ARS were settled at par value resulting in a corresponding reduction in the balance of UBS ARS and related loan since the first quarter 2010. The company now has no debt liability on its balance sheet.

20 Jul 2010

New research shows Alzheimer's disease may increase risk of other potentially disabling health conditions

Having Alzheimer's disease may increase the risk of getting other potentially disabling health conditions, including seizures and anemia, according to new research presented today at the Alzheimer's Association International Conference on Alzheimer's Disease 2010 in Honolulu, HI.

14 Jul 2010

FDA grants Angion Biomedica's BB3 therapeutic Fast Track and Orphan Drug product designations

Angion Biomedica Corp., a biopharmaceutical company dedicated to the discovery and development of novel therapeutics that enhance quality of life, eradicate disease and save lives by modulating the body's protective, reparative and regenerative systems, announced today that its lead therapeutic BB3 was accepted into the Fast Track program of the U.S. Food and Drug Administration (FDA) and has also been designated an Orphan Drug product by FDA.

7 Jul 2010

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Novartis Pharmaceuticals Corporation announced today that results of a Phase III study show Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival, or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET). The study, RADIANT-3, was presented at the 12th World Congress on Gastrointestinal Cancer and is part of the largest clinical trial program in patients with advanced NET.

1 Jul 2010

Study highlights importance of individualized, patient-centered therapies

In an analysis from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, one of the largest studies of its kind to determine whether intensive blood glucose (sugar) control worked better than standard blood sugar control among diabetics, results show that the benefits of intensive therapy need to be balanced against the increase in total and cardiovascular disease-related death, increased weight gain, and high risk for severe low blood sugar.

30 Jun 2010

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Raptor Pharmaceutical Corp. announced that it has enrolled the first patient in a pivotal Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

28 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

Renal Failure News and Research

Further Reading

FDA grants orphan drug designation to NephRx's lead product NX001

Tengion announces clinical, corporate and second-quarter financial updates

Amgen reports top-line results from Vectibix Phase 3 trial for head and neck cancer

AACN endorses new clinical practice guidelines developed by Renal Physicians Association

Hemodialysis with AVF depends on patient’s health insurance: Study

Affymax, Takeda announce preliminary strategy for Hematide to treat anemia in chronic renal failure patients

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Affymax reports second-quarter net income of $17.3M against loss last year

Safeguard Scientifics second-quarter aggregate revenue of partner companies increase 47% to $91.6 million

Study reveals high rate of atrial fibrillation in patients with early stages of CKD

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

New study reveals potential role of TGF-β1 in kidney disease

Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

Affymax completes sale of all auction rate securities held by UBS

New research shows Alzheimer's disease may increase risk of other potentially disabling health conditions

FDA grants Angion Biomedica's BB3 therapeutic Fast Track and Orphan Drug product designations

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Study highlights importance of individualized, patient-centered therapies

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Merck challenges New York jury decision in federal FOSAMAX retrial

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