Urology Product Guide

Bladder Cancer Risk May Be Decreased By Increasing Selenium Intake

Seth Sullivan — Fri, 03 Sep 2010 07:08:15 +0000

A common mineral may provide protection against bladder cancer. According to results of a study published in the September issue of Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research, selenium intake is associated with decreased risk of bladder cancer. Selenium is an essential micronutrient that is incorporated into about 25 proteins, called selenoproteins. Most of these selenoproteins are enzymes with antioxidant properties that prevent cellular damage.

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Amneal Announces FDA Approval For Spironolactone HCl Tablets

Seth Sullivan — Fri, 03 Sep 2010 07:04:14 +0000

Amneal Pharmaceuticals, LLC has announce that it has received U.S. FDA approval to manufacture Spironolactone HCl tablets in 25 mg, 50 mg and 100 mg strengths effective July 2, 2010. The Amneal generic is an AB-rated, therapeutically equivalent alternative to Aldactone® (a registered trademark of Pharmacia & Upjohn, Inc., a unit of Pfizer Inc.). Annual U.S. sales of Spironolactone HCl were $91 MM as of December 2009 according to IMS Health market data.

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Coverage Initiated By Two Regional Medicare Carriers For Posterior Tibial Nerve Stimulation (PTNS)

Seth Sullivan — Thu, 26 Aug 2010 14:16:26 +0000

Uroplasty, Inc. has announced that Noridian Administrative Services, LLC and Palmetto GBA, South Carolina, both regional Medicare carriers, now cover percutaneous, posterior tibial nerve stimulation (PTNS) using the Urgent® PC Neuromodulation System for the treatment of the symptoms of overactive bladder. Noridian administers benefits for Medicare beneficiaries in North and South Dakota, Montana, Wyoming, Utah and Arizona. The Palmetto GBA policy covers Medicare beneficiaries in South Carolina.

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3SBio And Isotechnika Pharma Announce Strategic Partnership To Develop And Commercialize Voclosporin In China

Seth Sullivan — Thu, 26 Aug 2010 14:13:16 +0000

3SBio Inc. and Isotechnika Pharma Inc. have announced the signing of a development and commercialization agreement for voclosporin, a next generation calcineurin inhibitor being developed for use in the prevention of organ rejection following transplantation and the treatment of autoimmune diseases. 3SBio will be responsible for the clinical development, registration and commercialization of voclosporin in China. Isotechnika will provide, under separate agreement, commercial supply to 3SBio on a cost-plus basis.

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NephRx Corp. Receives Orphan Drug Designation For NX001 For Prevention Of Delayed Kidney Graft Function

Seth Sullivan — Fri, 20 Aug 2010 07:53:25 +0000

NephRx Corporation announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead product NX001 for the prevention of delayed graft function (DGF) 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. DGF affects an estimated 20-25% of the approximately 14,000 renal transplants performed annually in the U.S.

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FDA Approves Longer Use Of Valcyte(R) For Adult Kidney Transplant Patients At High Risk Of Developing Cytomegalovirus (CMV) Disease

Seth Sullivan — Fri, 20 Aug 2010 07:50:02 +0000

Genentech, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease. The supplemental approval is based on data that showed longer prophylactic treatment with Valcyte reduced the incidence of CMV disease in high-risk adult kidney transplant patients from 36.8 percent to 16.8 percent at one year after receiving a transplanted kidney.

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GYNECARE TVT EXACT(TM) Continence System Joins Ethicon GYNECARE TVT(TM) Family Of Products Tension Free Support For Incontinence

Seth Sullivan — Fri, 13 Aug 2010 12:58:06 +0000

Ethicon, Inc. has announced the availability of the GYNECARE TVT EXACT™ Continence System in the United States. GYNECARE TVT EXACT™ is a new minimally invasive surgical tool used in an outpatient setting for the treatment of stress urinary incontinence (SUI), a condition that affects one in three women in the U.S. The product’s integrated system offers an ergonomically designed handle to improve physician control during surgery.

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Augmenix Announces First Commercial Use Of SpaceOAR(TM) System For Prostate-Rectum Separation In Prostate Cancer Patients

Seth Sullivan — Fri, 13 Aug 2010 12:51:49 +0000

Augmenix, Inc. has announced that Aachen University Hospital, Aachen, Germany, performed a commercial implantation of the company’s CE Mark approved SpaceOAR™ System. The SpaceOAR hydrogel (from spacing Organs At Risk) is designed to be a tissue compatible, absorbable spacer to reduce radiation injury to healthy tissues. Since the prostate lies directly over the rectum, prostate radiation treatment always results in some rectal radiation which can lead to pain, rectal bleeding, urgency, and other serious complications.

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Five New Genetic Variations Associated With Prostate Cancer Uncovered In Study On Japanese Men

Seth Sullivan — Wed, 04 Aug 2010 05:24:07 +0000

A genome-wide study on Japanese subjects has identified 5 new genetic variations linked to prostate cancer and revealed differences and similarities between Europeans and Asians in susceptibility to the disease. Reported in Nature Genetics, the findings offer a first-ever glimpse of the genetic basis for prostate cancer susceptibility in a non-European population. Despite having the lowest rates of prostate cancer in the world, Asian countries have experienced a rapid rise in incidence of the disease.

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Bladder Cancer Risk May Be Increased By Certain Meat Components

Seth Sullivan — Wed, 04 Aug 2010 05:16:54 +0000

A new study suggests that consuming specific compounds in meat related to processing methods may be associated with an increased risk of developing bladder cancer. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the findings may be relevant for understanding the role of dietary exposures in cancer risk. Eating red and processed meats has been linked to an increased risk of developing several different types of cancer.

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