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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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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A California-based food company announced a voluntary recall of romaine lettuce salad products suspected of being tainted with E. Coli O157:H7. The company said it ordered the recall after a random test by the U.S. Food and Drug Administration detected E. coli O157:H7 in one package of Fresh Express Hearts of Romaine lettuce salad. While most healthy adults recover within a week, young children and elderly are at higher risk for developing Hemolytic Uremic Syndrome (HUS) as a result of the infection. HUS can lead to serious kidney damage and death.

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Watson Pharmaceuticals Inc (WPI) said its unit applied for Food and Drug Administration approval of a generic version of Genzyme Corp.’s (GENZ) Renvela kidney-failure product. Renvela is a phosphate-binder, which dialysis patients need to absorb excess phosphorous in the blood, a problem associated with increased risk of cardiac issues.
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Federal regulators are warning doctors not to use the malaria drug Qualaquin to treat leg cramps, due to the risk of potentially life-threatening blood disorders and kidney damage. In its communication, the FDA has noted that doctors have been prescribing Qualaquin “off label” for the treatment of leg cramps, but they warn that the drug should not be prescribed for this purpose because it carries a risk of life-threatening blood and kidney

Cancer patients being treated by a drug called Avastin (bevacizumb) are at a higher risk of developing a kidney problem known as proteinuria, according to a study led by Shenhong Wu of Stony Brook Medical Center. Proteinuria can eventually cause significant damage to kidney and in severe cases, can lead to kidney failure.

Recent studies conducted by researchers at Johns Hopkins University show that obese people have an increased risk of developing common kidney cancer, kidney stones apart from being at a high risk of getting a stroke. A study involving 1,640 participants studied the effects of weight on kidney cancer. The average age of patients was 62 and all participants had kidney tumors. The study showed that patients with a BMI of 30 or higher were 48% more likely to develop clear-cell renal cell cancer (RCC). With every 1 point increase in BMI, obese patients increased their odds of getting kidney cancer by 4%. Out of all the participants, 67% of the obese patients had kidney cancer compared to 57% of non-obese patients.

Pluromed Inc won 510(k) approval from the FDA for its Backstop polymer gel plug. The plug is used during lithotripsy kidney stone treatments that use laser or other energy sources to break up the stones. Backstop uses Pluromed’s Rapid Transition Polymers, which are liquid at low temperatures but gel at 98.6 degrees Fahrenheit. During the lithotripsy, the gel forms a plug above the stones, preventing them from moving during the procedure. Once the stones are broken, saline is used to dissolve the plug.

LifeCycle Pharma A/S has announced the enrollment of the first patient in its Phase 3 clinical trial program for use of LCP-Tacro™ in the prevention of organ rejection in stable kidney transplant patients. The clinical trial protocol has been reviewed by FDA, and LCP expects to enroll approximately 300 stable kidney transplant patients in the program. The study will be conducted at approximately 50 sites in U.S. and Europe and the clinical trial results are expected by second half of 2010.

Questcor Pharmaceuticals, Inc. has announced that it will be considering its principal product H.P. Acthar for use in a new area – nephrotic syndrome. In this condition, there is excessive spilling of protein into the urine from the kidneys of the patient. Acthar is specifically indicated to deal with this condition (proteinuria). Questcor is in discussions with nephrologists about the possible therapeutic application of Acthar. A broader indication for the product is expected in future.