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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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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Antares Pharma, Inc. has announced positive results from its Phase 3 study of AnturolTM Gel in patients with overactive bladder (OAB). The study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied (56 mg daily or 84 mg daily, p=0.028 and 0.033 respectively). An Open Label Extension study, evaluating long term safety remains ongoing and is scheduled to complete by Q4 2010.

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KAI Pharmaceuticals, Inc. has announced the Company has completed enrollment in a Phase 1 study of KAI-4169, a novel pharmaceutical agent for the treatment of secondary hyperparathyroidism (SHPT), which is a frequent complication of end stage renal disease (ESRD). The Phase 1 study was a double-blind, randomized, placebo-controlled, rising single intravenous (IV) dose study to assess safety and tolerability of KAI-4169 in healthy male volunteers.

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Looking to harness the body’s own immune system to target prostate cancer that has spread to the bones (metastatic) and is unresponsive to standard treatment, investigators at The Cancer Institute of New Jersey (CINJ) have just launched a clinical trial focusing on a combination of vaccine and radiation drug therapy. The goal is to see if disease progression will be further delayed by adding two different experimental injections to the standard treatment.

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Allos Therapeutics Inc announced today that the US Food and Drug Administration (FDA) has granted orphan drug designation to pralatrexate for the treatment of advanced or metastatic transitional cell carcinoma (TCC) of the urinary bladder, a form of bladder cancer. The company is currently investigating pralatrexate in a Phase 2 clinical study in patients with advanced or metastatic relapsed TCC of the urinary bladder.

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.

Quark Pharmaceuticals, Inc. announced that the independent Data Safety Monitoring Board (”DSMB”) recommended that QPI-1002 (I5NP) continue on to the next phase of clinical testing. This followed review of available safety data from two clinical trials for Quark’s siRNA QPI-1002, at doses up to 10 mg/kg, the highest evaluated to date. QPI-1002 is designed to temporarily inhibit expression of the stress-response gene, p53.

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Biomoda, Inc. announced that it has received notice of allowance for a U.S. Patent protecting the proprietary formula for the composition that binds to cancer cells which is utilized in Biomoda`s screening assay for the early detection of cancer. The U.S. Patent entitled “Method for Making 5, 10, 15, 20-Tetrakis (Carboxyphenyl) Porphine (TCPP) Solution and Composition Comprising TCPP,” describes the new formulation of the Biomoda assay trademarked under the name CyPath.

Dendreon Corp said it will submit its Provenge prostate cancer drug to the US FDA by the middle of November. The company expects to commercialize the drug by the middle of next year “to the many men with metastatic castrate-resistant prostate cancer who currently have few appealing treatment options.” The company also aims to initiate a clinical trial of its Neuvenge drug that will target bladder cancer in late 2010 or early 2011.