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.

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.

The FDA has approved the drug bevacizumab (Avastin), in combination with interferon alfa, as a treatment for metastatic renal cell carcinoma. Avastin is already indicated for the treatment of metastatic colorectal carcinoma, nonsmall cell lung cancer and glioblastoma, usually in combination with other agents. The latest approval was based on results from a trial of 649 people who had metastatic renal cell carcinoma and had undergone nephrectomy.

US health regulators have granted fast-track designation to Spectrum Pharmaceuticals Inc’s EOquin (apaziquone) drug candidate. EOquin is the experimental treatment for bladder cancer that has not that has not yet spread deep into the muscle layer. The non-muscle invasive type of bladder cancer accounts for 70% of the new diagnoses and said it affects more than a million patients in the US and Europe. Fast-track designation is designed to expedite the review of drugs to treat serious diseases and fill unmet medical needs.

Procter & Gamble Pharmaceuticals has launched Asacol HD (mesalamine) delayed-release tablets for the treatment of moderately active ulcerative colitis (UC), a form of inflammatory bowel disease. UC involves inflammation of the lining of the colon and rectum and is typically characterized by flares followed by periods of remission. Asacol HD 4.8 g/day 800 mg tablet was approved by the US FDA.

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.

The U.S. Food and Drug Administration has approved Watson Laboratories’ Rapaflo (silodosin) capsules for the treatment of symptoms of benign prostatic hyperplasia (BPH). Having high affinity for α-receptors concentrated in the prostate, the blocker binds them to smoothen muscles in the tissues. This relaxes them, improving flow of urine and reducing symptoms of BPH such as retrograde ejaculation, dizziness etc.

According to the results of a comparative trial at Clayton Research Institute in St. Louis, Missouri, single-day famciclovir (1000 mg twice daily) was as effective and safe as 3-day valacyclovir (500 mg administered twice daily) for the treatment of genital herpes. Thus, it represents a more convenient medication for immuno-competent adults facing the problem of recurrent genital herpes. An effective short-course treatment can reduce the unwanted sequelae related to recurrences considerably. Novartis, the maker of famciclovir (brand name – Famvir), supported the study.