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.

PercuVision, which has developed a device that guides medical staff through a urethral catheterizations, has received FDA clearance to market its device. The $29,000 device is essentially a catheter with a fiber-optic flashlight and camera at the end. The company built its DirectVision System to be a “visual guide” through the urethra that will cut down on problematic insertions into the urethra and cut health-care costs by eliminating costly procedures from catheter-related damage.

The FDA has granted 510(k) marketing clearance to EDAP for its newly designed, high-end Sonolith I-Sys robotized device. Sonolith I-Sys has been developed to provide a highly effective product configuration to address what is one of the largest lithotripsy markets in the world. The integrated lithotripter utilizes EDAP’s unique and patented electroconductive technology, an advanced shockwave approach differentiated by its superior ability to successfully disintegrate urinary stones in association with combined x-ray or ultrasound systems.

FDA has issued a warning about Libipower Plus, which contains untested versions of a powerful prescription medication used to treat impotence in men. The manufacturer of this dangerous product Haloteco, have issued an immediate complete recall of Libipower Plus. The FDA has tested the product in their own laboratories and found it to contain a version of the active ingredient of the erectile dysfunction drug Cialis.

Novadaq Technologies Inc, a developer of real-time imaging systems used in the operating room, announced that its SPY endoscopic imaging system has received 510(k) clearance from the US Food and Drug Administration for use during minimally invasive surgery (MIS). Novadaq’s SPY “scope” combines the traditional features of a state of the art, high definition standard endoscope with the fluorescence capabilities of the SPY imaging system, which is currently used in a variety of open surgical procedures.

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.

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.

The U.S. FDA has granted Bioniche Life Sciences’ therapy for first-line non-muscle-invasive bladder cancer Fast Track designation. Later this year, the company will begin a Phase III clinical trial comparing Urocidin(TM), a formulation of its Mycobacterial Cell Wall-DNA Complex (MCC), to the current standard therapy in patients with non-muscle-invasive bladder cancer at high risk of recurrence or progression.