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FDA acknowledges Dendreon's amended BLA for PROVENGE as a complete response

20. November 2009 09:23
Dendreon Corporation today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC). [More]

Findings suggest athletes abuse non-approved therapeutic compounds for performance enhancing effects

19. November 2009 05:44
Researchers from the German Sport University Cologne in Germany found that non-steroidal and tissue-selective anabolic agents such as Selective Androgen Receptor Modulators (SARMs) are being sold on the black market for their performance enhancing qualities. [More]

Posted in: Pharmaceutical News

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Once-a-day dosing clinical study of udenafil for erectile dysfunction completed

19. November 2009 00:44
Dong-A Pharmaceutical Co., Ltd. and Dong-A PharmTech, Co. Ltd. announced today that it has completed a 240 patient once-a-day dosing clinical study of udenafil, its new long acting phosphodiesterase type 5 (PDE-5) inhibitor for erectile dysfunction (ED). [More]

Protox Therapeutics announces financial results for the third quarter ended September 30, 2009

16. November 2009 07:42
Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced financial results for the third quarter, ended September 30, 2009. [More]

Aeterna Zentaris reports consolidated revenues of $8.6 million for third quarter 2009

11. November 2009 07:39
AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrinology and oncology, today reported financial and operating results as at and for the three-month and nine-month periods ended September 30, 2009. [More]

Global demand for nutraceutical ingredients to reach $21.8 billion in 2013

11. November 2009 06:23
Demand for nutraceutical ingredients worldwide is projected to advance 6.2 percent annually to $21.8 billion in 2013, serving a $236 billion global nutritional product industry. [More]

Warner Chilcott initiates phase III trial of erectile dysfunction drug udenafil

4. November 2009 23:47
Dong-A PharmTech Co. Ltd., announced that its U.S. partner, Warner Chilcott plc, has initiated two, phase III trials for udenafil, a new long acting drug under development for erectile dysfunction (ED). Each randomized, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of udenafil, an orally administered selective inhibitor of phosphodiesterase versus placebo. [More]

Dendreon submits an amended BLA for PROVENGE active cellular immunotherapy

2. November 2009 10:36
Dendreon Corporation today announced that it has completed the submission of the amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T), the Company's lead investigational product, to the U.S. Food and Drug Administration (FDA). Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC). [More]

Protox Therapeutics to present Phase 2 study data of PRX302 for benign prostatic hyperplasia

29. October 2009 07:52
Protox Therapeutics Inc., a leader in the development of receptor targeted fusion proteins, today announced that detailed data from its open-label Phase 2 clinical study of PRX302 in patients with moderate to severe benign prostatic hyperplasia (BPH) will be presented at the 30th World Congress of the Société Internationale d'Urologie Conference. [More]

AbbeyMoor Medical's The Spanner temporary prostatic stent insertion procedure receives Category I CPT code

15. October 2009 02:07
AbbeyMoor Medical Inc. announced today they have been granted a Category I CPT code by the American Medical Association (AMA) for The Spanner(TM) temporary prostatic stent insertion procedure. This important action, effective in January 2010, upgrades The Spanner from a Category III emerging technology procedure code to a Category I procedure code for established procedures. [More]

Urodynamix Technologies commences uroNIRS 2000 pilot program

8. October 2009 09:37
Urodynamix Technologies Ltd. today announces that it has commenced a pilot sales and marketing program with Cardinal Health for its uroNIRS 2000, an innovative technology for the non-invasive diagnosis of bladder conditions. The 90-day pilot program will be used to by Urodynamix and Cardinal Health to evaluate the viability of adding the uroNIRS 2000 to Cardinal Health's catalogue of offerings to the urology market. [More]

Impax Laboratories settles FLOMAX litigation, to launch generic tamsulosin hydrochloride product

7. October 2009 07:40
Impax Laboratories, Inc. today announced that it has reached agreement with Astellas Pharma Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. to settle pending U.S. litigation with regard to US Patent No. 4,703,063 for FLOMAX® (generic name: tamsulosin hydrochloride) capsules through the entry of a consent judgment confirming the validity and infringement of the patent. FLOMAX® is a treatment for the functional symptoms of benign prostatic hyperplasia. [More]

Posted in: Medical Patent News | Pharmaceutical News

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FDA grants Impax tentative approval of ANDA for FLOMAX generic version

5. October 2009 08:44
Impax Laboratories, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company’s Abbreviated New Drug Application (ANDA) for generic version of FLOMAX® (tamsulosin hydrochloride) 0.4mg capsules. Boehringer Ingelheim Pharmaceuticals, Inc. markets FLOMAX® for the functional symptoms of benign prostatic hyperplasia. [More]

Posted in: Medical Condition News | Pharmaceutical News

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Neurocrine Biosciences enters into an amendment to its facility lease agreement

5. October 2009 07:01
Neurocrine Biosciences, Inc. announced today that the Company has entered into an amendment to its facility lease agreement. The amendment eliminates approximately 70,000 square feet of leased space. [More]

Posted in: Business / Finance

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Urologix receives approval for stock listing transfer from Nasdaq Global Market to Nasdaq Capital Market

5. October 2009 05:33
Urologix®, Inc., received approval on October 1, 2009 from The Nasdaq Stock Market to transfer the listing of its common stock from The Nasdaq Global Market to The Nasdaq Capital Market. [More]

Posted in: Business / Finance

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