OrBIT Study Long Term Results Show Sustained Therapeutic Effect Of Percutaneous Tibial Nerve Stimulation At 12 Months

Uroplasty, Inc. (NYSE Amex: UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, highlighted the 12-month results of the OrBIT Trial of its Urgent® PC Neuromodulation System that will be published in the January 2010 print edition of THE JOURNAL OF UROLOGY®. The Urgent PC System is [...]

Transcept Pharmaceuticals Scheduled To Meet With FDA To Discuss Intermezzo(R) Complete Response Letter

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). As previously announced, the Complete Response Letter, received by Transcept on October 28, [...]

Strativa Pharmaceuticals’ Development Partner, BioAlliance Pharma, Presents Phase III Study Results Of Miconazole Lauriad(R)

Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX), announced that its development partner BioAlliance Pharma SA presented Phase III study results for miconazole Lauriad(R) mucoadhesive buccal tablets (MBT) that demonstrate noninferiority to clotrimazole troches for oropharyngeal candidiasis (OPC), an opportunistic infection of the mouth and throat. The data from this [...]

FDA Accepts Drug Application For Miconazole Lauriad(R) To Treat Oropharyngeal Candidiasis

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for miconazole Lauriad((R)) mucoadhesive buccal tablets (MBT) to treat oropharyngeal candidiasis (OPC). Miconazole MBT delivers the antifungal miconazole via a mucoadhesive [...]

FluoroPharma To Present Phase I Study Results Of Novel Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) Tracer

FluoroPharma Inc., a company developing breakthrough PET molecular imaging agents, announced that it will present Phase I data relating to the safety, dosimetry, and pharmacokinetics in human subjects of BFPET, its novel 18-F labeled PET tracer for myocardial perfusion imaging, at the Society of Nuclear Medicine 2009 Annual Meeting in Toronto.