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News Breaks
July 14, 2014
07:07 EDTSLXP, PGNXFDA says RELISTOR can be approved on data submitted in sNDA
Salix Pharmaceuticals (SLXP) and Progenics Pharmaceuticals (PGNX) announced that the Food and Drug Administration has informed Salix that RELISTOR can be approved on the data submitted in the sNDA. The FDA Office of Drug Evaluation III responded to the company’s formal appeal filed in response to the Complete Response Letter of July 27, 2012 to the supplemental NDA ) for RELISTOR. The Agency’s letter stated that, “Salix’s request that FDA approve the supplemental NDA for RELISTOR subcutaneous injection for the treatment of opioid-induced constipation in patients with chronic non-cancer pain based on the submitted data is granted.” This request for a proposal for a post-marketing observational study is in accordance with recommendations of the June 11-12, 2014 meeting of the Anesthetic and Analgesic Drug Product Advisory Committee. Salix will work with the DGIEP in an effort to provide information to the division that will enable the division to approve RELISTOR for use by patients with chronic non-cancer pain and experiencing OIC.
News For SLXP;PGNX From The Last 14 Days
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October 23, 2014
18:18 EDTSLXPGlenview Capital acquires stake in Actavis, Bloomberg reports
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October 21, 2014
07:07 EDTSLXPSalix to present results of TARGET 3 study with Rifaximin 550mg for IBS
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October 20, 2014
08:19 EDTPGNXProgenics presents data from Phase 2 trial of 1404 PSMA imaging agent
Progenics Pharmaceuticals announced that data from a Phase 2 trial of its PSMA imaging agent candidate, 1404, have been presented at the 27th Annual European Association of Nuclear Medicine Congress being held in Gothenburg, Sweden. 1404 is a targeted small molecule designed to "visualize" prostate cancer by targeting prostate specific membrane antigen. "The Phase 2 data are quite impressive and demonstrate how SPECT/CT with 1404 may provide a more accurate assessment of the presence, location and extent of prostate cancer," said Dr. Dabasi. Gabriella Dabasi, Ph.D. presented, "1404 may provide prognostic information for both primary and metastatic disease in a single procedure, which could greatly enhance the clinical decision-making process. There is a strong rationale for continued development of this promising molecular imaging agent." In the Phase 2 trial, SPECT/CT imaging with 1404 showed 94% sensitivity in detecting and imaging cancer in the prostate gland of high-risk patients prior to prostatectomy. In addition, 1404 was more sensitive than MRI in detecting primary prostate cancer and was a good predictor of lymph node involvement at prostatectomy. SPECT/CT imaging with 1404 identified 14 more patients with suspicious lymph node sites than MRI. Uptake of 1404 in the lobes of the prostate gland showed a highly significant correlation with Gleason score. The data also showed uptake of 1404 in the primary tumor was significantly lower in treated patient, corresponding to a decrease in PSA over time observed in these treated patients.
October 16, 2014
15:10 EDTSLXPAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.

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