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News Breaks
March 26, 2013
08:05 EDTAUXL, BSTCBioSpecifics announces postive data from Xiaflex Phase IIa study
BioSpecifics (BSTC) announced positive, statistically significant top-line data from the Phase IIa study of Xiaflex for the potential treatment of frozen shoulder. This open-label, controlled dose-ranging Phase IIa study was conducted by BioSpecifics' strategic partner Auxilium (AUXL) and was designed to assess the safety and efficacy of Xiaflex for the treatment of Stage 2 unilateral idiopathic frozen shoulder in comparison to an exercise-only control group. Both the 0.58mg and 0.58mg dosing arms showed positive, statistically significant improvement from baseline in forward flexion vs. the exercise-only group. There were no drug-related serious adverse events reported and all treatment-related adverse events were consistent with XIAFLEX use in other approved and potential indications.
News For BSTC;AUXL From The Last 14 Days
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November 21, 2014
08:35 EDTAUXL, BSTCBioSpecifics announces new data on XIAFLEX for Peyronie's Disease
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November 20, 2014
07:09 EDTAUXLAuxilium presents STENDRA data at SMSNA meeting
Auxilium Pharmaceuticals announced that data were presented regarding the use of STENDRA tablets for the treatment of erectile dysfunction at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America held in Miami from November 20-23. A post-hoc analysis of data from a placebo-controlled, Phase 4 study of STENDRA evaluated men who had at least one attempt at intercourse within approximately 15 minutes of taking the medication. The STENDRA 100 and 200mg doses demonstrated statistically significant improvement in onset of erectogenic effect at approximately 15 minutes compared to placebo, with a mean per-patient proportion of sexual attempts that resulted in at least one successful intercourse within approximately 15 minutes after dosing of 73.3% and 71.5%, respectively. Results of a study examining the proportion of men with ED who reported successful intercourse within the first three doses of STENDRA showed more than 60% of patients reported successful intercourse within the first three doses of STENDRA. This compares to about 40% with placebo. A higher percentage, or 75% for STENDRA vs. 56% for placebo, also reported success after any dose.
07:07 EDTAUXLAuxilium presents XIAFLEX for Peyronie's Disease data
Auxilium Pharmaceuticals announced presentations of data from new studies, as well as new analyses of data from the Phase 2 and the pivotal Phase 3 IMPRESS trials evaluating XIAFLEX for the treatment of Peyronie's disease, at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America held in Miami from November 20-23. Data were presented providing further evidence that PD bother is clinically significant and may be a useful measure in clinical practice when treating PD. Data were also presented suggesting that improvements in PD bother are correlated with improvements in penile curvature deformity.
November 19, 2014
07:33 EDTAUXLEndo, Auxilium receive early termination of HSR waiting period for deal
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November 18, 2014
07:02 EDTAUXLAntares Pharma names James Fickenscher as SVP, CFO
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November 10, 2014
08:14 EDTBSTCBioSpecifics reports Q3 EPS 20c, consensus 19c
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