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July 17, 2014
13:34 EDTSHPGShire reports results from Vyvanse vs. Concerta studies in adolescents with ADHD
Shire announced top-line results from two Phase 4 efficacy and safety studies of Vyvanse compared with Concerta with a placebo reference arm in adolescents aged 13-17 diagnosed with Attention-Deficit/Hyperactivity Disorder. In SPD489-406, the forced-dose titration study, Vyvanse was found to be statistically superior to Concerta on the primary efficacy analysis with mean reductions on the ADHD RS-IV total score of 25.4 and 22.1 points, respectively. In SPD489-405, the dose optimization study, neither Vyvanse nor Concerta was found to be statistically superior to the other on the primary efficacy analysis, with a larger mean improvement found for Vyvanse than Concerta. The primary efficacy endpoint for both studies was defined as the change from baseline in ADHD-RS-IV total score at Week 6 and Week 8, respectively. In both studies, the types of adverse events appear to be generally consistent with the known safety profile for Vyvanse established in studies of adolescents with ADHD. Shire plans to submit the efficacy and safety data from the two studies for presentation at a future scientific congress.
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September 15, 2014
10:55 EDTSHPGRegulators to determine AbbVie, Shire deal by next month, Reuters says
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08:01 EDTSHPGShire announces FDA acceptance for filing of sNDA for Vyvanse
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September 10, 2014
08:37 EDTSHPGMedgenics appoints Scott Applebaum as Chief Legal Officer
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07:06 EDTSHPGSangamo plans to submit IND application for hemophilia B in 2Q15
Sangamo BioSciences (SGMO) plans to submit an Investigational New Drug application for the treatment of hemophilia B in Q2 2015. This program, partnered with Shire (SHPG), is the first therapeutic application of Sangamo's zinc finger nuclease-mediated In Vivo Protein Replacement Platform. Sangamo is developing the IVPRP as a generally applicable strategy to provide a one-time, permanent genetic cure for monogenic diseases that are currently managed by protein replacement therapy, which involves costly repeat infusions over the lifetime of the patient.
September 3, 2014
12:19 EDTSHPGOptions with increasing implied volatility
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