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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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February 4, 2016
16:00 EDTSHPGShire's NDA for lifitegrast for dry eye resubmssion acknowledged by FDA
Shire announced that the FDA has acknowledged receipt of the resubmission of the New Drug Application for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter received from the FDA on October 16, 2015 that requested an additional clinical study and more information related to product quality. The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act goal date of July 22.
February 3, 2016
08:07 EDTSHPGMedgenics names Brian Piper to succeed John Leaman as CFO
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February 2, 2016
09:46 EDTSHPGIntercept rumored to draw interest from many suitors, Daily Mail says
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January 28, 2016
10:05 EDTSHPGHigh option volume stocks
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January 25, 2016
07:02 EDTSHPGShire resubmits NDA for lifitegrast to FDA
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