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Stock Market & Financial Investment News

News Breaks
May 19, 2014
05:30 EDTSHPGShire plans to submit NDA for lifitegrast to FDA
Following a May 15 meeting with the FDA, Shire announces that it intends to submit a New Drug Application, or NDA, for lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults in 1Q15. In parallel to preparing for the NDA submission, Shire will be assessing the need for gathering additional clinical data in support of the U.S. and potential international regulatory submissions.
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July 23, 2015
14:01 EDTSHPGShire receives 'positive opinion' on Intuniv from CHMP
Shire announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of the once-daily, non-stimulant Intuniv, or guanfacine hydrochloride extended release, for the treatment of attention deficit/hyperactivity disorder in children and adolescents. The positive opinion is based on results from three Phase 3 pivotal studies investigating the short- and long-term safety and efficacy of Intuniv in children and adolescents. The European Commission will now consider the CHMP positive opinion in its decision of whether to grant marketing authorisation for Intuniv in Europe, said Shire.
07:25 EDTSHPGShire raises FY15 EPADS growth view to mid-to-high single digit percentage
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07:22 EDTSHPGShire reports Q2 EPS $2.63, consensus $2.81
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