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February 24, 2013
13:55 EDTNVSNovartis reports omalizumab improves CIU symptoms
Results from ASTERIA II, a Phase III placebo-controlled study, showed positive results in patients with moderate to severe chronic idiopathic urticaria, CIU, referred to as chronic spontaneous urticaria, CSU, outside the United States, who remained symptomatic despite treatment with approved antihistamine doses. The data were published in the New England Journal of Medicine. Omalizumab is not indicated for CIU. The primary endpoint was measured using a 21-point scale known as a weekly Itch Severity Score. The study met its primary endpoint, showing that omalizumab given at doses of 150 mg and 300 mg every four weeks led to significant improvement from baseline at Week 12 in the mean weekly ISS from baseline (approximately 14 in all treatment groups) by 8.1 (p=0.001) and 9.8 (p<0.001), respectively, compared to a 5.1 improvement in patients on placebo. The omalizumab 75 mg dose group did not demonstrate statistical significance compared to placebo for the primary endpoint. All eight pre-specified secondary endpoints in the ASTERIA II trial were met for the 150 mg and 300 mg doses, except for the 150 mg dose that did not show a significant difference from placebo in the proportion of angioedema-free days from Week 4 to Week 12 of therapy.
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May 21, 2013
07:44 EDTNVSSachs Associates to host a forum
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07:24 EDTNVSGlobal Health Care to host a conference
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May 20, 2013
07:29 EDTNVSDeutsche Bank to host a conference
dbAccess Asia Conference 2013 is being held in Singapore on May 20-22.
May 17, 2013
16:20 EDTNVSNovartis drug Afinitor extended time without disease progression in women
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May 16, 2013
08:11 EDTNVSNovartis says no intention of pursuing Actavis, Bloomberg reports
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May 15, 2013
19:37 EDTNVSNovartis weighing Actavis bid, WSJ reports
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18:17 EDTNVSNovartis weighs possible bid for Actavis, DJ reports
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May 10, 2013
05:42 EDTNVSNovartis drug Ilaris approved by FDA
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