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News Breaks
June 17, 2014
05:40 EDTENTA, ABBVAbbVie announces EMA validation of MMAs for GT1 HCV treatment
AbbVie (ABBV) and Entana Pharmaceuticals (ENTA) announced that the Marketing Authorization Applications, or MAAs, for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1, or GT1, hepatitis C virus, or HCV, infection have been validated and are under accelerated assessment by the European Medicines Agency, or EMA. Accelerated assessment, which is designated to new medicines of major public health interest, was granted by the EMA for AbbVie's investigational HCV regimen in May. Validation of the MAAs confirms that the submissions are complete and starts the EMA's centralized review process. If approved, AbbVie's regimen could be available for marketing in the European Union in 1Q15. The MAAs were submitted on May 8 and are supported by data from a large clinical program including six Phase III studies of more than 2,300 GT1 patients in over 25 countries. Review of the MAAs will be conducted under the centralized licensing procedure, which, when finalized, provides marketing authorizations in all 28 member states of the EU. On June 13, AbbVie announced that the New Drug Application for AbbVie's regimen was accepted and granted priority review by the FDA.
News For ABBV;ENTA From The Last 14 Days
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April 23, 2015
09:04 EDTABBVAbbVie says continues to see strong underlying demand for Humira
Comment from earnings conference call.
08:19 EDTENTA, ABBVEnanta announces FDA grants priority review for AbbVie treatment regimen
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07:52 EDTABBVAbbVie expects Pharmacyclics transaction to close in Q2
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07:51 EDTABBVAbbVie raises FY15 adjusted EPS to $4.10-$4.30 from $4.05-$4.25, consensus $4.19
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07:51 EDTABBVAbbVie reports Q1 HUMIRA sales up 26% to $3.11B
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07:49 EDTABBVAbbVie reports Q1 adjusted EPS 94c, consensus 85c
Reports Q1 revenue $5.04B, consensus $4.98B
April 22, 2015
15:50 EDTABBVNotable companies reporting before tomorrow's open
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14:08 EDTABBVEarnings Watch: AbbVie's Humira sales will be focus for Q1
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08:55 EDTABBVDeutsche Bank biotech analyst holds an analyst/industry conference call
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07:07 EDTABBVEuropean Association for the Study of the Liver to hold annual meeting
50th Annual Meeting of EASL will be held in Vienna, Austria on April 22-26.
April 20, 2015
14:32 EDTABBVPharmacyclics patent for Imbruvica challenged by Hayman Capital's Bass
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07:20 EDTABBVAmerican Association for Cancer Research to hold annual meeting
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07:18 EDTABBVAmerican Academy of Neurology to hold annual meeting
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April 17, 2015
16:50 EDTABBVAbbVie extends exchange offer to acquire Pharmacyclics
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April 15, 2015
19:08 EDTABBV, ENTAEnanta confirms AbbVie hepatitis C treatment granted priority review in Japan
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19:03 EDTABBVAbbVie's chronic hepatitis C treatment granted priority review in Japan
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April 13, 2015
14:07 EDTABBVEarnings Watch: Johnson & Johnson shares down slightly since last earnings
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10:00 EDTABBVOn The Fly: Analyst Upgrade Summary
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08:34 EDTABBVAbbVie upgraded on Imbruvica outlook at BMO Capital
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07:02 EDTABBVAbbVie upgraded to Outperform from Market Perform at BMO Capital
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