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News Breaks
June 17, 2014
05:40 EDTABBV, ENTAAbbVie 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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March 4, 2015
10:01 EDTENTAOn The Fly: Analyst Initiation Summary
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09:07 EDTABBVFDA making testosterone product makers change labeling
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07:10 EDTABBVCowen to hold a conference
35th Annual Health Care Conference is being held in Boston on March 2-4 with webcasted company presentations to begin on March 4 at 8 am; not all company presentations may be webcasted. Webcast Link
05:37 EDTENTAEnanta initiated with an Equal Weight at Barclays
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March 3, 2015
11:46 EDTABBVLeerink biotech analyst holds an analyst/industry conference call
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February 23, 2015
11:19 EDTABBV, ENTAEnanta announces JAMA publication of AbbVie VIEKIRA PAK study results
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11:04 EDTABBVAbbVie reports VIEKIRA PAK HPV/HIV co-infection study results published
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February 20, 2015
10:33 EDTABBVBattleground update: AbbVie named top global pick at Jefferies
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07:23 EDTABBVAbbVie replaces Pfizer as top global pharma pick at Jefferies
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February 19, 2015
12:13 EDTABBVAbbVie increases quarterly dividend 4% to 51c per share
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