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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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January 16, 2015
10:10 EDTABBVAbbVie announces FDA approval of DUOPA enteral suspension
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07:04 EDTABBV, ENTAEnanta says EU grants marketing authorizations for AbbVie's Viekirax
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05:05 EDTABBVAbbVie granted marketing authorization by EC for VIEKIRAX + EXVIERA
AbbVie announced that the European Commission has granted marketing authorizations for its all-oral, short-course, interferon-free treatment of VIEKIRAX + EXVIERA. The treatment has been approved with or without ribavirin for patients with genotype 1 chronic hepatitis C virus infection, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients.1,2 Additionally, VIEKIRAX has been approved for use with RBV in genotype 4 chronic hepatitis C patients.
January 15, 2015
11:20 EDTABBVGoldman cuts J&J to sell citing competitive pressures
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January 14, 2015
12:25 EDTABBVAbbVie says pipeline is 'most robust it's ever been'
12:09 EDTABBVAbbVie says 'strongly' committed to dividend, returning cash to shareholders
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12:00 EDTABBVAbbVie says guidance to be further refined as HCV launch progresses
11:59 EDTABBVAbbVie repeats FY15 adjusted EPS view $4.25-$4.45, consensus $4.30
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January 13, 2015
12:15 EDTABBVExpress Scripts CEO says Gilead relationship 'important' going forward
Express Scripts (ESRX) CEO George Paz at the J.P. Morgan Healthcare Conference said his company's relationship with Gilead (GILD) is "important" going forward. Paz said his company's goal is not to exclude drugs. He continues to discuss Express Scripts's deal with AbbVie (ABBV) and the company's goal of saving clients money with regards to healthcare costs.

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