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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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June 30, 2015
07:33 EDTENTAEnanta appoints Nathalie Adda as SVP, chief medical officer
Enanta Pharmaceuticals (ENTA) announced the appointment of Nathalie Adda, M.D., as senior VP and chief medical officer, responsible for clinical and regulatory affairs. Most recently, Adda was chief medical officer, VP Clinical Development, Medical and Regulatory Affairs at Transgene (TRNG), where she led the Oncology and Infectious Disease programs since 2012.
07:32 EDTABBVJuno pact leaves Celgene set for growth past Revlimid, says Deutsche Bank
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June 26, 2015
12:02 EDTABBVEMA adopts positive opinion on AbbVie's Humira for acne inversa
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June 24, 2015
06:12 EDTABBVAbbVie announces new TURQUOISE-III study results
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June 22, 2015
08:56 EDTENTAEnanta management to meet with JPMorgan
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June 18, 2015
07:36 EDTABBVReceptos remains an attractive takeover candidate, says Leerink
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June 17, 2015
10:00 EDTABBVOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: AbbVie (ABBV) initiated with an Overweight at Piper Jaffray... Arista Networks (ANET) initiated with a Buy at Sterne Agee CRT... Astec (ASTE) initiated with a Buy at Maxim... Bristol-Myers (BMY) initiated with an Underweight at Piper Jaffray... Community Healthcare (CHCT) initiated with an Outperform at Oppenheimer... Eli Lilly (LLY) initiated with an Overweight at Piper Jaffray... Fitbit (FIT) initiated with a Buy ahead of IPO at Dougherty... Hortonworks (HDP) initiated with a Buy at Mizuho... II-VI (IIVI) initiated with a Buy at Benchmark Co.... J Sainsbury (JSAIY) initiated with an Underperform at Credit Suisse... McDermott (MDR) initiated with an Outperform at Cowen... Merck (MRK) initiated with a Neutral at Piper Jaffray... Molina Healthcare (MOH) initiated with a Buy at UBS... Pacific DataVision (PDVW) initiated with a Buy at Canaccord... Pfizer (PFE) initiated with an Overweight at Piper Jaffray... Quest Resource (QRHC) initiated with a Buy at Roth Capital... Regional Management (RM) initiated with a Buy at Janney Capital... Rofin-Sinar (RSTI) initiated with a Buy at Benchmark Co.... Salesforce (CRM) initiated with a Neutral at Exane BNP Paribas... Sprouts Farmers Markets (SFM) initiated with a Neutral at Cleveland Research... Tesco (TSCDY) initiated with an Underperform at Credit Suisse... WM Morrison (MRWSY) initiated with a Neutral at Credit Suisse... WWE (WWE) initiated with a Buy at BTIG... World Acceptance (WRLD) initiated with a Buy at Janney Capital... Zafgen (ZFGN) initiated with a Buy at SunTrust.
07:33 EDTABBVOraSure 44% year-to-date selloff overdone, says Jefferies
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07:25 EDTABBVPiper calls Bristol 'modestly overvalued,' starts shares with sell
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05:32 EDTABBVAbbVie initiated with an Overweight at Piper Jaffray
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