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AbbVie Inc (ABBV.K)

ABBV.K on New York Consolidated

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25 Jul 2016
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Latest Key Developments (Source: Significant Developments)

Abbvie says CHMP grants positive opinion for shorter treatment duration with VIEKIRAX
Monday, 25 Jul 2016 04:00am EDT 

Abbvie Inc : CHMP grants positive opinion for shorter treatment duration with Abbvie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) for patients with genotype 4 chronic hepatitis C with compensated cirrhosis (child-pugh a) .Says VIEKIRAX with RBV is currently approved in European Union for GT4 patients with compensated cirrhosis for 24 weeks.  Full Article

Ablynx CEO sees potential multibillion-dollar opportunity for drug
Thursday, 7 Jul 2016 04:22am EDT 

Ablynx CEO Edwin Moses told Reuters: Sales opportunity for vobarilizumab could be in "billions" of dollars in rheumatoid arthritis & other diseases . AbbVie will decide later in 2016 whether to license vobarilizumab, after second RA trial results expected in August Further company coverage: [ABLX.BR] (Reporting by UK bureau) ((uk.online@reuters.com;)).  Full Article

Biogen and Abbvie's multiple sclerosis drug approved in EU
Tuesday, 5 Jul 2016 08:00am EDT 

Abbvie Inc :Biogen and Abbvie's once-monthly Zinbryta™ (Daclizumab) approved in European Union for treatment of multiple sclerosis.  Full Article

Biogen and AbbVie's drug approved in EU
Tuesday, 5 Jul 2016 08:00am EDT 

Biogen Inc : Biogen and AbbVie's once-monthly zinbryta(tm) (daclizumab) approved in European Union for treatment of multiple sclerosis . Zinbryta significantly reduced multiple measures of disease activity in patients with relapsing forms of MS .Targeted mechanism of action of zinbryta did not cause broad, prolonged depletion of studied immune cell types.  Full Article

Abbvie announces fourth breakthrough therapy designation granted by FDA
Wednesday, 29 Jun 2016 07:30am EDT 

AbbVie Inc : Abbvie announces fourth breakthrough therapy designation granted by the U.S. Food and drug administration (FDA) for ibrutinib (imbruvica) for chronic graft-versus-host-disease (CGVHD), a rare condition with limited treatment options . FDA also granted therapy orphan drug designation (ODD) for condition . Imbruvica is jointly developed and commercialized by Pharmacyclics LLC, an Abbvie company and Janssen Biotech Inc .Versus-Host-Disease (CGVHD), a rare condition with limited treatment options.  Full Article

Infinity regains worldwide rights to duvelisib; ends collaboration with AbbVie
Tuesday, 28 Jun 2016 06:55am EDT 

Infinity Pharmaceuticals Inc : Infinity undertakes restructuring of workforce . Infinity will also reduce its workforce by 58 percent . Says neither infinity nor abbvie have future financial obligations to other party . Exploring strategic options for program that could enable submission of global regulatory applications, commercialization for duvelisib . Says will not proceed with phase 1b/2 study of duvelisib in combination with venetoclax . Says ipi-549 is only investigational pi3k-gamma inhibitor in clinical development . Continuing to focus on filing nda for duvelisib with u.s. Food and drug administration (fda) in q4 of 2016 . Plans to seek feedback on dynamo data from fda . Strategic decisions include closing bravura, a phase 3 study of duvelisib, contempo, a phase 1b/2 study of duvelisib . Also expects to report topline data from duo, predicated on results of an interim analysis, in q3 of 2016 .Infinity regains worldwide rights to duvelisib following mutual agreement with abbvie to end collaboration.  Full Article

Coherus BioSciences provides update on IPRs
Monday, 13 Jun 2016 02:04pm EDT 

Coherus BioSciences Inc : Received favorable decision from Patent Trial and Appeal Board related to dosing regimen for Abbvie's Humira (Adalimumab) .Coherus BioSciences provides update on IPRs.  Full Article

Abbvie reports 17.93 pct passive stake in Reata as of May 25 - SEC filing
Monday, 6 Jun 2016 05:25pm EDT 

Reata Pharmaceuticals Inc :Abbvie Inc reports 17.93 pct passive stake in Reata Pharmaceuticals Inc as of May 25, 2016 - SEC filing.  Full Article

AbbVie says entered share repurchase agreement with JPMorganChase
Thursday, 2 Jun 2016 12:16pm EDT 

Abbvie Inc : On June 1, entered into an accelerated share repurchase agreement with JPMorganChase to repurchase $3.8 billion of stock .AbbVie Inc says JPMorgan is expected to make an initial delivery of about 54.4 million shares of AbbVie's common stock on June 2, 2016.  Full Article

Moody's downgrades AbbVie to Baa2; stable outlook
Wednesday, 1 Jun 2016 06:08pm EDT 

Moody's: Moody's downgrades AbbVie to Baa2; stable outlook . Baa2 rating reflects its large scale with a revenues of about $23 billion, its high margins and its strong cash flow . In light of continuing revenue concentration in Humira, this degree of financial leverage positions AbbVie at the Baa2 rating level .Rating outlook is stable, reflecting expectations for good organic growth offset by product concentration risk.  Full Article

BRIEF-Abbvie receives U.S. FDA approval of once-daily VIEKIRA XR

* Abbvie receives U.S. FDA approval of once-daily VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the treatment of genotype 1 chronic Hepatitis C