Key Developments: GlaxoSmithKline PLC (GSK)

GSK on New York Consolidated

17 Sep 2014
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Latest Key Developments (Source: Significant Developments)

Glaxosmithkline Plc and Theravance Inc announce Anoro (Umeclidinium/Vilanterol) gains marketing authorisation in Europe for the treatment of COPD
Thursday, 8 May 2014 11:12am EDT 

Glaxosmithkline Plc and Theravance Inc:Says the European Commission has granted marketing authorisation for Anoro (umeclidinium/vilanterol) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment to GSK of $15 mln following marketing authorisation for UMEC/VI by the European Commission.A further $15 mln payment to GSK will follow the launch of UMEC/VI in Europe.First launch is expected to take place in Europe in Q2-3 2014 with additional launches to follow thereafter.  Full Article

GI Dynamics Inc announces new EndoBarrier data from research with GlaxoSmithKline Plc
Monday, 5 May 2014 06:00pm EDT 

GI Dynamics Inc:Announced that new data from a study with GlaxoSmithKline Plc on EndoBarrier and its potential mechanism of action were presented at Digestive Disease Week 2014.During an oral presentation titled, “Duodenal-jejunal Bypass Liner Increases Fasting and Postprandial Serum Levels of Bile Acids in Patients with Severe Obesity.The increased level of bile acids we observed suggest that there may be a similar mechanism of action associated with EndoBarrier in the treatment of obesity and diabetes to that observed with gastric bypass.This mechanism may be the driver of the weight loss and glucose stabilization seen in patients treated with EndoBarrier.Researchers have proposed that increased postoperative levels of bile acids (BAs) may be tied to the effectiveness of a common type of gastric bypass surgery, Roux-en-Y gastric bypass.  Full Article

GlaxoSmithKline Plc receives approval for Incruse Ellipta in the US for the treatment of COPD
Wednesday, 30 Apr 2014 06:27pm EDT 

GlaxoSmithKline Plc:Says that the US Food and Drug Administration (FDA) has approved Incruse Ellipta (umeclidinium) as an anticholinergic indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).  Full Article

GlaxoSmithKline Plc reaffirms FY 2014 EPS guidance - Conference Call
Wednesday, 30 Apr 2014 01:00pm EDT 

GlaxoSmithKline Plc:Continue to expect to grow FY 2014 core EPS between 4-8 pct in constant-currency terms, and on an ex-divestment basis.Reported EPS of $112.20 in FY 2013.  Full Article

Glaxosmithkline plc declares first interim dividend
Wednesday, 30 Apr 2014 07:00am EDT 

Glaxosmithkline plc:Declares first interim dividend of 19 pence per share.Payable on July 10.  Full Article

Glaxosmithkline plc and Theravance Inc announces Anoro Ellipta now available in US for treatment of COPD
Monday, 28 Apr 2014 08:00am EDT 

Glaxosmithkline plc and Theravance Inc:Says Anoro Ellipta is now available to retail pharmacies in the US.Under the terms of its 2002 LABA collaboration agreement with GSK, Theravance agreed to make a milestone payment of $30 mln to GSK following the launch of Anoro Ellipta in the US.Anoro Ellipta (umeclidinium and vilanterol inhalation powder), the first once-daily product approved in the US that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of chronic obstructive pulmonary disease (COPD).  Full Article

GlaxoSmithKline Plc and Theravance Inc announce Phase III study of Fluticasone Furoate/Vilanterol in COPD commenced to support potential future filing in Japan
Tuesday, 22 Apr 2014 08:45am EDT 

GlaxoSmithKline Plc and Theravance Inc:Announces start of a Phase III efficacy and safety study of a combination treatment of the inhaled corticosteroid (ICS), fluticasone furoate and long-acting beta2 agonist (LABA), vilanterol (FF/VI).The study will evaluate the contribution of the ICS component on lung function, in patients with Chronic Obstructive Pulmonary Disease (COPD).Positive results from this study will help support a potential filing of FF/VI for the treatment of patients with COPD in Japan.The study is a 12 week, multicentre, randomised, double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25mcg once daily compared with VI 25mcg once daily, administered via the Ellipta inhaler.  Full Article

Glaxosmithkline Plc updates FY 2014 revenue guidance
Tuesday, 22 Apr 2014 02:01am EDT 

Glaxosmithkline Plc:Says proposed transaction with Novartis would increase GSK's fiscal 2014 revenues by 1.3 bln pounds to 26.9 bln pounds (on a 2013 pro forma basis) and fundamentally re-shape GSK's revenue base.Says these revenues would be split across Pharmaceuticals 62 pct., Consumer Healthcare 24 pct. and Vaccines 14 pct.  Full Article

GlaxoSmithKline Plc announces major three-part transaction with Novartis
Tuesday, 22 Apr 2014 02:01am EDT 

GlaxoSmithKline Plc:GSK and Novartis will create Consumer Healthcare Joint Venture to hold GSK's Consumer Healthcare business and Novartis' OTC Consumer Healthcare business.GSK will have controlling 63.5 pct equity interest in joint venture company with Novartis interest being 36.5 pct.GSK will acquire Novartis' global Vaccines business (excluding influenza vaccines) for initial cash consideration of $5.25 bln with subsequent potential milestone payments of up to $1.8 bln and ongoing royalties.GSK will divest marketed Oncology portfolio, related R&D activities and rights to AKT inhibitor and also grant of commercialisation partner rights for future oncology products to Novartis for aggregate cash consideration of $16 bln.GSK shareholders to receive 4 bln Pound capital return funded by net cash transaction proceeds and expected to be delivered via B share scheme.Transaction is expected to complete during the first half of 2015.  Full Article

GlaxoSmithKline Plc and Genmab A/S receive FDA approval for Arzerra(r) (ofatumumab) as first-line treatment in combination with Chlorambucil for Patients with Chronic Lymphocytic Leukemia
Thursday, 17 Apr 2014 03:52pm EDT 

GlaxoSmithKline Plc and Genmab A/S:U.S. Food and Drug Administration (FDA) has approved Supplemental Biologic License Application (sBLA) for use of Arzerra(r) (ofatumumab), a CD20-directed monoclonal antibody, in combination with chlorambucil for treatment of previously untreated patients with chronic lymphocytic leukemia (CLL).For whom fludarabine-based therapy is considered inappropriate.FDA approval of first-line indication is based on results from Phase III study (COMPLEMENT 1).Says which demonstrated statistically significant improvement in median progression-free survival (PFS) in patients who received combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and GSK.Arzerra is a registered trademark of the GSK group of companies.  Full Article

UPDATE 1-First UK volunteer gets experimental GSK Ebola shot in trial

LONDON, Sept 17 - The first volunteer in a fast-tracked British safety trial of an experimental Ebola vaccine made by GlaxoSmithKline received the injection on Wednesday, trial organisers said.

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