Key Developments: GlaxoSmithKline PLC (GSK)

GSK on New York Consolidated

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19 Dec 2014
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Latest Key Developments (Source: Significant Developments)

GlaxosmithKline Plc receives FDA approval for Arnuity Ellipta (fluticasone furoate) in the US for the treatment of asthma
Wednesday, 20 Aug 2014 03:33pm EDT 

GlaxosmithKline Plc:Announced that the FDA has approved Arnuity Ellipta, a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm.Approved doses are Arnuity Ellipta 100mcg and 200mcg.Arnuity Ellipta is administered once daily via the dry powder inhaler called Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio.  Full Article

Pernix Therapeutics acquires POZEN Inc and Glaxosmithkline Plc's U.S. rights for TREXIMET
Wednesday, 20 Aug 2014 08:00am EDT 

POZEN Inc:Says the acquisition of all of GlaxoSmithKline's (GSK) rights to Treximet ((reg))(sumatriptan / naproxen sodium) have been acquired by Pernix Therapeutics Holdings, Inc. (Pernix).GSK has assigned the Product Development and Commercialization Agreement between POZEN and GSK to Pernix, and POZEN and Pernix have amended the agreement to address rights of the parties and future development.Under the amended agreement, Pernix will continue certain of GSK's ongoing development activities and undertake certain new activities, for which POZEN will provide reasonable assistance.  Full Article

Glaxosmithkline and Genmab announce positive interim result for phase III study of Ofatumumab as maintenance therapy for relapsed CLL
Thursday, 31 Jul 2014 02:52pm EDT 

Glaxosmithkline plc:Says the company and Genmab A/S announced that an Independent Data Monitoring Committee (IDMC) interim analysis of a Phase III study, PROLONG (OMB 112517), reached the predefined significance level for efficacy (p<=0.001).Says the interim analysis demonstrated that treatment with ofatumumab (Arzerra(tm)) met the primary endpoint of improving progression free survival (PFS).Says the study evaluated ofatumumab maintenance therapy versus no further treatment (observation) in patients with relapsed chronic lymphocytic leukemia (CLL) who responded to treatment at relapse.Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and GSK.  Full Article

FDA approves Glaxosmithkline Plc's Flonase Allergy Relief for sale over-the-counter in The United States
Thursday, 24 Jul 2014 01:32pm EDT 

Glaxosmithkline plc:Announces that the U.S. Food and Drug Administration (FDA) has approved Flonase Allergy Relief.Flonase Allergy Relief containing the No. 1 prescribed allergy treatment ingredient1, as an over-the-counter (OTC) treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies.2.Flonase Allergy Relief is the first and only over-the-counter nasal spray indicated for relief of all nasal and eye-related allergy symptoms3,4including runny nose, sneezing, itchy nose5-7, nasal congestion8-11and itchy and watery eyes.  Full Article

Glaxosmithkline Plc lowers FY 2014 guidance - Conference call
Wednesday, 23 Jul 2014 09:00am EDT 

Glaxosmithkline Plc:Says that it is unlikely that the company will deliver sales growth for FY 2014.Expects FY 2014 core EPS on constant exchange rate basis to be broadly similar to last year.Reported revenue of $41.433 billion and EPS of $3.51 in FY 2013.  Full Article

GlaxoSmithKline Plc declares second interim dividend
Wednesday, 23 Jul 2014 07:00am EDT 

GlaxoSmithKline Plc:Declares second interim dividend of 19 pence per share (Q2 2013: 18 pence per share).Ex-dividend date will be Aug. 6.Record date on Aug 08.Payment date on Oct. 2.  Full Article

Theravance Inc and Glaxosmithkline plc announce initiation of Phase III programme
Wednesday, 16 Jul 2014 02:25am EDT 

Theravance Inc and GlaxoSmithKline plc:Says the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease (COPD).IMPACT is a pivotal phase III study to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid (ICS) a long-acting muscarinic antagonist (LAMA); and a long-acting beta2-adrenergic agonist (LABA) in patients with COPD.  Full Article

Genmab and Glaxosmithkline receive EU authorization for Arzerra
Thursday, 3 Jul 2014 09:15am EDT 

Genmab A/S:Announces together with Glaxosmithkline plc that European Commission (EC) has granted marketing authorization for new indication for use of Arzerra (ofatumumab), human monoclonal antibody against CD20.Authorization granted for Arzerra in combination with chlorambucil or bendamustine for treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.Ofatumumab is being developed under co-development and collaboration agreement between Genmab and GSK.  Full Article

GlaxoSmithKline Plc and Theravance Inc announces submission to US Regulatory Authorities for Fluticasone Furoate/Vilanterol in Asthma
Monday, 30 Jun 2014 08:07am EDT 

GlaxoSmithKline Plc and Theravance Inc:Announces submission of supplemental New Drug Application (sNDA) to US Food and Drug Administration (FDA).Says for fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist, vilanterol (FF/VI) as once-daily treatment for asthma in patients aged 12 years and older, with brand name of Breo Ellipta.SNDA is seeking approval for two dose regimens, 100/25mcg and 200/25mcg, administered once daily using the Ellipta dry powder inhaler.Filing is based upon data generated from the comprehensive clinical development programme for FF/VI in asthma.Says clinical development programme comprised 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients with asthma, including the Phase III efficacy and safety study of FF/VI reported in Dec. 2013.  Full Article

GlaxosmithKline Plc and Genmab announce top-line results from Phase III study of ofatumumab versus physicians' choice for bulky fludarabine-refractory CLL
Friday, 27 Jun 2014 02:27pm EDT 

GlaxosmithKline Plc:Says the company and Genmab A/S announced Phase III study of ofatumumab (Arzerra) versus physicians' choice in patients with bulky fludarabine-refractory chronic lymphocytic leukaemia (CLL) did not meet its primary endpoint of progression free survival.Says the median PFS, as assessed by the Independent Review Committee, was 5.36 months for ofatumumab and 3.61 months for physicians' choice (Hazard Ratio 0.79, p=0.267.Study (OMB114242) was conducted to meet the requirements from the EU Commission for the conditional approval of ofatumumab for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab.  Full Article

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GSK Ebola vaccine trial seen moving to wider phase in February

GENEVA - Trials of GlaxoSmithKline's experimental Ebola vaccine are likely to move to a second phase in February, later than previously suggested, after a meeting of national regulators said they needed more information.

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