Key Developments: GlaxoSmithKline PLC (GSK)

GSK on New York Consolidated

30 Jan 2015
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Latest Key Developments (Source: Significant Developments)

Glaxosmithkline plc receives FDA approval of an additional Promacta indication for use in patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy
Tuesday, 26 Aug 2014 03:53pm EDT 

Glaxosmithkline plc:Announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for the once-daily use of Promacta in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy.SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells, and platelets.2Eltrombopag.Promacta gained Breakthrough Therapy designation status from the FDA in Jan. 2014 and Priority Review in April 2014.  Full Article

GlaxoSmithKline Plc 's ViiV Healthcare announces US FDA approved Triumeq
Tuesday, 26 Aug 2014 02:19am EDT 

ViiV Healthcare:Announced that US Food and Drug Administration (FDA) has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for treatment of HIV-1 infection.1.Says Triumeq is ViiV Healthcare's first dolutegravir-based fixed-dose combination, offering many people living with HIV option of single-pill regimen, combines integrase strand transfer inhibitor (INSTI) dolutegravir, with nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.ViiV Healthcare is a global specialist HIV company established in Nov. 2009 by GlaxoSmithKline and Pfizer.Says Triumeq alone is not recommended for use in patients with current or past history of resistance to any components of Triumeq.Triumeq alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected INSTI resistance because the dose of dolutegravir in Triumeq is insufficient in these populations.Before initiating treatment with abacavir-containing products, screening for presence of genetic marker, the HLA-B*5701 allele, should be performed in any HIV-infected patient, irrespective of racial origin.Products containing abacavir should not be used in patients known to carry the HLA-B*5701 allele .1.  Full Article

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

EU mergers and takeovers (Jan 28)

BRUSSELS, Jan 28 - The following are mergers under review by the European Commission and a brief guide to the EU merger process:

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