Key Developments: GlaxoSmithKline PLC (GSK.L)

GSK.L on London Stock Exchange

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

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

European Medicines Agency's CHMP issues positive opinion on GlaxoSmithKline Plc and Pfizer Inc ViiV Healthcare's Triumeq single-tablet regimen
Friday, 27 Jun 2014 09:33am EDT 

GlaxoSmithKline Plc:ViiV Healthcare, global specialist HIV company established by GlaxoSmithKline and Pfizer, says committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) has issues positive opinion recommending marketing authorisation.Issues for Triumeq (dolutegravir/abacavir/lamivudine) for treatment of HIV infection in adults and adolescents aged 12 years and older and weighing at least 40kg.  Full Article

Ligand Pharmaceuticals Inc Partner Glaxosmithkline Plc announces results of phase 3 PETIT2 study of Eltrombopag in Pediatric Patients with Chronic Immune Thrombocytopenia
Friday, 13 Jun 2014 07:30am EDT 

Ligand Pharmaceuticals Inc:GlaxoSmithKline (GSK) plc present results from Phase 3 PETIT2 study evaluating efficacy of eltrombopag vs. placebo in pediatric patients with chronic immune (idiopathic) thrombocytopenic purpura (cITP).Eltrombopag marketed as Promacta in U.S. and as Revolade in Europe and other countries across world.Says Eltrombopag met its primary endpoint, achieving statistically significant improvement in platelet counts with almost 40 percent of patients treated with eltrombopag attaining consistent platelet response for 6 of 8 weeks compared to placebo (39.7 percent vs. 3.4 percent, respectively, p<0.001).PETIT2 study results were highlighted today as part of a Press Briefing and Oral Presentation at the European Hematology Association Annual Congress in Milan, Italy.GSk moving forward with planned regulatory submissions for a pediatric indication in cITP later this year.  Full Article

GlaxoSmithKline Plc and Theravance Inc announces positive results from two phase III studies
Wednesday, 11 Jun 2014 07:30am EDT 

GlaxoSmithKline Plc and Theravance Inc:Positive results from two phase III studies, which showed that patients with chronic obstructive pulmonary disease (COPD) who received the anticholinergic, Incruse(tm) Ellipta (umeclidinium (UMEC) 62.5mcg), or umeclidinium 125mcg (an unlicensed dose).Says in addition to Relvar/Breo Ellipta an inhaled corticosteroid / long-acting beta2-agonist combination.Says achieved an additional improvement in lung function (FEV1) compared to patients receiving FF/VI plus placebo.Studies showed that for the primary endpoint of trough FEV1 at Day 85, the addition of UMEC 62.5mcg or UMEC 125mcg to FF/VI 100/25mcg resulted in a statistically improvement in lung function when compared with FF/VI 100/25mcg plus placebo in patients with COPD.  Full Article

Glaxosmithkline plc in $350 million cancer deal with biotech specialist-Business Standard
Monday, 2 Jun 2014 09:36am EDT 

Glaxosmithkline plc:Has agreed a $350-million deal with Adaptimmune to help develop and sell the biotechnology firm's cancer drugs, the companies said-Business Standard.Adaptimmune announced in a statement that it has entered a 'strategic cancer immunotherapy collaboration' with GSK to 'develop and commercialise novel cell-based therapies' in its lead clinical cancer programme.Adaptimmune would also receive royalties ranging from single to double digits on net sales.  Full Article

Genmab partner Glaxosmithkline to start additional pivotal studies with the subcutaneous formulation of ofatumumab
Friday, 30 May 2014 10:56am EDT 

Genmab A/S:Says its collaboration partner Glaxosmithkline Plc (GSK) has taken the decision to start additional pivotal studies with the subcutaneous formulation of ofatumumab.Phase III studies of subcutaneous ofatumumab in RRMS are expected to begin in 2015, following encouraging data from a Phase II study reported in Oct. 2013.In addition, GSK plans to file an IND for a potential pivotal study of subcutaneous ofatumumab in NMO, a rare autoimmune disorder which affects the optic nerve and spinal cord, during the year.  Full Article

GlaxoSmithKline Plc faces UK's SFO
Wednesday, 28 May 2014 02:00am EDT 

GlaxoSmithKline Plc:Has been informed by the UK's Serious Fraud Office (SFO) that it has opened a formal criminal investigation into the group's commercial practices.  Full Article

Glaxosmithkline Plc and Genmab A/S Receive CHMP Positive Opinion for Arzerra in combination with Chlorambucil or Bendamustine
Friday, 23 May 2014 09:22am EDT 

Glaxosmithkline Plc and Genmab A/S:Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) has issued positive opinion recommending variation to terms of marketing authorization.Says for Arzerra for new indication 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.  Full Article

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China hands drugmaker GSK record $489 million fine for paying bribes

SHANGHAI/LONDON - China fined GlaxoSmithKline Plc a record 3 billion yuan ($489 million) on Friday for paying bribes to doctors to use its drugs, underlining the risks of doing business there while also ending a damaging chapter for the British drugmaker.

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