Key Developments: GlaxoSmithKline PLC (GSK.L)

GSK.L on London Stock Exchange

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

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

GlaxoSmithKline Plc receives US approval for once-weekly type 2 diabetes treatment, Tanzeum
Tuesday, 15 Apr 2014 02:26pm EDT 

GlaxoSmithKline Plc:Announced that the US Food and Drug Administration (FDA) has approved Tanzeum (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes.Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.  Full Article

GlaxoSmithKline Plc faces bribery investigation in Poland-Business Standard
Sunday, 13 Apr 2014 10:43pm EDT 

GlaxoSmithKline Plc (GSK):According to BBC Panorama GSK Is facing a criminal investigation in Poland for allegedly bribing doctors to promote its asthma drug Seretide-Business Standard.The BBC reported that 11 doctors and a GSK regional manager have been charged over alleged corruption between 2010 and 2012.The investigation found evidence of inappropriate communication in contravention of GSK policy by a single employee. The employee concerned was reprimanded and disciplined as a result,' the drugmaker was quoted as saying.GSK could not be reached immediately outside regular working hours.According to the BBC, one doctor has admitted guilt and has been fined and given a suspended sentence.  Full Article

Agenus Inc updates on Glaxosmithkline PLC's MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Non-Small Cell Lung Cancer
Wednesday, 2 Apr 2014 02:00am EDT 

Glaxosmithkline PLC:Agenus Inc announced that GlaxoSmithKline's MAGRIT study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3 cancer immunotherapeutic trial in non-small cell lung cancer (NSCLC) patients, which contains Agenus'QS-21 Stimulon adjuvant, will be stopped.GSK announced that it will not be possible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment.  Full Article

Glaxosmithkline PLC presents data from phase III STABILITY study of darapladib in patients with chronic coronary
Sunday, 30 Mar 2014 07:00pm EDT 

Glaxosmithkline PLC:Presents data from the pivotal Phase III STABILITY study of darapladib.The global, double-blind, event-driven trial randomized 15,828 patients with chronic coronary heart disease (CHD) to receive 160mg of darapladib or placebo once daily on a background of standard of care.The primary endpoint was time to first occurrence of any major adverse cardiovascular event (MACE) comprising cardiovascular death, myocardial infarction (MI) and stroke.Secondary endpoints included coronary events comprising CHD death, urgent coronary revascularisation for myocardial ischemia, total coronary events comprising CHD death, MI, hospitalisation for unstable angina or any coronary revascularisation procedure.No difference was seen in the treatment groups in the time to first occurrence of MACE.During 3.7 years median follow-up, the primary endpoint of MACE occurred in 9.7 pct of patients in the darapladib group and 10.4 pct of patients in the placebo group, hazard ratio (HR) 0.94, 95 pct confidence interval (0.85 - 1.03), p=0.199.HRs for individual components were cardiovascular death 0.96 (0.83 - 1.11), MI 0.89 (0.77 - 1.03) and stroke 1.01 (0.81 - 1.27).The safety profile was well-characterised in this large outcome study.The study didn not meet its primary endpoint, the effects of darapladib on the reduction of coronary events are of potential interest.  Full Article

Glaxosmithkline Plc's Consumer Healthcare recalls alli
Thursday, 27 Mar 2014 09:00am EDT 

Glaxosmithkline Plc:Says GlaxoSmithKline Consumer Healthcare is voluntarily recalling all alli weight loss products from U.S. and Puerto Rico retailers.As the company believes that some packages of the product were tampered with and may contain product that is not authentic alli.  Full Article

GlaxoSmithKline Plc receives European authorisation for once-weekly type 2 diabetes treatment, Eperzan (albiglutide)
Wednesday, 26 Mar 2014 09:07am EDT 

GlaxoSmithKline Plc:European Commission granted marketing authorisation for once-weekly diabetes treatment Eperzan.Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults, to improve glucose control.  Full Article

Glaxosmithkline Plc's MAGRITi trial does not meet first co-primary endpoints
Thursday, 20 Mar 2014 03:00am EDT 

Glaxosmithkline Plc:Says an analysis of the MAGRITi trial, a Phase III trial of its MAGE-A3 cancer immunotherapeuticii in non-small cell lung cancer (NSCLC) patients, showed that the trial did not meet its first or second co-primary endpoint as it did not significantly extend disease-free survival (DFSiii).When compared to placebo in either the overall MAGE-A3 positive population (first co-primary endpoint) or in those MAGE-A3-positive patients who did not receive chemotherapy (second co-primary endpoint).  Full Article

Theravance Inc and GlaxoSmithKline Plc announces positive results from studies comparing ANORO ELLIPTA With SERETIDE DISKUS and ADVAIR DISKUS in Patients With COPD
Friday, 14 Mar 2014 08:00am EDT 

Theravance Inc and GlaxoSmithKline plc:Positive results from three phase III studies.Two studies comparing efficacy and safety of combination anticholinergic / long-acting beta2-adrenergic agonist, Anoro Ellipta with inhaled corticosteroid / long-acting beta2-adrenergic agonist combination, Advair Diskus and third comparing efficacy.Safety of Anoro Ellipta with Seretide Diskus 'FSC 500/50' in patients with chronic obstructive pulmonary disease (COPD) and no history of moderate to severe COPD exacerbations in the last year.In each of studies UMEC/VI achieved statistically improvement in lung function, measured as weighted mean forced expiratory volume in one second (wm FEV1) over 0-24 hours at the end of 12 week study (day 84), compared to either dose of FSC.  Full Article

GlaxoSmithKline Plc receives positive CHMP opinion for Incruse for the treatment of COPD
Friday, 21 Feb 2014 02:00am EST 

GlaxoSmithKline Plc:European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for umeclidinium under the proposed brand name Incruse.Says Incruse as a once-daily, maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease.Says umeclidinium is an investigational long-acting muscarinic antagonist (LAMA).Says the proposed strength is 55mcg inhalation powder contained in the Ellipta.  Full Article

AbbVie urges U.S. court to avoid gay rights issue in HIV drug case

- An Abbott Laboratories spinoff urged a federal appeals court to revisit a ruling in a case against GlaxoSmithKline Plc, but without disturbing landmark constitutional protections for gays and lesbians.

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