Key Developments: GlaxoSmithKline PLC (GSK)

GSK on New York Consolidated

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30 Oct 2014
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Latest Key Developments (Source: Significant Developments)

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

Glaxosmithkline Plc darapladib phase III solid study results
Tuesday, 13 May 2014 02:00am EDT 

Glaxosmithkline Plc:Announced headline results from its second phase III study with darapladib, SOLID-TIMI 52, evaluating efficacy of its investigational Lp-PLA2 inhibitor in adults following an acute coronary syndrome.In study, darapladib did not achieve primary endpoint of reduction of major coronary events versus placebo when added to standard of care.Overall safety profile for darapladib showed no major safety concerns and was generally consistent with safety data seen in previously reported phase III study, STABILITY.Further analysis of data is ongoing, Darapladib is not approved for use anywhere in world.Acute coronary syndrome is term used to describe situations or events , including heart attack, where there is sudden reduction of blood flow to heart.Initial presentation by patient with acute coronary syndrome results in a diagnosis of coronary heart disease.Primary endpoint measure in SOLID-TIMI 52 study was time to first occurrence of any event from composite of coronary heart disease death, myocardial infarction (heart attack) and urgent coronary revascularisation for myocardial ischemia.  Full Article

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

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Swiss test GSK Ebola vaccine in some volunteers going to Africa

GENEVA - Switzerland's drug regulator said on Tuesday it had approved the testing of an experimental Ebola vaccine from GlaxoSmithKline on healthy volunteers, some of whom will be traveling to West Africa as medical staff.

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