Key Developments: GlaxoSmithKline PLC (GSK)

GSK on New York Consolidated

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

Medidata Solutions Inc collaborates with GlaxoSmithKline Plc on mobile health initiative to test novel technology for clinical trial optimization
Monday, 17 Nov 2014 03:30am EST 

Medidata Solutions Inc:Says completion of a method development project conducted in partnership with GlaxoSmithKline plc (GSK) to evaluate the impact of unifying mobile health (mHealth) devices with cloud-based technologies in a clinical trial setting.Joint initiative assessed the capabilities of mHealth tools and evaluated how they could be used to enable a new model for clinical trial conduct that aligns site and patient needs with faster study execution and reduced costs.Collaborative project, which took place at GSK's Human Performance Lab, demonstrated that mHealth technologies have the power to comprehensively collect volumes of objective data that is reliable, secure and analysis-ready, and provides real-time, continuous insight into well being of patients.  Full Article

Galapagos says GSK2586184 will not be developed by Glaxosmithkline for oral administration in psoriasis
Thursday, 6 Nov 2014 01:30am EST 

Galapagos NV:GlaxoSmithKline (GSK) has informed Galapagos that GSK2586184, a selective JAK1 inhibitor licensed from Galapagos, will not be developed by GSK for oral administration in psoriasis.Decision due to the overall risk/benefit profile, including a drug-drug statin interaction liability.GSK is evaluating other indications for development of GSK2586184.GSK has disclosed on its website phase 2 psoriasis study results with GSK2856184.Results show higher efficacy than those published for apremilast, a recently approved oral medicine for psoriasis and psoriatic arthritis.  Full Article

Glaxosmithkline Plc reaffirms FY 2014 EPS guidance - Conference call
Wednesday, 22 Oct 2014 10:00am EDT 

Glaxosmithkline Plc:Says that it continue to expect FY 2014 core EPS to be broadly similar to FY 2013 on CER basis ex divestments.Reported EPS of $3.51 in FY 2013.  Full Article

Glaxosmithkline PLC declares third interim dividend
Wednesday, 22 Oct 2014 07:00am EDT 

Glaxosmithkline PLC:Declares third interim dividend of 19 pence per share.Equivalent interim dividend receivable by ADR holders is 61.3016 cents per ADS based on an exchange rate of £1/$1.6132.One ADS represents two ordinary shares.Says ex-dividend date will be Nov. 6.Says record date on Nov. 7.Says payment date on Jan. 8, 2015.  Full Article

Aspen Pharmacare Holdings Ltd to enter strategic collaboration with Glaxosmithkline in Japan
Thursday, 9 Oct 2014 01:05am EDT 

Aspen Pharmacare Holdings Ltd:Says Aspen Global Inc, subsidiary entered into an agreement with GlaxoSmithKline (GSK).Whereby GSK will take an equity stake in Aspen’s newly established subsidiary in Japan named Aspen Japan K.K.In terms of this agreement Aspen will hold 75 pct equity share in Aspen Japan, while GSK will hold 25 pct share.It is intended that Aspen Japan will, where feasible, be conduct through which Group will conduct its commercial operations in Japan in strategic alliance with GSK.AGI will transfer marketing authorisations and grant perpetual distribution rights to Aspen Japan for all products currently being marketed and distributed on behalf of Aspen in Japan.GSK will transfer marketing authorisations and grant distribution rights to Aspen Japan for certain mature products in GSK’s portfolio.  Full Article

General Electric Co's Healthcare to collaborate with GlaxoSmithKline Plc on commercial oncology testing
Tuesday, 30 Sep 2014 08:00am EDT 

General Electric Co:Announces GE Healthcare inks into an agreement between its affiliate, Clarient Diagnostic Services Inc and GlaxoSmithKline.Collaboration aims to improve access to diagnostic testing for cancer patients by establishing network of clinical laboratories to identify genetic mutations associated with different tumour types.Collaboration will enable GE to develop broader laboratory and data analytics service that will enable better efficiency in healthcare market related to oncology precision medicine.Under terms of agreement with GSK, GE Healthcare, through its Clarient affiliate, will initially use clinical laboratory, pathology and genomics expertise, to certify laboratories and generate diagnostic data on metastatic melanoma patients.First Clarient certified laboratories to initiate this work, are expected to be operational in several countries in early 2015.  Full Article

Valneva and Glaxosmithkline celebrate site dedication of vaccine facility in Texas
Friday, 19 Sep 2014 01:30am EDT 

Valneva SE:Joins GlaxoSmithKline in celebrating site dedication of Texas A&M pandemic influenza vaccine facility in Texas.Says Texas vaccine site is on track for completion by end of 2015, to be followed by start-up phase in 2016.  Full Article

GlaxoSmithKline Plc 's ViiV Healthcare announces that Triumeq receives EU approval
Wednesday, 3 Sep 2014 08:22am EDT 

GlaxoSmithKline PLC:Announced that European Commission (EC) has granted marketing authorisation for ViiV Healthcare's Triumeq tablets.Says Triumeq tablets for treatment of HIV in adults and adolescents aged 12 years and older and weighing at least 40kg.Before initiating treatment with abacavir-containing products, screening for presence of genetic marker, HLA-B*5701 allele, should be performed in any HIV-infected patient, irrespective of racial origin.Abacavir should not be used in patients known to carry HLA-B*5701 allele.  Full Article

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


Exclusive: Can the blood of Ebola survivors create a cure?

CHICAGO - For months, Vanderbilt University researcher Dr. James Crowe has been desperately seeking access to the blood of U.S. Ebola survivors, hoping to extract the proteins that helped them overcome the deadly virus for use in new, potent drugs. | Video

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