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GlaxoSmithKline PLC (GSK)

GSK on New York Consolidated

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14 Dec 2017
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Latest Key Developments (Source: Significant Developments)

Glaxosmithkline Submits Regulatory Application For Single-Dose Tafenoquine For Treatment Of Plasmodium Vivax Malaria
Thursday, 14 Dec 2017 12:14am EST 

Dec 14 (Reuters) - Glaxosmithkline Plc ::SUBMITS REGULATORY APPLICATION FOR SINGLE-DOSE TAFENOQUINE FOR TREATMENT OF PLASMODIUM VIVAX MALARIA TO AUSTRALIA'S THERAPEUTIC GOODS ADMINISTRATION​.GSK PLANS TO PROGRESS REGULATORY FILINGS IN OTHER COUNTRIES IN 2018‍​.  Full Article

U.S. FDA Approves First Drug For Eosinophilic Granulomatosis With Polyangiitis
Tuesday, 12 Dec 2017 10:27am EST 

Dec 12 (Reuters) - U.S. Food and Drug Administration::SAYS EXPANDED APPROVED USE OF NUCALA (MEPOLIZUMAB) TO TREAT ADULT PATIENTS WITH EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS‍.SAYS GRANTED APPROVAL OF NUCALA TO GLAXOSMITHKLINE.  Full Article

Glaxosmithkline Says ‍New Data From Phase III Clinical Study Supports Safety And Efficacy
Wednesday, 6 Dec 2017 02:00am EST 

Dec 6 (Reuters) - Glaxosmithkline Plc ::‍NEW DATA FROM A PHASE III CLINICAL STUDY SUPPORTS SAFETY AND EFFICACY OF SHINGRIX IN PREVENTING SHINGLES​.ZOE-HSCT STUDY SUCCEEDED PRIMARY OBJECTIVE BY DEMONSTRATING AN EFFICACY OF 68.17% AGAINST SHINGLES IN SUBJECTS ABOVE 18 YEARS OF AGE​.  Full Article

ACCC Institutes Proceedings Against GSK, Novartis
Tuesday, 5 Dec 2017 05:39pm EST 

Dec 6 (Reuters) - Australian Competition and Consumer Commission:INSTITUTED PROCEEDINGS AGAINST GLAXOSMITHKLINE HEALTHCARE AUSTRALIA PTY LTD (GSK) AND NOVARTIS CONSUMER HEALTH AUSTRALASIA.PROCEEDINGS ALLEGING THEY MADE FALSE OR MISLEADING REPRESENTATIONS IN MARKETING OF VOLTAREN OSTEO GEL AND VOLTAREN EMULGEL PAIN RELIEF PRODUCTS.SEEKING DECLARATIONS, INJUNCTIONS, PECUNIARY PENALTIES, A PUBLICATION ORDER, THE IMPOSITION OF A COMPLIANCE PROGRAM AND COSTS.  Full Article

John Wood Group Wins Multi-Million Dollar Contract Supporting Glaxosmithkline In Germany​
Tuesday, 5 Dec 2017 02:00am EST 

Dec 5 (Reuters) - John Wood Group Plc ::WOOD WINS CONTRACT SUPPORTING GLAXOSMITHKLINE.‍WOOD WINS MULTI-MILLION DOLLAR CONTRACT SUPPORTING GLAXOSMITHKLINE IN GERMANY​.  Full Article

Glaxosmithkline says ViiV Healthcare starts Phase 3 HIV prevention study in women
Thursday, 30 Nov 2017 02:05am EST 

Nov 30 (Reuters) - GLAXOSMITHKLINE PLC ::‍VIIV STARTS PHASE 3 HIV PREVENTION STUDY IN WOMEN​.‍VIIV HEALTHCARE, CO OWNED BY GSK, WITH PFIZER INC. AND SHIONOGI LTD AS SHAREHOLDERS, TO START PHASE III STUDY FOR PREVENTION OF HIV INFECTION IN SEXUALLY ACTIVE WOMEN​.  Full Article

GSK says submits US application for malaria drug
Monday, 27 Nov 2017 11:02pm EST 

Nov 28 (Reuters) - GLAXOSMITHKLINE PLC ::‍SUBMITS US REGULATORY APPLICATION FOR SINGLE-DOSE TAFENOQUINE FOR PLASMODIUM VIVAX MALARIA​.GSK.L - ‍TAFENOQUINE IS NOT APPROVED FOR USE ANYWHERE IN WORLD; PLANS TO PROGRESS REGULATORY FILINGS IN OTHER COUNTRIES IN 2017 AND 2018​.  Full Article

U.S. FDA approves Juluca, a two-drug regimen for certain patients with HIV
Tuesday, 21 Nov 2017 02:01pm EST 

Nov 21 (Reuters) - U.S. Food and Drug Administration::Approved Juluca, a fixed-dose tablet containing dolutegravir and rilpivirine, to treat adults with HIV-1 infections ‍​.Granted approval of Juluca to ViiV Healthcare​.  Full Article

GlaxoSmithKline says European Commission grants marketing authorisation for Trelegy Ellipta
Thursday, 16 Nov 2017 02:00am EST 

Nov 16 (Reuters) - Glaxosmithkline Plc :TRELEGY ELLIPTA ONCE-DAILY SINGLE INHALER TRIPLE THERAPY GAINS MARKETING AUTHORISATION IN EUROPE FOR TREATMENT OF COPD​.  Full Article

Paulson & Co Inc dissolves share stake in Apple, Amazon and AIG
Tuesday, 14 Nov 2017 05:20pm EST 

Nov 14 (Reuters) - Paulson & Co Inc : :Paulson & Co Inc dissolves share stake in Apple Inc and Amazon.Com Inc - SEC filing.Paulson & Co Inc dissolves share stake in AIG - SEC filing.Paulson & Co Inc dissolves share stake in Glaxosmithkline Plc.Paulson & Co Inc dissolves share stake in Sanofi.Paulson & Co Inc cuts share stake in T-Mobile US Inc by 14.1 percent to 5.2 million shares.Paulson & Co Inc - Change in holdings are as of Sept 30, 2017 and compared with the previous quarter ended as of June 30, 2017.  Full Article

BRIEF-Glaxosmithkline Submits Regulatory Application For Single-Dose Tafenoquine For Treatment Of Plasmodium Vivax Malaria

* SUBMITS REGULATORY APPLICATION FOR SINGLE-DOSE TAFENOQUINE FOR TREATMENT OF PLASMODIUM VIVAX MALARIA TO AUSTRALIA'S THERAPEUTIC GOODS ADMINISTRATION​