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GlaxoSmithKline PLC (GSK)

GSK on New York Consolidated

35.06USD
22 Nov 2017
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$0.25 (+0.72%)
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Latest Key Developments (Source: Significant Developments)

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

GlaxoSmithkline receives European marketing authorisation for self-injectable formulation of Benlysta for treatment of systemic lupus erythematosus
Monday, 13 Nov 2017 04:06am EST 

Nov 13 (Reuters) - GLAXOSMITHKLINE PLC ::RECEIVES EUROPEAN MARKETING AUTHORISATION FOR SELF-INJECTABLE FORMULATION OF BENLYSTA FOR TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS​.‍APPROVAL IS FOR A SINGLE-DOSE PREFILLED SYRINGE AND A SINGLE-DOSE PREFILLED PEN , ADMINISTERED AS A ONCE WEEKLY INJECTION OF 200MG​.  Full Article

Glaxosmithkline says ‍results of first study assessing levels of organ damage in patients with active SLE
Wednesday, 8 Nov 2017 12:33pm EST 

Nov 8 (Reuters) - GLAXOSMITHKLINE PLC ::SAYS ‍RESULTS OF FIRST STUDY ASSESSING LEVELS OF ORGAN DAMAGE IN PATIENTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) TREATED WITH BENLYSTA (BELIMUMAB) PLUS STANDARD OF CARE (SOC) VERSUS SOC ALON​E.‍PATIENTS WITH SLE ARE AT RISK OF IRREVERSIBLE ORGAN DAMAGE, WHICH CAN ACCRUE OVER TIME AND IS ASSOCIATED WITH INCREASED RISK OF DEATH​.‍SAFETY PROFILE OBSERVED IN BLISS-76 LONG-TERM EXTENSION STUDY WAS CONSISTENT WITH THAT OBSERVED IN OVERALL BLISS CLINICAL TRIAL PROGRAMME FOR BELIMUMAB​.  Full Article

Glaxosmithkline says ‍Hal Barron appointed as chief scientific officer and president, research and development​
Wednesday, 8 Nov 2017 09:00am EST 

Nov 8 (Reuters) - Glaxosmithkline Plc :‍HAL BARRON HAS BEEN APPOINTED CHIEF SCIENTIFIC OFFICER AND PRESIDENT, RESEARCH AND DEVELOPMENT​.‍BARRON IS CURRENTLY PRESIDENT RESEARCH AND DEVELOPMENT AT CALICO​.‍BARRON WILL ASSUME HIS NEW ROLE AND JOIN BOARD ON 1 JANUARY 2018​.  Full Article

Glaxosmithkline says Patrick Vallance to leave as president, research and development
Wednesday, 8 Nov 2017 09:00am EST 

Nov 8 (Reuters) - Glaxosmithkline Plc :PATRICK VALLANCE, PRESIDENT, RESEARCH AND DEVELOPMENT, TO LEAVE CO TO BECOME UK GOVERNMENT'S CHIEF SCIENTIFIC ADVISER AND HEAD OF GOVERNMENT'S OFFICE FOR SCIENCE​.‍APPOINTED DR HAL BARRON AS CHIEF SCIENTIFIC OFFICER AND PRESIDENT, RESEARCH AND DEVELOPMENT, GSK; DR BARRON WILL JOIN GSK ON 1 JANUARY 2018.​.‍PATRICK WILL LEAVE GSK AT END OF MARCH 2018 TO TAKE UP HIS NEW ROLE​.  Full Article

INTERVIEW-GSK CEO says top R&D appointment underscores focus on improving pharma
Wednesday, 8 Nov 2017 08:43am EST 

Nov 8 (Reuters) - GlaxoSmithKline CEO Emma Walmsley tells Reuters::Hiring Barron underscores her "absolute, unequivocal prioritisation" on improving pharma business.Barron appointment "highly significant" and "exciting" given his expertise at Roche in oncology and specialty therapy areas.It will be up to Barron as new research and development head to decide where to place pharma pipeline bets.  Full Article

Glaxosmithkline says submission of supplemental biologics license application to US FDA
Tuesday, 7 Nov 2017 10:01am EST 

Nov 7 (Reuters) - GLAXOSMITHKLINE PLC ::‍US REGULATORY APPLICATION FOR MEPOLIZUMAB IN COPD​.‍ANNOUNCED SUBMISSION OF A SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION (SBLA) TO UNITED STATES FOOD AND DRUG ADMINISTRATIO​.‍SUBMISSION INCLUDES PHASE III DATA FROM PREVIOUSLY REPORTED 1,2 METREX AND METREO STUDIES.​.‍SEEKING APPROVAL OF MEPOLIZUMAB, AN INTERLEUKIN-5 (IL-5) ANTAGONIST.‍REGULATORY FILINGS IN OTHER COUNTRIES ARE PLANNED DURING COURSE OF 2017 AND 2018.​.  Full Article

GSK says BCMA receives FDA breakthrough therapy designation and orphan drug designation
Thursday, 2 Nov 2017 03:35am EDT 

Nov 2 (Reuters) - GLAXOSMITHKLINE PLC :BCMA RECEIVES FDA BREAKTHROUGH THERAPY DESIGNATION.‍INVESTIGATIONAL BCMA ANTIBODY-DRUG CONJUGATE RECEIVES BREAKTHROUGH THERAPY DESIGNATION FROM US FDA FOR RELAPSED AND REFRACTORY MULTIPLE MYELOMA​.‍GSK2857916 HAS ALSO RECEIVED ORPHAN DRUG DESIGNATION FROM EMA AND FDA FOR MULTIPLE MYELOMA​.  Full Article

U.S. FDA approves first two-drug HIV regimen in win for GSK

The U.S. Food and Drug Administration has approved the first two-drug regimen to treat HIV, the virus that causes AIDS, aimed at lessening the side effect burden of current treatments that combine three or four medicines.