Edition:
United States

GlaxoSmithKline PLC (GSK.L)

GSK.L on London Stock Exchange

1,486.00GBp
12:06pm EDT
Change (% chg)

22.40 (+1.53%)
Prev Close
1,463.60
Open
1,467.40
Day's High
1,487.20
Day's Low
1,463.00
Volume
7,993,303
Avg. Vol
7,686,322
52-wk High
1,634.48
52-wk Low
1,235.20

Latest Key Developments (Source: Significant Developments)

EMA's PRAC Issues Precautionary Advice On HIV Medicine Dolutegravir
Friday, 5 Oct 2018 09:21am EDT 

Oct 5 (Reuters) - European Medicines Agency::EMA- PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE HAS RECOMMENDED RESTRICTING THE USE OF FLUOROQUINOLONE AND QUINOLONE ANTIBIOTICS.EMA SAYS PRAC CONFIRMS PRECAUTIONARY ADVICE ON HIV MEDICINE DOLUTEGRAVIR.EMA- RESTRICTION RECOMMENDED FOLLOWING REVIEW OF DISABLING, POTENTIALLY LONG-LASTING SIDE EFFECTS REPORTED WITH FLUOROQUINOLONE, QUINOLONE ANTIBIOTICS.EMA - SOME FLUOROQUINOLONE, QUINOLONE ANTIBIOTICS TO BE REMOVED FROM MARKET AS THEY WERE AUTHORISED FOR INFECTIONS THAT SHOULD NO LONGER BE TREATED WITH THEM.  Full Article

Orchard Rx Limited Files For U.S. IPO Of Up To $172.5 Million
Thursday, 4 Oct 2018 04:58pm EDT 

Oct 4 (Reuters) - Orchard Rx Limited ::ORCHARD RX LIMITED FILES FOR U.S. IPO OF UP TO $172.5 MILLION – SEC FILING.ORCHARD RX LIMITED SAYS IT INTENDS TO APPLY TO HAVE ITS ADS LISTED ON NASDAQ GLOBAL MARKET UNDER THE SYMBOL "ORTX".ORCHARD RX LIMITED SAYS J.P. MORGAN, GOLDMAN SACHS & CO. LLC, COWEN ARE AMONG UNDERWRITERS TO IPO.ORCHARD RX LIMITED SAYS WEDBUSH PACGROW IS AMONG UNDERWRITERS TO IPO.ORCHARD RX LIMITED SAYS PROPOSED IPO PRICE IS AN ESTIMATE SOLELY FOR CALCULATING SEC REGISTRATION FEE.ORCHARD RX LIMITED SAYS GSK BENEFICIAL OWNERSHIP OF 17.9 PERCENT BEFORE THE U.S. IPO.  Full Article

Hitachi Chemical Advanced Therapeutics Solutions Says Signed A Three-Year Clinical Manufacturing Agreement With GSK
Monday, 1 Oct 2018 07:15am EDT 

Oct 1 (Reuters) - GlaxoSmithKline PLC ::HITACHI CHEMICAL ADVANCED THERAPEUTICS SOLUTIONS SAYS SIGNED A THREE-YEAR CLINICAL MANUFACTURING AGREEMENT WITH GSK.HITACHI CHEMICAL ADVANCED THERAPEUTICS SAYS CO TO MANUFACTURE GSK'S SPEAR T-CELL RECEPTOR THERAPY TARGETING NY-ESO-1 FOR U.S., CANADIAN, EUROPEAN TRIALS.HITACHI CHEMICAL ADVANCED THERAPEUTICS SOLUTIONS SAYS SIGNED A THREE-YEAR CLINICAL MANUFACTURING AGREEMENT WITH GSK.  Full Article

Glaxosmithkline PLC Reports 11.7 Pct Stake In Principia Biopharma Inc
Wednesday, 26 Sep 2018 06:21am EDT 

Sept 26 (Reuters) - GlaxoSmithKline PLC ::GLAXOSMITHKLINE PLC REPORTS 11.7 PERCENT STAKE IN PRINCIPIA BIOPHARMA INC AS OF SEPT. 18 - SEC FILING.  Full Article

GSK Says CHMP Recommends Expansion Of Trelegy COPD Label
Friday, 21 Sep 2018 07:30am EDT 

Sept 21 (Reuters) - GlaxoSmithKline PLC ::GLAXOSMITHKLINE PLC - CHMP RECOMMENDS EXPANSION OF TRELEGY COPD LABEL.GLAXOSMITHKLINE PLC - EMA COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) HAS ISSUED A POSITIVE OPINION TODAY SUPPORTING USE OF TRELEGY ELLIPTA.  Full Article

GSK Announces New Analysis On Asthma Drug Efficacy
Monday, 10 Sep 2018 03:00am EDT 

Sept 10 (Reuters) - GlaxoSmithKline PLC ::NEW ANALYSIS ON EFFICACY OF ANTI-IL5 BIOLOGICS SEA.NUCALA DEMONSTRATED GREATER REDUCTION IN EXACERBATIONS AND IMPROVED ASTHMA CONTROL.MEPOLIZUMAB DEMONSTRATED SIGNIFICANTLY GREATER IMPROVEMENTS IN ASTHMA CONTROL AS ASSESSED BY ACQ SCORE VERSUS RESLIZUMAB, BENRALIZUMAB.  Full Article

GSK Receives Complete Response Letter From U.S. FDA For Use Of Mepolizumab
Friday, 7 Sep 2018 05:08pm EDT 

Sept 7 (Reuters) - :GSK - RECEIVES COMPLETE RESPONSE LETTER FROM US FDA FOR USE OF MEPOLIZUMAB IN COPD PATIENTS.SAYS CRL STATES THAT MORE CLINICAL DATA ARE REQUIRED TO SUPPORT AN APPROVAL.  Full Article

Glaxosmithkline Plans To Eliminate About 650 Positions In The U.S. - Spokeswoman
Wednesday, 5 Sep 2018 05:07pm EDT 

Sept 5 (Reuters) - :GLAXOSMITHKLINE PLANS TO ELIMINATE ABOUT 650 POSITIONS IN THE U.S. - SPOKESWOMAN.  Full Article

GlaxoSmithKline Says EU Approves Nucala In Severe Asthma In Children
Thursday, 30 Aug 2018 03:12am EDT 

Aug 30 (Reuters) - GlaxoSmithKline PLC ::EU APPROVE NUCALA IN SEVERE ASTHMA IN CHILDREN.EC GRANTED MARKETING AUTHORISATION FOR NUCALA AS ADD-ON TREATMENT FOR SEVERE REFRACTORY EOSINOPHILIC ASTHMA IN PAEDIATRIC PATIENTS.  Full Article

GSK sees positive headline results from VIIV HC Atlas study
Wednesday, 15 Aug 2018 02:00am EDT 

Aug 15 (Reuters) - GlaxoSmithKline PLC ::POSITIVE HEADLINE RESULTS FOR VIIV HC ATLAS STUDY.POSITIVE HEADLINE RESULTS FOR VIIV HC ATLAS STUDY.REPORTS POSITIVE 48-WEEK RESULTS FOR FIRST PIVOTAL, PHASE III STUDY FOR NOVEL, LONG-ACTING, INJECTABLE HIV-TREATMENT REGIMEN.FULL RESULTS FROM STUDY WILL BE PRESENTED AT AN UPCOMING SCIENTIFIC MEETING.  Full Article

Photo

Stada, buyout funds in race for Bristol-Myers' French business: sources

LONDON German generic drugmaker Stada is vying with a group of European buyout funds for control of Bristol-Myers Squibb's French over-the-counter drugs business, sources familiar with the matter told Reuters.