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GlaxoSmithKline PLC (GSK.N)

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Latest Key Developments (Source: Significant Developments)

GSK Starts Phase 3 Study Of Rsv Maternal Candidate Vaccine
Monday, 23 Nov 2020 

Nov 23 (Reuters) - GlaxoSmithKline PLC ::GSK STARTS PHASE 3 STUDY OF RSV MATERNAL CANDIDATE VACCINE.GSK - PHASE 1/2 TRIAL DEMONSTRATED STRONG IMMUNOGENICITY OF VACCINE CANDIDATE.GSK - GRACE STUDY EVALUATES SAFETY OF CANDIDATE VACCINE FOR PREGNANT MOTHERS AND INFANTS, AND ITS EFFICACY IN INFANTS BORN TO VACCINATED MOTHERS.GSK- STUDY IS ESTIMATED TO END IN EARLY 2024, WITH INTERIM RESULTS EXPECTED BY SECOND HALF OF 2022.  Full Article

Viiv Healthcare Says CHMP Positive Opinion For Dispersible-Tablet Formulation Of Dolutegravir
Friday, 13 Nov 2020 

Nov 13 (Reuters) - ViiV Healthcare::CHMP POSITIVE OPINION FOR DISPERSIBLE-TABLET FORMULATION OF DOLUTEGRAVIR, TIVICAY, TREATMENT FOR CHILDREN LIVING WITH HIV IN EUROPE.  Full Article

Medicago, GSK Starts Phase 2/3 Trials Of Adjuvanted Covid-19 Vaccine
Thursday, 12 Nov 2020 

Nov 12 (Reuters) - GSK::MEDICAGO AND GSK ANNOUNCE START OF PHASE 2/3 CLINICAL TRIALS OF ADJUVANTED COVID-19 VACCINE CANDIDATE.GSK - PHASE 2/3 CLINICAL TRIALS OF THE PLANT-DERIVED VACCINE CANDIDATE FOR COVID-19 TO EVALUATE ITS EFFICACY, SAFETY, AND IMMUNOGENICITY.GSK - PHASE 3 PART OF CLINICAL TRIAL TO ENROL OVER 30,000 VOLUNTEERS WORLDWIDE.GSK - TRIAL TO BE CONDUCTED IN CANADA AND, UPON FDA ALLOWANCE, IN U.S., IN HEALTHY ADULTS AND ELDERLY ADULTS.GSK - STUDY TO CONFIRM FORMULATION, DOSING REGIMEN OF COVLP (2 DOSES OF 3.75 ΜG COVLP WITH CO'S PANDEMIC ADJUVANT GIVEN 21 DAYS APART).GSK - PHASE 3 PART OF STUDY WILL START BEFORE END OF 2020.GSK - EACH AGE GROUP WILL HAVE OVER 300 SUBJECTS RANDOMIZED 5:1 TO RECEIVE ADJUVANTED COVLP VACCINE: PLACEBO, WITH 2:1 STRATIFICATION IN OLDER ADULTS.  Full Article

Adaptive - Collaboration With Glaxosmithkline PLC To Use Its Clonoseq Assay To Assess Minimal Residual Disease In Gsk's Portfolio Of Hematology Products
Wednesday, 11 Nov 2020 

Nov 10 (Reuters) - Adaptive Biotechnologies Corp ::ADAPTIVE - COLLABORATION WITH GLAXOSMITHKLINE PLC TO USE ITS CLONOSEQ ASSAY TO ASSESS MINIMAL RESIDUAL DISEASE IN GSK'S PORTFOLIO OF HEMATOLOGY PRODUCTS.ADAPTIVE BIOTECHNOLOGIES - WILL RECEIVE UPFRONT AND POTENTIAL FUTURE REGULATORY MILESTONE PAYMENTS IN CERTAIN GEOGRAPHIES.ADAPTIVE BIOTECHNOLOGIES - SPECIFIC FINANCIAL TERMS OF AGREEMENT WILL NOT BE DISCLOSED.  Full Article

Medicago Announces Positive Phase 1 Results For Its COVID-19 Vaccine Candidate
Tuesday, 10 Nov 2020 

Nov 10 (Reuters) - :MEDICAGO ANNOUNCES POSITIVE PHASE 1 RESULTS FOR ITS COVID-19 VACCINE CANDIDATE.MEDICAGO - THERE WERE NO SEVERE ADVERSE EVENTS REPORTED IN STUDY; REACTOGENICITY EVENTS WERE GENERALLY MILD TO MODERATE & SHORT IN DURATION.MEDICAGO - SIGNIFICANT HUMORAL, CELL-MEDIATED IMMUNE RESPONSES OBSERVED WITH GSK'S PANDEMIC ADJUVANT TECHNOLOGY AND DYNAVAX’S CPG 1018.MEDICAGO - PLANS TO PROCEED WITH PHASE 2/3 CLINICAL TRIAL FOR COVID-19 VACCINE CANDIDATE, SUBJECT TO REGULATORY APPROVAL.MEDICAGO - TRIAL RESULTS SHOWED 100% OF SUBJECTS DEVELOPED PROMISING ANTIBODY RESPONSE AFTER TWO DOSES OF COVID-19 ADJUVANTED VACCINE CANDIDATE.MEDICAGO - BASED ON OVERALL DATA PROFILE, 3.75 MCG/DOSE WITH GSK’S PANDEMIC ADJUVANT WAS SELECTED FOR PHASE 2/3 CLINICAL TRIAL.MEDICAGO - ALL SUBJECTS IN GROUP WITH GSK’S PANDEMIC ADJUVANT DEVELOPED ANTI-SPIKE IGG ANTIBODIES AFTER SINGLE DOSE OF VACCINE.  Full Article

GSK Says Aims To Have Net Zero Impact On Climate And A Net Positive Impact On Nature By 2030
Tuesday, 3 Nov 2020 

Nov 3 (Reuters) - GlaxoSmithKline PLC ::GSK - GSK SETS NEW ENVIRONMENTAL GOALS OF NET ZERO IMPACT ON CLIMATE AND NET POSITIVE IMPACT ON NATURE BY 2030.GSK - GSK SETS NEW ENVIRONMENTAL GOALS OF NET ZERO IMPACT ON CLIMATE AND NET POSITIVE IMPACT ON NATURE BY 2030.GSK - AIMING TO HAVE A NET ZERO IMPACT ON CLIMATE AND A NET POSITIVE IMPACT ON NATURE BY 2030.GSK - COMPANY HAS SET NEW TARGETS ACROSS ITS DIFFERENT BUSINESSES.GLAXOSMITHKLINE PLC - GSK SETS NEW ENVIRONMENTAL GOALS.GSK - SETS NEW ENVIRONMENTAL GOALS OF NET ZERO IMPACT ON CLIMATE AND NET POSITIVE IMPACT ON NATURE BY 2030.GSK - AIMING TO HAVE A NET ZERO IMPACT ON CLIMATE AND A NET POSITIVE IMPACT ON NATURE BY 2030..GSK - NEW GOALS APPLY PRINCIPALLY TO GSK'S BIOPHARMA BUSINESS AND PORTFOLIO..GSK - COMPANY WILL ALIGN TO SCIENCE BASED TARGETS NETWORK APPROACH TO MEASURE ITS IMPACT ON NATURE.GSK - NEW GOALS APPLY PRINCIPALLY TO GSK'S BIOPHARMA BUSINESS AND PORTFOLIO.GSK - COMPANY'S CONSUMER HEALTHCARE BUSINESS WILL ALSO CONTRIBUTE TOWARDS THESE GOALS THROUGH DELIVERY OF ITS OWN TARGETS, WHILST IT IS PART OF GSK.  Full Article

AnaptysBio And GlaxoSmithKline Amend Strategic Immuno-Oncology Collaboration
Monday, 26 Oct 2020 

Oct 26 (Reuters) - AnaptysBio Inc ::ANAPTYSBIO AND GLAXOSMITHKLINE AMEND STRATEGIC IMMUNO-ONCOLOGY COLLABORATION.ANAPTYSBIO INC - GSK TO PAY ONE-TIME CASH PAYMENT OF $60MM TO ANAPTYSBIO WITHIN 30 DAYS.ANAPTYSBIO - GSK OBTAINS FREEDOM TO DEVELOP AND COMMERCIALIZE ZEJULA IN COMBINATION WITH THIRD PARTY MOLECULES.ANAPTYSBIO INC - GSK HAS AGREED TO INCREASE ROYALTIES DUE TO ANAPTYSBIO UPON NET SALES OF DOSTARLIMAB.  Full Article

GSK Says FDA Approves Nucala As Biologic Treatment For Hypereosinophilic Syndrome
Saturday, 26 Sep 2020 

Sept 25 (Reuters) - GlaxoSmithKline PLC ::GSK - FDA APPROVES NUCALA AS FIRST AND ONLY BIOLOGIC TREATMENT FOR HYPEREOSINOPHILIC SYNDROME (HES).  Full Article

ViiV Healthcare Announces FDA Approval Of An Expanded Indication For Dovato
Friday, 7 Aug 2020 

Aug 6 (Reuters) - GlaxoSmithKline PLC ::VIIV HEALTHCARE ANNOUNCES FDA APPROVAL OF AN EXPANDED INDICATION FOR DOVATO (DOLUTEGRAVIR/LAMIVUDINE), A COMPLETE TWO-DRUG REGIMEN FOR VIROLOGICALLY SUPPRESSED ADULTS WITH HIV-1.VIIV HEALTHCARE - VIROLOGICALLY SUPPRESSED ADULTS LIVING WITH HIV WHO MAY WANT TO SWITCH HIV TREATMENTS NOW HAVE A NEW OPTION WITH DOVATO.  Full Article

Sanofi, GSK Selected For Operation Warp Speed To Supply U.S. Government With 100 Mln Doses Of Covid-19 Vaccine​
Friday, 31 Jul 2020 

July 31 (Reuters) - Gsk ::SANOFI, GSK SELECTED FOR OPERATION WARP SPEED TO SUPPLY U.S. GOVERNMENT WITH 100 MILLION DOSES OF COVID-19 VACCINE​.U.S. GOVERNMENT TO PROVIDE UP TO $2.1 BILLION FOR DEVELOPMENT, CLINICAL TRIALS, MANUFACTURING, DELIVERY OF INITIAL 100 MILLION DOSES​ OF COVID-19 VACCINE.U.S. GOVERNMENT HAS FURTHER OPTION FOR SUPPLY OF ADDITIONAL 500 MILLION DOSES OF COVID-19 VACCINE LONGER TERM​.SANOFI LEADING CLINICAL DEVELOPMENT, REGISTRATION OF VACCINE; EXPECTS PHASE 1/2 STUDY TO START IN SEPT, PHASE 3 STUDY BY 2020-END.‍IF STUDY DATA ARE POSITIVE, COMPANIES CAN REQUEST U.S. REGULATORY APPROVAL IN H1 2021​.SANOFI, GSK SCALING UP MANUFACTURING OF ANTIGEN AND ADJUVANT TO PRODUCE UP TO ONE BILLION DOSES PER YEAR GLOBALLY.ONGOING DISCUSSIONS WITH EUROPEAN COMMISSION - WITH FRANCE, ITALY ON NEGOTIATION TEAM - AND OTHER GOVTS FOR GLOBAL ACCESS TO CORONAVIRUS VACCINE.  Full Article

Advanz Pharma draws private equity interest as creditors want out: sources

FRANKFURT/LONDON Drugmaker Advanz Pharma has drawn interest from private equity funds, including U.S. buyout fund Carlyle, as its creditors are scrambling to find a new owner following a debt restructuring deal last year, sources familiar with the matter said.