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GlaxoSmithKline PLC (GSK.N)

GSK.N on New York Stock Exchange

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22 Sep 2017
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Latest Key Developments (Source: Significant Developments)

Theravance Biopharma highlights positive results from impact study of Trelegy Ellipta
Wednesday, 20 Sep 2017 04:05pm EDT 

Sept 20 (Reuters) - Theravance Biopharma Inc :Theravance Biopharma highlights positive headline results from impact study of Trelegy Ellipta announced by Glaxosmithkline and Innoviva.Theravance Biopharma Inc - ‍Single inhaler triple therapy met study primary endpoint​.Theravance Biopharma Inc - Theravance Biopharma is entitled to receive an 85% economic interest in royalties paid by GSK on worldwide net sales.Theravance Biopharma Inc - Is not responsible for any costs related to Trelegy Ellipta.  Full Article

GlaxoSmithkline and Innoviva announces positive impact results for Trelegy in COPD
Wednesday, 20 Sep 2017 02:00am EDT 

Sept 20 (Reuters) - GLAXOSMITHKLINE PLC ::POSITIVE IMPACT RESULTS FOR TRELEGY IN COPD.CO, INNOVIVA REPORT POSITIVE HEADLINE RESULTS FROM STUDY SHOWING SINGLE INHALER TRIPLE THERAPY TRELEGY ELLIPTA REDUCED COPD EXACERBATIONS.GLOBAL REGULATORY FILINGS WITH IMPACT STUDY ARE EXPECTED TO COMMENCE IN Q2 OF 2018.  Full Article

Theravance Biopharma highlights approval of trelegy ellipta for treatment of appropriate patients with COPD in the U.S.
Tuesday, 19 Sep 2017 08:30am EDT 

Sept 19 (Reuters) - Theravance Biopharma Inc :Theravance Biopharma highlights approval of trelegy ellipta (closed triple) as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US.Theravance Biopharma Inc - ‍Theravance Biopharma is entitled to receive an 85% economic interest in royalties paid by GSK on worldwide net sales​.Theravance Biopharma Inc - ‍Theravance Biopharma is not responsible for any costs related to trelegy ellipta​.  Full Article

GSK gets EU greenlight for self-injectable version of lupus drug
Friday, 15 Sep 2017 07:09am EDT 

Sept 15 (Reuters) - GLAXOSMITHKLINE PLC ::GSK RECEIVES CHMP POSITIVE OPINION FOR SELF-INJECTABLE FORMULATION OF BENLYSTA FOR SYSTEMIC LUPUS ERYTHEMATOSUS.‍POSITIVE OPINION WAS BASED ON RESULTS FROM BLISS-SC PHASE III PIVOTAL STUDY OF MORE THAN 800 PATIENTS WITH ACTIVE SLE​.‍A FINAL DECISION ON APPROVAL WILL BE MADE BY EUROPEAN COMMISSION, WHICH IS ANTICIPATED IN NEXT TWO TO THREE MONTHS.‍FURTHER REGULATORY SUBMISSIONS ARE UNDER REVIEW OR PLANNED IN OTHER COUNTRIES DURING COURSE OF 2017​​.  Full Article

GlaxoSmithKline says Trelegy Ellipta once-daily single inhaler triple therapy receives positive opinion from CHMP in Europe
Friday, 15 Sep 2017 02:00am EDT 

Sept 15 (Reuters) - GLAXOSMITHKLINE PLC ::TRELEGY ELLIPTA ONCE-DAILY SINGLE INHALER TRIPLE THERAPY RECEIVES POSITIVE OPINION FROM THE CHMP IN EUROPE FOR APPROPRIATE PATIENTS WITH COPD.TRELEGY ELLIPTA ONCE-DAILY SINGLE INHALER TRIPLE THERAPY RECEIVES POSITIVE OPINION FROM CHMP IN EUROPE FOR APPROPRIATE PATIENTS WITH COPD​.TRELEGY ELLIPTA ONCE-DAILY SINGLE INHALER TRIPLE THERAPY RECEIVES POSITIVE OPINION FROM THE CHMP IN EUROPE FOR APPROPRIATE PATIENTS WITH COPD.  Full Article

GlaxoSmithKline announces unanimous FDA approval for Shingrix in over 50s
Thursday, 14 Sep 2017 02:00am EDT 

Sept 14 (Reuters) - GLAXOSMITHKLINE PLC ::UNANIMOUS FDA APPROVAL FOR SHINGRIX IN OVER 50S.FDA ADVISORY COMMITTEE VOTES UNANIMOUSLY FOR SHINGRIX (HZ/SU) IN US FOR PREVENTION OF HERPES ZOSTER (SHINGLES) IN ADULTS AGES 50 AND OVER​.  Full Article

AbCellera Biologics launches antibody discovery collaboration with GSK
Tuesday, 12 Sep 2017 06:00am EDT 

Sept 12 (Reuters) - AbCellera Biologics Inc::ABCELLERA LAUNCHES ANTIBODY DISCOVERY COLLABORATION WITH GSK.SAYS WILL APPLY ITS SINGLE-CELL ANTIBODY SCREENING PLATFORM TO IDENTIFY ANTIBODIES AGAINST AN UNDISCLOSED MEMBRANE PROTEIN TARGET.FINANCIAL TERMS OF AGREEMENT WERE NOT DISCLOSED.  Full Article

GlaxoSmithKline announces mepolizumab phase III results in patients with COPD
Tuesday, 12 Sep 2017 03:57am EDT 

Sept 12 (Reuters) - GlaxoSmithKline Plc :ANNOUNCES PHASE III RESULTS PUBLISHED IN NEJM OF MEPOLIZUMAB IN PATIENTS WITH EOSINOPHILIC COPD AT RISK OF EXACERBATIONS.REGULATORY FILINGS PLANNED FOR 2017.REDUCTION IN FREQUENCY OF EXACERBATIONS OBSERVED IN METREX STUDY WAS STATISTICALLY SIGNIFICANT.‍FOR SECONDARY ENDPOINTS, STATISTICALLY SIGNIFICANT INCREASE IN TIME TO FIRST MODERATE AND SEVERE EXACERBATION IN METREX.NO NEW SAFETY CONCERNS TO KNOWN SAFETY PROFILE OF MEPOLIZUMAB WERE IDENTIFIED ON REVIEW OF DATA FROM THE STUDIES.  Full Article

Glaxosmithkline announce positive results from SLS lung study
Monday, 11 Sep 2017 03:14am EDT 

Sept 11 (Reuters) - GLAXOSMITHKLINE PLC ::GSK ANNOUNCE POSITIVE RESULTS FROM SLS LUNG STUDY.POSITIVE RESULTS FROM SALFORD LUNG STUDY (SLS) IN ASTHMA.STUDY WAS DESIGNED TO EXPLORE EFFECTIVENESS OF AN ASTHMA MEDICINE WHEN USED WITH MINIMAL INTERVENTION IN BROAD GROUP OF PEOPLE WITH ASTHMA.  Full Article

GSK exercises option over SPEAR T-cell therapy program targeting NY-ESO
Thursday, 7 Sep 2017 07:30am EDT 

Sept 7 (Reuters) - Adaptimmune Therapeutics Plc :Adaptimmune Therapeutics Plc - ‍GSK exercises option over SPEAR T-cell therapy program targeting NY-ESO​.Adaptimmune Therapeutics Plc - ‍Adaptimmune will receive up to £48 million ($61 million) from GSK over course of transition period​.Adaptimmune Therapeutics Plc - ‍anticipate transition of NY-ESO to GSK to be completed over coming months​.  Full Article

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FDA declines to approve J&J arthritis drug sirukumab

The U.S. Food and Drug Administration has declined to approve Johnson & Johnson's rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday.