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GlaxoSmithKline PLC (GSK.N)

GSK.N on New York Stock Exchange

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20 Oct 2017
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Latest Key Developments (Source: Significant Developments)

Glaxosmithkline says Shingrix approved in US
Friday, 20 Oct 2017 06:42pm EDT 

Oct 20 (Reuters) - GlaxoSmithKline Plc :Shingrix approved in the us for prevention of shingles in adults aged 50 and over‍​ ‍​.Pooled clinical trial for Shingrix showed greater than 90 percent efficacy across all age groups ‍​.Following this approval from FDA, and pending recommendation from ACIP, Shingrix will be available shortly‍​.  Full Article

Glaxosmithkline says ‍shingles vaccine approved in Canada
Friday, 13 Oct 2017 01:31pm EDT 

Oct 13 (Reuters) - Glaxosmithkline Plc ::‍SHINGRIX HAS BEEN APPROVED IN CANADA FOR PREVENTION OF SHINGLES (HERPES ZOSTER) IN PEOPLE AGED 50 YEARS OR OLDER​.‍APPROVAL IN CANADA WAS BASED ON PHASE III CLINICAL TRIAL PROGRAMME EVALUATING ITS EFFICACY, SAFETY AND IMMUNOGENICITY IN MORE THAN 37,000 PEOPLE​.  Full Article

Emergent Biosolutions completes acquisition of Raxibacumab from GSK​
Tuesday, 3 Oct 2017 07:00am EDT 

Oct 3 (Reuters) - Emergent Biosolutions Inc : :Emergent Biosolutions Inc - ‍transaction anticipated to be additive by approximately $9 million to revenue and neutral to GAAP net income for full year 2017​.Emergent Biosolutions - completed acquisition of Raxibacumab from GSK​.  Full Article

GlaxoSmithKline receives approval for Benlysta in Japan for treatment of systemic lupus erythematosus
Wednesday, 27 Sep 2017 03:14am EDT 

Sept 27 (Reuters) - Glaxosmithkline Plc :‍JAPANESE MHLW APPROVED BENLYSTA FOR TREATMENT OF ADULT PATIENTS WITH SLE WHO ARE INADEQUATE RESPONDERS TO EXISTING THERAPIES​.  Full Article

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

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GlaxoSmithKline adult shingles vaccine wins U.S. approval

The U.S. Food and Drug Administration approved GlaxoSmithKline's Shingrix shingles vaccine for use in adults aged 50 and over, a move widely expected after an advisory panel to the agency last month voted unanimously to recommend its approval, the company announced on Friday.