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GlaxoSmithKline PLC (GSK.F)

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23 Mar 2017
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Latest Key Developments (Source: Significant Developments)

GSK announces U.S. regulatory submission seeking expanded indication for Fluarix Quadrivalent for infants 6 months and older
Wednesday, 15 Mar 2017 11:13am EDT 

Glaxosmithkline Plc :GSK announces US regulatory submission seeking expanded indication for Fluarix Quadrivalent (Influenza vaccine) for infants 6 months and older.  Full Article

GlaxoSmithKline says for results positive in asthma study
Thursday, 2 Mar 2017 05:02am EST 

GlaxoSmithKline Plc : Feb. 23 2017 positive results for Relvar Ellipta lung function study in patients with well-controlled asthma positive headline results from a non-inferiority lung function study read more . Positive headline results from a non-inferiority lung function study . Results demonstrated statistically significant differences in favour of ics/laba combinations to FP (p<0.001). . Incidences of on-treatment serious adverse events and adverse events of special interest were consistent with known safety profile of ff/vi . Intends to submit this data to European Medicines Agency (EMA) . Gsk - study showed well-controlled asthma patients able to switch to once-daily relvar ellipta combination without compromising lung function .Gsk now intends to submit this data to european medicines agency.  Full Article

Aspen completes acquisition of a portfolio of anaesthetics with GlaxoSmithKline
Wednesday, 1 Mar 2017 02:00am EST 

Aspen Pharmacare Holdings:Aspen Holdings is pleased to announce that this transaction completed.  Full Article

GSK reports positive results in study for controlled asthma
Thursday, 23 Feb 2017 04:46am EST 

GlaxoSmithKline Plc : Positive results for Relvar Ellipta lung function study in patients with well-controlled asthma . Patients randomised to FF/VI taken once-daily maintained lung function versus those randomised to twice-daily FP/SAL, meeting study's primary endpoint . GSK now intends to submit this data to European Medicines Agency (EMA) .Incidences of on-treatment serious adverse events and adverse events of special interest were consistent with known safety profile of FF/VI,.  Full Article

GSK announces positive final stage results for two-drug HIV treatment
Tuesday, 14 Feb 2017 02:00am EST 

GlaxoSmithKline Plc : VIIV phase III results dolutegravir & rilpivirine . Announces detailed positive phase III results for investigational two-drug regimen of dolutegravir and rilpivirine for HIV treatment . In sword studies, two-drug regimen showed comparable efficacy to three- or four-drug regimens in virologically suppressed patients . Headline results were announced in December 2016 .Use of dolutegravir and rilpivirine as a two-drug regimen for hiv-1 maintenance therapy is investigational and not approved anywhere in world.  Full Article

ViiV Healthcare announces positive phase III results for two-drug regimen of Dolutegravir and Rilpivirine
Monday, 13 Feb 2017 06:55pm EST 

: ViiV Healthcare announces detailed positive phase III results for investigational two-drug regimen of dolutegravir and rilpivirine for HIV treatment . ViiV Healthcare - in SWORD studies, two-drug regimen showed comparable efficacy to three- or four-drug regimens in virologically suppressed patients . ViiV Healthcare - planning regulatory submissions for two-drug regimen as a single tablet in 2017 Further company coverage: [GSK.L] ((Bangalore.newsroom@thomsonreuters.com;)).  Full Article

New GSK CEO likely to give strategy update in H2 2017
Wednesday, 8 Feb 2017 07:45am EST 

Outgoing GlaxoSmithKline CEO Andrew Witty told reporters: 2017 outlook "very much" in line with market consensus . Lot of common ground with Trump on FDA regulatory reform but need to ensure safety . Accelerated drug approvals would give room for lowering drug prices . Shame if EMA moves from London because will cause disruption . Would be wise for UK to get significant mutual recognition with EMA on drug approvals . New CEO Emma Walmsley likely to update investors on strategy in H2 2017 Further company coverage: [GSK.L] (Reporting by UK bureau) ((uk.online@reuters.com;)).  Full Article

GSK says launched flonase sensimist allergy relief nationwide
Wednesday, 8 Feb 2017 07:00am EST 

GlaxoSmithKline PLC :GSK Consumer Healthcare - announced nationwide launch of flonase sensimist allergy relief.  Full Article

Pernix Therapeutics provides update on arbitration
Friday, 3 Feb 2017 08:00am EST 

Pernix Therapeutics Holdings Inc : Pernix therapeutics provides update on arbitration . Pernix therapeutics - pernix and gsk had been in arbitration regarding claims related to treximet asset purchase agreement and supply agreement . Is reviewing opinions, including amount of interest, and intends to work with gsk to conclude matter . Tribunal also denied pernix's claim that gsk breached its obligations under supply agreement . Pernix therapeutics - on jan 31, , arbitration tribunal issued opinions in favor of gsk, awarding it damages, fees in amount of about $35 million, plus interes .Pernix therapeutics holdings - pernix has already paid to gsk, or into an escrow account, an aggregate of $16.5 million, which will offset total award.  Full Article

EMA recommends approval of two biosimilars from Amgen
Friday, 27 Jan 2017 07:21am EST 

European Medicines Agency : EU Medicines Agency recommendations for January 2017 . EU Medicines Agency recommends approval of Amgen's Amgevita and Solymbic, both containing adalimumab . EU Medicines Agency recommends approval of Tadalafil Lilly for treatment of erectile dysfunction and signs, symptoms of benign prostatic hyperplasia . EU Medicines Agency's CHMP offers positive opinion for Rolufta for the treatment of chronic obstructive pulmonary disease .EU Medicines Agency - Jylamvo (methotrexate) received a positive opinion for the treatment of rheumatological disorders and psoriasis, and for maintenance treatment of ALL.  Full Article

More From Around the Web

BRIEF-GSK announces U.S. regulatory submission seeking expanded indication for Fluarix Quadrivalent for infants 6 months and older

* GSK announces US regulatory submission seeking expanded indication for Fluarix Quadrivalent (Influenza vaccine) for infants 6 months and older Source text for Eikon: Further company coverage: