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GlaxoSmithKline PLC (GSK)

GSK on New York Consolidated

42.73USD
29 Mar 2017
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Latest Key Developments (Source: Significant Developments)

Mylan receives CRL for generic Advair Diskus ANDA
1:16pm EDT 

Mylan NV : Mylan comments on generic Advair Diskus abbreviated new drug application . In conjunction with Mylan's GDUFA goal date, company received a complete response letter from FDA regarding its ANDA for generic Advair Diskus .Is in process of reviewing the response and will provide an update on its application as soon as practicable once it has completed its review.  Full Article

Mylan says no comment at this point on U.S. generic Advair application
7:30am EDT 

Mylan : Spokeswoman says company has no comment at this point on its U.S. FDA application for generic copy of GlaxoSmithKline's Advair . For more on this story see [nL5N1H6149] Further company coverage: [MYL.O] (Reporting by Ben Hirschler) ((uk.online@reuters.com;)).  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

More From Around the Web

FDA declines to approve Mylan's generic of GSK's Advair for now

Mylan NV said on Wednesday the U.S. Food and Drug Administration declined to approve its generic version of GlaxoSmithKline Plc's blockbuster Advair asthma treatment, but provided no details of the agency's concerns or how long the product might be delayed.