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GlaxoSmithKline PLC (GSK.L)

GSK.L on London Stock Exchange

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Latest Key Developments (Source: Significant Developments)

GSK seeks Japanese approval for shingles vaccine
Tuesday, 18 Apr 2017 04:16am EDT 

April 18 (Reuters) - GlaxoSmithKline Plc ::Gsk vaccine submission for shingles in japan.JV between GSK, Daiichi Sankyo submitted new drug application in Japan seeking approval for candidate shingles vaccine, shingrix.  Full Article

GSK makes changes to financial reporting; sees growth in emerging markets
Tuesday, 11 Apr 2017 07:02am EDT 

GlaxoSmithKline Plc : Change to financial reporting framework . As a result of its latest review, GSK will be making following change to its financial reporting from Q1 2017. . Core results will be renamed adjusted results and will include 'ordinary course' legal charges . From Q1 2017, only significant legal charges and expenses will be excluded in order to present adjusted results. . Change is not expected to affect group's previously announced guidance for 2017 or group's outlook for five-year period 2016-2020 . Target expectation of at least 6 bln stg of revenue/ year on a CER basis by 2020 from products launched since 2013 is now expected to be met up to 2 yrs earlier .Expects volume demand for its products to increase, particularly in emerging markets.  Full Article

GlaxoSmithKline files for debt shelf of up to $10 bln - SEC Filing
Monday, 3 Apr 2017 05:45pm EDT 

GlaxoSmithKline Plc : Files for debt shelf of up to $10 billion - SEC Filing .GlaxoSmithKline - The debt securities will be issued by co or through one of its finance subsidiaries.  Full Article

Mylan receives CRL for generic Advair Diskus ANDA
Wednesday, 29 Mar 2017 01:16pm 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
Wednesday, 29 Mar 2017 07:30am 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

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

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Teva's new asthma inhaler poses first competition for GSK's Advair

Teva Pharmaceutical Industries Ltd on Thursday launched an asthma inhaler that will be the first direct competition to GlaxoSmithKline's best-selling Advair.