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GlaxoSmithKline PLC (GSK.L)

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Latest Key Developments (Source: Significant Developments)

GSK files EU submission for closed triple combination therapy for patients with COPD
Friday, 2 Dec 2016 10:12am EST 

Innoviva Inc - : GSK files regulatory submission in European union for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD . Regulatory submissions of closed triple therapy for COPD are anticipated in rest of world beginning in 2017 .EU regulatory submission comprises marketing authorisation application for maintenance treatment to relieve symptoms of adult patients with COPD.  Full Article

GSK applies for EU marketing nod for COPD drug cocktail
Friday, 2 Dec 2016 09:15am EST 

Glaxosmithkline Plc : Gsk files regulatory submission in european union for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD .Regulatory submissions of closed triple therapy for COPD are anticipated in rest of world beginning in 2017.  Full Article

GSK's lung drug gains approval in Japan
Friday, 2 Dec 2016 02:01am EST 

GlaxoSmithKline Plc : Relvar Ellipta approved in japan for COPD . Relvar Ellipta 100/25 mcg gains approval in Japan for use in patients with COPD . Japanese ministry of health, labour and welfare (MHLW) has approved Relvar Ellipta (Fluticasone Furoate / Vilanterol 100/25 mcg) .Relvar Ellipta has been approved in Japan for treatment of asthma since 2013 in two strengths - 100/25 mcg and 200/25 mcg.  Full Article

GSK receives FDA approval for expanded indication for flulaval® quadrivalent (influenza vaccine) for infants 6 months and older
Monday, 21 Nov 2016 08:28am EST 

Glaxosmithkline Plc :GSK receives FDA approval for expanded indication for flulaval® quadrivalent (influenza vaccine) for infants 6 months and older.  Full Article

GSK files regulatory submission in US for once-daily closed triple combination therapy ff/umec/vi for patients with COPD
Monday, 21 Nov 2016 07:00am EST 

Glaxosmithkline Plc :GSK files regulatory submission in us for once-daily closed triple combination therapy ff/umec/vi for patients with copd.  Full Article

GSK gets European nod for Boostrix vaccine label changes
Tuesday, 1 Nov 2016 09:06am EDT 

Glaxosmithkline Plc : Gsk receives european approval for updated Boostrix and Boostrix Polio label to benefit pregnant women Further company coverage: [GSK.L].  Full Article

GSK CEO says weak pound hasn't impacted company's UK pricing
Wednesday, 26 Oct 2016 07:15am EDT 

GlaxoSmithKline CEO Andrew Witty told reporters: CEO says change in sterling has not impacted pricing in UK, given large UK manufacturing base . CEO says U.S. net prices minus 2 percent year to date . CEO says sees continued pressure on U.S. pricing in long term . CEO says new respiratory products performing extremely strongly . CEO says seeing deceleration of parallel trade in medicines into UK, too early to call on parallel exports Further company coverage: [GSK.L] (Reporting by UK bureau) ((uk.online@reuters.com;)).  Full Article

GSK appoints Emma Walmsley as new CEO
Tuesday, 20 Sep 2016 02:00am EDT 

GlaxoSmithKline Plc : GSK appoints new CEO . Emma Walmsley, currently chief executive officer (CEO) of GSK's consumer healthcare division, is appointed GSK ceo designate .Emma will join GSK board of directors from Jan. 1 2017.  Full Article

Aspen Pharma to buy almost entire of GSK's anaesthetics portfolio
Monday, 12 Sep 2016 03:00am EDT 

Aspen Pharmacare Holdings Limited : Aspen announces signing of agreements with GSK . Signed an agreement with GSK whereby AGI will acquire a portfolio of anaesthetics globally with exception of certain territories . Aspen expects portfolio to generate revenue of approximately 70 mln stg in year ended Dec. 31 2016 . Will pay an initial amount of 180 mln stg and milestone payments of up to 100 mln stg . AGI and GSK have also signed a supply agreement whereby GSK will continue to supply products to AGI in medium term . AGI's upfront investment will be funded from debt facilities . Deal anticipated to complete during Q3 of Aspen's 2017 financial year . If GSK portfolio was owned for entire 2017 financial year, it would be expected to add approximately 75 cents per share to NHEPS of group . Net impact on NHEPS of acquisition of thrombolytic products and cancellation of SSA collaboration should not be material . Aspen unit and gsk have agreed to cancel rights of Pharmacare to collaborate in sub-Saharan business of GSK .GSK will pay pharmacare 45 mln stg as consideration for cancellation of SSA collaboration.  Full Article

GSK presents positive results from phase III FULFIL study
Tuesday, 6 Sep 2016 09:45am EDT 

GlaxoSmithKline Plc : Gsk presents positive results from phase iii fulfil study of closed triple combination therapy ff/umec/vi versus symbicort® turbohaler® in copd at ers international congress . Study which reported headline results in june 2016, met its two co-primary endpoints .Plans are on schedule for regulatory submissions of closed triple combination therapy for copd in us and europe by end of 2016.  Full Article

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Exclusive: Novartis in talks to sell some central nervous system drugs - sources

ZURICH Novartis is in talks about the sale of some older neuroscience drugs, people close to the matter said, as the Swiss drugmaker clears the decks to concentrate on promising new medicines it hopes will help to restore sales growth.