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GlaxoSmithKline PLC (GSK.L)

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Latest Key Developments (Source: Significant Developments)

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

GlaxoSmithKline sees positive results from COPD Salford Lung study
Monday, 5 Sep 2016 02:00am EDT 

Glaxosmithkline Plc : Positive results from the copd salford lung study . Announce positive results from copd salford lung study published in nejm and presented at european respiratory congress .Results from sls provide robust evidence that will enable healthcare community to begin to understand how choice of copd treatment can significantly influence patient outcomes..  Full Article

DR. Reddy's laboratories says launch of Bupropion HCL extended-release tablets, USP (sr) in U.S. market
Friday, 2 Sep 2016 11:32am EDT 

Dr.Reddy's Laboratories Ltd :Launch of bupropion hcl extended-release tablets, usp (sr) in u.s. Market.  Full Article

GSK Consumer Healthcare announces Flonase allergy relief for OTC use in Canada
Wednesday, 31 Aug 2016 05:09pm EDT 

GlaxoSmithKline Plc : GSK Consumer Healthcare - Approval of flonase allergy relief for over the counter use in Canada .GSK Consumer Healthcare - Flonase allergy relief will be available over the counter in early 2017.  Full Article

Gsk Consumer Healthcare says FDA approved Flonase Sensimist allergy relief as OTC treatment
Wednesday, 3 Aug 2016 08:03am EDT 

Glaxosmithkline Plc :FDA approved flonase sensimist allergy relief as otc treatment for symptoms associated with seasonal and perennial allergies.  Full Article

Vectura initiates legal proceedings against GSK in the U.S.
Wednesday, 27 Jul 2016 12:19pm EDT 

Vectura Group Plc : Vectura initiates legal proceedings against GlaxoSmithKline Plc (GSK) . Vectura has filed a patent infringement lawsuit against GSK claiming infringement of Vectura's U.S. patents in Delaware district court . Continues to remain open to finding a mutually acceptable solution in order to avoid costs and potential uncertainty over royalties that have, up to now, been subject to a cap of 13 mln stg per calendar year . Separate licence agreement with GSK relating to legacy Skyepharma dry powder formulation technology used in Ellipta products is unaffected .Despite notification from GSK, directors believe that revenues for current financial year ending December 2016 remain in line with current expectations.  Full Article

GSK CEO: UK competitive post-Brexit but questions over drug regulation, science
Wednesday, 27 Jul 2016 07:00am EDT 

GlaxoSmithKline CEO told reporters: Ceo says board looking at internal and external candidates to be new ceo, decision around end year . Ceo says sees reopening of conversations on drug pricing in europe and u.s. in 2017 . Ceo says sees evolution on drug pricing, changes to more outcomes-based models likely in 2018 and 2019 . Ceo says fundamental competitiveness of uk remains exactly the same as before brexit vote . Ceo says q2 tends to be weaker quarter for consumer business, still expects margin to get to 20 percent mid term . Ceo says expectation is that EMA will move from london, "somewhat concerned" that may bring disruption . Ceo says risk of scientific brain drain post-brexit is "question-mark we should all be concerned about" Further company coverage: [GSK.L] (Reporting by UK bureau) ((uk.online@reuters.com;)).  Full Article

GlaxoSmithKline ships 2016-17 seasonal influenza vaccines for US market
Wednesday, 20 Jul 2016 03:51pm EDT 

GlaxoSmithKline Plc : GSK ships 2016-17 seasonal influenza vaccines for US market .Expects to supply up to 40 million doses across both vaccines for US market in 2016-17 season.  Full Article

ARIA study shows superior efficacy of Triumeq for treatment-naïve women with HIV
Monday, 18 Jul 2016 06:16am EDT 

Viiv Healthcare: ARIA study shows superior efficacy of Triumeq for treatment-naïve women living with HIV .Both non-inferiority and superiority endpoints were met.  Full Article

Mylan launches generic version of GSK's avodart capsules
Friday, 24 Jun 2016 11:44am EDT 

Mylan NV: Mylan launches generic Avodart® capsules .U.S. launch of Dutasteride capsules, 0.5 mg, generic version of GlaxoSmithKline's avodart capsules.  Full Article

BRIEF-GlaxoSmithKline submits marketing application for shingles vaccine to EMA

* GSK announces EU regulatory submission of candidate vaccine for prevention of shingles