GSK Press Releases - EIN Presswire - Press Release Distribution Service

Published on May 20, 2011 - 11:10 GMT

GlaxoSmithKline and Human Genome Sciences receive positive opinion in Europe from the CHMP for Benlysta® (belimumab)

Issued: Friday 20 May 2011, London UK and Rockville, Maryland GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a …

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Published on May 13, 2011 - 12:10 GMT

Young people’s health charity steps forward to claim top accolade and £35,000

Issued: Friday 13 May 2011, London UK - Recognition for outstanding work with disadvantaged young people Tower Hamlets-based charity, Step Forward, has beaten more than 400 organisations from around the UK to be crowned the overall winner of …

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Published on April 18, 2011 - 13:10 GMT

Regulatory update – GSK and Valeant respond to FDA on ezogabine

Issued: Monday 18 April 2011, London UK, Research Triangle Park, NC & Mississauga, Ontario GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) submitted on 15 April 2011 the response to the U.S. Food and Drug …

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Published on April 18, 2011 - 12:10 GMT

GSK welcomes key agreement to support global preparedness against pandemic influenza

Issued: Monday 18 April 2011, London UK - Outcome of the Open Ended Working Group (OEWG) of Member States on Pandemic Influenza Preparedness, Geneva, April 11-15th 2011 GlaxoSmithKline (GSK) welcomes the agreement reached at the Open Ended …

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Published on April 15, 2011 - 16:11 GMT

Regulatory Update: GlaxoSmithKline submits additional information for candidate meningococcal and Hib combination vaccine

Issued: Friday 15 April 2011, Philadelphia, PA GlaxoSmithKline [NYSE:GSK] today submitted additional information to the U.S. Food and Drug Administration (FDA) in support of the Biologics License Application (BLA) for the candidate meningococcal and …

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Published on April 15, 2011 - 12:11 GMT

GSK European regulatory update on Pandemrix™

Issued: Friday 15 April 2011, London UK GlaxoSmithKline (GSK) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended changes to the product label for Pandemrix. The amendment …

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Published on April 15, 2011 - 09:12 GMT

Regulatory Update - Tyverb® (lapatinib)

Issued: Friday 15 April 2011, London UK GlaxoSmithKline plc (GSK) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Tyverb (lapatinib) in combination with paclitaxel for …

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Published on April 7, 2011 - 01:15 GMT

GlaxoSmithKline and XenoPort receive FDA approval for Horizant™

Issued: Thursday 07 April 2011, Issued: Wednesday, 6 April 2011, London, UK, Research Triangle Park, NC & Santa Clara, CA - New treatment for moderate-to-severe primary Restless Legs Syndrome GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq …

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Published on April 3, 2011 - 22:12 GMT

GlaxoSmithKline confirms Pronova BioPharma reaches agreement with Apotex regarding Lovaza™ US patent litigation

Issued: Wednesday 30 March 2011, London UK - Litigation continues between Pronova BioPharma and two other generic challengers GlaxoSmithKline (GSK), which has the marketing rights for Lovaza (omega-3-acid ethyl esters) in the US and Puerto Rico …

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Published on March 23, 2011 - 14:13 GMT

GSK statement on Avodart™ (dutasteride) for prostate cancer risk reduction

Issued: Wednesday 23 March 2011, London UK GlaxoSmithKline (GSK) announced today that it will no longer pursue global approval (marketing authorisation) for the use of Avodart™ (dutasteride) to reduce the risk of prostate cancer. The Company …

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Published on March 2, 2011 - 12:10 GMT

Regulatory update: Nimenrix® (MenACWY vaccine)

Issued: Wednesday 2 March 2011, London UK GlaxoSmithKline (GSK) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for its candidate conjugate meningitis vaccine, Nimenrix ®, …

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Published on March 1, 2011 - 12:15 GMT

World’s first everyday fluoride toothpaste with NovaMin® technology that can repair sensitive teeth

Issued: Tuesday 1 March 2011, London UK GlaxoSmithKline Consumer Healthcare, the maker of leading sensitive toothpaste brand Sensodyne®, today announced a breakthrough in dental care with the launch of new Sensodyne Repair & Protect. The …

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Published on February 11, 2011 - 17:14 GMT

First African country introduces GSK’s pneumococcal vaccine through innovative financing mechanism

- Rapid introduction of Synflorix™ in Kenya at around 90% discount to developed markets through first use of AMC in Africa - Enables vaccination of millions of children against pneumococcal disease Issued: Friday 11 February 2011, London, UK …

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Published on February 7, 2011 - 17:13 GMT

GlaxoSmithKline and Human Genome Sciences announce publication of BLISS-52 phase lll study results for Benlysta® in The Lancet

Issued: Monday 7 February 2011, London UK and Rockville, Maryland, US GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced publication of the BLISS-52 study of Benlysta® (belimumab) in autoantibody-positive …

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Published on January 12, 2011 - 14:10 GMT

GlaxoSmithKline and ChemoCentryx announce initiation of Phase III study of GSK’786, formerly Traficet-EN™, for the treatment of ...

Issued: Wednesday 12 January 2011, London, UK and Mountain View, CA, USA GlaxoSmithKline (GSK) and ChemoCentryx, Inc. announced today that the first patient with Crohn’s disease has initiated treatment in the initial pivotal induction study …

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Published on January 10, 2011 - 10:13 GMT

GlaxoSmithKline and Theravance commence MABA Phase IIb COPD study

Issued 21 December 2010, Philadelphia PA GlaxoSmithKline (GSK) and Theravance (NASDAQ: THRX) announced today that the first patient has started treatment with an investigational inhaled bifunctional compound GSK961081 (‘081) in a Phase IIb …

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Published on December 6, 2010 - 09:10 GMT

GlaxoSmithKline and Human Genome Sciences announce FDA extension of Benlysta® PDUFA target date to 10th March 2011

Issued: Friday 3 December 2010 GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target date for its …

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Published on November 29, 2010 - 17:12 GMT

Government patent box proposals ‘transform’ UK attractiveness for investment

Issued: Monday 29th November 2010, London, UK • GSK to invest £500m in manufacturing projects • New £50m UK venture capital fund to be established • New investment with academia on ‘green chemistry’ GSK welcomes the …

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