GSK Press Releases - EIN Presswire - Press Release Distribution Service

Published on September 10, 2013 - 20:17 GMT

FDA Advisory Committee recommends approval in US of umeclidinium/vilanterol for the treatment of COPD

Issued: 10th September 2013, London UK and South San Francisco, CA, USA GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration ( …

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Published on September 9, 2013 - 09:23 GMT

GSK reaches agreement to divest Lucozade and Ribena for £1.35 billion

Issued: Monday 9 September 2013, London UK – LSE Announcement GlaxoSmithKline (LSE:GSK) today announced it has reached agreement to sell its nutritional drinks brands Lucozade and Ribena to Suntory Beverage Food Ltd (SBF), the Japanese consumer goods …

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Published on September 5, 2013 - 07:16 GMT

The investigational MAGE-A3 antigen-specific cancer immunotherapeutic does not meet first co-primary endpoint in Phase III ...

-In line with the Independent Data Monitoring Committee’s (IDMC) unanimous recommendation,GSK will continue the DERMA trial until the second co-primary endpoint is assessed Issued: Thursday 5 September 2013, London UK – LSE announcement GlaxoSmithKline plc …

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Published on September 2, 2013 - 11:38 GMT

GSK receives marketing authorisation from the European Commission for Tafinlar™ (dabrafenib), an oral treatment for unresectable ...

Issued:Monday 2 September 2013, London, UK GlaxoSmithKline plc announced today that the European Commission has granted marketing authorisation for Tafinlar™ (dabrafenib) as an oral targeted treatment indicated in monotherapy for unresectable melanoma ( …

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Published on August 23, 2013 - 14:24 GMT

GSK announces phase III study of vercirnon in patients with moderate-to-severe Crohn’s disease did not meet its primary endpoint

GlaxoSmithKline (GSK) announced today that the first of four Phase III studies, the SHIELD-1 study, investigating vercirnon - an investigational CCR9 antagonist - in adult patients with moderately-to-severely active Crohn’s disease did not achieve the …

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Published on August 14, 2013 - 16:39 GMT

GSK receives marketing authorisation from the European Commission for additional indication: Tyverb™ (lapatinib) in combination ...

GlaxoSmithKline announced today that the European Commission has granted an additional indication for Tyverb™ (lapatinib) to be used in combination with trastuzumab. This combination is indicated for adult patients with breast cancer whose tumours …

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Published on August 13, 2013 - 01:39 GMT

ViiV Healthcare announces U.S. approval of Tivicay® (dolutegravir) for the treatment of HIV-1

London, UK, 12 August, 2013 ViiV Healthcare is pleased to announce today that the U.S. Food and Drug Administration (FDA) has approved Tivicay® (dolutegravir) 50-mg tablets. Tivicay is an integrase inhibitor indicated for use in combination with other …

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Published on August 8, 2013 - 08:42 GMT

GSK launches $50 million venture capital fund to invest in pioneering bioelectronic medicines and technologies

Issued: Thursday 8 August 2013, London UK and Philadelphia, PA - 'Action Potential Venture Capital' makes first investment in SetPoint Medical, developer of implantable device for treating inflammatory diseases - GSK to stimulate RD collaboration …

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Published on August 7, 2013 - 11:46 GMT

Regulatory Update - GSK announces EU submission seeking additional indication for Votrient® as maintenance therapy for advanced ...

Issued: Tuesday 6 August 2013, London UK GlaxoSmithKline (GSK) plc today announced submission to the European Medicines Agency of a variation to the Marketing Authorisation for Votrient® (pazopanib), adding the additional indication for the maintenance …

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Published on August 7, 2013 - 11:46 GMT

Regulatory update – GSK announces EU submission for Cervarix® two dose schedule

Issued: Wednesday 7 August 2013, London UK GlaxoSmithKline (GSK) plc today announced the submission of a regulatory application in the European Union for a two dosing schedule in 9-14 year old girls for its cervical cancer vaccine, Cervarix ® [Human …

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Published on August 2, 2013 - 16:07 GMT

Regulatory update: albiglutide US PDUFA date extended by three months

Issued: Friday 2August 2013, London UK GlaxoSmithKline plc (LSE:GSK) today announced that the US Prescription Drug User Fee Act (PDUFA) goal date for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes, has been …

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Published on July 29, 2013 - 12:10 GMT

GSK adds to its commitment to GAVI Alliance to help protect millions more children against infectious diseases

Issued: Monday 29 July 2013, London UK New extension of Synflorix vaccine supply agreement will help protect an additional 80 million children in the world’s poorest countries from pneumococcal disease GlaxoSmithKline (GSK) announced today it has increased …

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Published on July 26, 2013 - 12:54 GMT

GSK receives positive CHMP opinion for REVOLADETM in thrombocytopenia associated with chronic hepatitis C infection

Issued: Friday 26 July 2013, London UK Today, GlaxoSmithKline plc (GSK) announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for REVOLADETM ( …

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Published on July 24, 2013 - 11:34 GMT

Results announcement for the second quarter 2013

Wednesday 24 July 2013, London UK GSK announces Q2 core EPS growth of4% and dividend of 18p Core EPS growth of 4% on sales growth of 2% (both CER) Pharma Vaccines +1%; US +5%; EMAP +2%; Europe flat; Japan -5% Consumer Healthcare +2% (+5% excluding …

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Published on July 22, 2013 - 19:11 GMT

Update on GSK Consumer Nigeria plc Scheme of Arrangement

Issued: Monday 22 July 2013, London UK – LSE Announcement GlaxoSmithKline plc (“GSK”) (LSE:GSK) and GlaxoSmithKline Consumer Nigeria PLC (“GSK Nigeria”) today announced that they have agreed that the scheme of arrangement proposed to GSK Nigeria’s …

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Published on July 22, 2013 - 10:46 GMT

GSK statement regarding recent meeting with Chinese authorities

22 July 2013 Following a meeting with the ChineseMinistry of Public Security to discuss their investigation into GSK, Abbas Hussain, President International – Europe, Japan, Emerging Markets Asia Pacific said: “We have had a very constructive meeting with …

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Published on July 15, 2013 - 13:26 GMT

GSK response to China investigation

15 July 2013 In response to the ongoing investigations by government authorities in China regarding our business in the country, GSK has issued the following statement: We are deeply concerned and disappointed by these serious allegations of fraudulent …

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Published on July 12, 2013 - 09:16 GMT

Regulatory update: fluticasone furoate/vilanterol submission in Japan

Issued 12 July 2013, London UK and San Francisco CA GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX)today announced that the licence application for the use of fluticasone furoate (FF) and vilanterol (VI) (proposed brand name RELVARTM ELLIPTATM)in …

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Published on July 9, 2013 - 09:43 GMT

Regulatory update – GSK announces US submission for dabrafenib/trametinib combination in metastatic melanoma

Issued: Tuesday9 July 2013, London UK- LSE announcement GlaxoSmithKline (GSK) plc today announced submission of supplemental New Drug Applications (NDAs) to the US Food and Drug Administration for use of dabrafenib, a BRAF inhibitor, in combination with …

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Published on June 28, 2013 - 12:47 GMT

Regulatory Update - GSK receives positive CHMP opinions for Tafinlar® (dabrafenib) and Tyverb® (lapatinib)

Issued: Friday 28 June 2013, London UK Today, GlaxoSmithKline plc (GSK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending marketing authorisation for two cancer drugs. CHMP issued …

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