GlaxoSmithKline - Articles and news items

GSK statement on agreements with State Attorneys General on former Cidra manufacturing facility

Industry news, News / 23 June 2011 / GlaxoSmithKline

GlaxoSmithKline (GSK) has agreed to pay $40.75 million, which will be divided among 37 states and the District of Columbia, as part of an agreement reached related to events during the early 2000s at its former manufacturing facility in Cidra, Puerto Rico.

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GSK to purchase Shenzhen Neptunus stake in previously formed joint venture for influenza vaccines in China

Industry news, News / 14 June 2011 / GlaxoSmithKline

GlaxoSmithKline (GSK) announced today that it has entered into an agreement to acquire the remaining 51% equity interest of Shenzhen Neptunus Interlong Bio-Technique Co. Ltd (Neptunus) in the joint venture (JV) company, Shenzhen GSK-Neptunus Biologicals Co. Ltd. (GSKNB), for a total cash consideration of£24 million (US$39 million). After approval of this agreement by the Peoples Republic of China’s authorities, GSK will become the sole owner of GSKNB.

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GlaxoSmithKline and Valeant announce US FDA approval of Potiga™ (ezogabine)

Industry news, News / 13 June 2011 / GlaxoSmithKline

GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) announced today that the U.S. Food and Drug Administration (FDA) has approved Potiga™ (ezogabine) Tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.

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Children in the world’s poorest countries could receive vaccination against rotavirus diarrhoeal disease

Industry news, News / 6 June 2011 / GlaxoSmithKline

GSK today announced that it has made a new offer to supply its rotavirus vaccine, Rotarix™, to the GAVI Alliance at $2.50 per dose, a small fraction of developed world prices. This announcement is part of the company’s efforts to increase access to its medicines and vaccines in the world’s poorest countries. It is estimated that more than half a million children die of rotavirus gastroenteritis each year – the equivalent of a child a minute worldwide[i] – and it is responsible for the hospitalization of millions more.[ii] (more…)

GlaxoSmithKline’s pazopanib improved progression free survival in adults with certain soft tissue sarcomas

Industry news, News / 4 June 2011 / GlaxoSmithKline

Results of the PALETTE (PAzopanib ExpLorEd in SofT-Tissue Sarcoma) study presented at the 2011 Annual Meeting of the American Society for Clinical Oncology demonstrated a statistically significant improvement in the time to first occurrence of tumour progression or death (progression free survival or PFS) for study patients treated with the multi-tyrosine kinase inhibitor pazopanib, compared to placebo. PALETTE is a randomised, double-blind, placebo controlled Phase III trial in patients with metastatic soft tissue sarcomas (excluding gastrointestinal stromal tumours and adipocytic sarcomas) and was jointly conducted by GlaxoSmithKline and the European Organisation for Research and Treatment of Cancer (EORTC) in collaboration with cancer centres across the world. Use of pazopanib to treat soft tissue sarcomas is investigational and subject to evaluation of benefits and risks by regulatory authorities before being made available for that use.

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

Industry news, News / 20 May 2011 / GlaxoSmithKline

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 positive opinion, recommending marketing authorisation for Benlysta® (belimumab) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy.

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FDA approves GSK’s Lamictal®XR™ (lamotrigine)

Industry news, News / 27 April 2011 / GlaxoSmithKline

GlaxoSmithKline (GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Lamictal® XR™ (lamotrigine) Extended-Release Tablets for conversion to monotherapy in patients 13 years and older with partial seizures taking one anti-epileptic drug. This is a new indication for Lamictal XR which is already approved as add-on treatment for partial seizures and primary generalized tonic-clonic seizures in patients in this age group. Safety and effectiveness of Lamictal XR have not been established as initial monotherapy or for simultaneous conversion to monotherapy from two or more concomitant AEDs. (more…)

UV-Vis scan-based quality control of assay-ready plates for improved data integrity

Issue 2 2011 / 19 April 2011 / Gary K Smith, M Anthony Leesnitzer, Lois L Wright, Iona Popa-Burke, Trevor Casserly, Luke Miller, Melissa Gomez & Iris Scherer, GlaxoSmithKline

Quality biological data requires both a high quality assay and a high quality compound. While assay quality is very closely monitored and has been intensively studied in the past, the quality of the final compound solutions being tested in an assay has received little attention. Quality of these samples is critical to the screening process, especially for XC50 determinations used in structureactivity relationship (SAR) analyses. Many laboratories have implemented routine analytical quality control (QC) on the stock solutions of all compounds, as well as quality assurance (QA) procedures for the weighing and liquid handling instrumentation used to produce the final assay-ready plates. Unfortunately, the stock sample QC and instrumentation QA together do not address the issues of assay plate production; indeed, stock sample QC does not address what happens to the sample once it has entered a compound management solution store at all. (more…)

GSK publishes 2010 Corporate Responsibility Report

Industry news, News / 28 March 2011 / GlaxoSmithKline

In its Corporate Responsibility Report published today, GlaxoSmithKline (GSK) reiterated its commitment to building its business on strong values and ethical standards. The Report covers key responsibility issues including access to medicines, research and business ethics, environmental sustainability, employment practices, stakeholder engagement and investment in communities. In particular, new measures were outlined to strengthen the company’s commitment to the environment and increase access to medicines for people living in the world’s poorest countries. GSK also reported a substantive increase in its level of charitable support.

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AZ, Pfizer and GSK leaders endorse university’s Quality by Design course

Industry news, News / 28 March 2011 / De Montfort University

De Montfort University’s (DMU) unique Quality by Design (QbD) course received major endorsement by senior industry leaders when it was launched last week.

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

Industry news, News / 23 March 2011 / GlaxoSmithKline

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 will withdraw applications from regulatory review where procedures are ongoing and, in the limited number of countries where dutasteride is already indicated for use in prostate cancer risk reduction, GSK will work with regulatory agencies to remove this indication from the product’s licence and support physicians to communicate appropriately to patients.

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Advanced kidney cancer patients now able to access Votrient®▼ (pazopanib)

Industry news, News / 7 March 2011 / GlaxoSmithKline

From today, patients living in Scotland with advanced renal cell carcinoma, a type of kidney cancer, will have access to a new treatment choice, as Votrient® (pazopanib) is made available on the National Health Service (NHS Scotland).1 The Scottish Medicines Consortium (SMC) has issued advice to NHS Scotland on the use of Votrient for the first-line treatment of advanced renal cell carcinoma. Votrient is a targeted oral treatment, which has been shown to effectively slow down disease progression whilst maintaining quality of life compared with placebo.2-4

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