Press releases
GSK European regulatory update on Pandemrix™
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 includes prescribing advice based on information on a potential increased risk of narcolepsy in children or adolescents. This is based onpreliminary results from epidemiological studies on the risk of narcolepsy from Finland, Sweden and France. This does not apply to adults where to date no data support such a change. The EMA state that this is an interim measure pending the outcome of the European review expected to conclude in July 2011.
GlaxoSmithKline announces non-core OTC products to be divested
GSK today identified the non-core OTC brands that it intends to divest as the company focuses its Consumer Healthcare business around a portfolio of fast-growing priority brands and the emerging markets. GSK’s intention to divest its non-core Consumer assets was announced at the company’s fourth quarter 2010 results on 3rd February 2011.
Unique research alliance expands collaboration opportunities at state-of-the-art medical imaging centre
The UK research community will soon have access to world-class medical imaging facilities in London with the signing of an agreement today between an alliance of leading London-based universities, the Medical Research Council (MRC) and the pharmaceutical company GlaxoSmithKline (GSK).
GlaxoSmithKline and XenoPort receive FDA approval for Horizant™
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults. Horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night. The efficacy of Horizant in the treatment of patients with moderate-to-severe primary Restless Legs Syndrome was demonstrated in two 12-week clinical trials in adults. It is the first medication in its class to be approved for the treatment of moderate-to-severe primary Restless Legs Syndrome.
GSK publishes payments for research consulting and advising by US healthcare professionals
GlaxoSmithKline (NYSE:GSK) today published a list of payments made during 2010 for clinical research studies led by U.S. healthcare professionals. Clinical trials are an important step in the lengthy process of discovering and developing new medicines. GSK works with these independent institutions and healthcare professionals because they have considerable expertise in conducting research that contributes to the body of knowledge about diseases and potential new treatments.
GlaxoSmithKline confirms Pronova BioPharma reaches agreement with Apotex regarding Lovaza™ US patent litigation
GlaxoSmithKline (GSK), which has the marketing rights for Lovaza (omega-3-acid ethyl esters) in the US and Puerto Rico, confirmed today that Pronova BioPharma Norge AS, which owns the patents for Lovaza, has entered into an agreement with Apotex Corp. and Apotex Inc. (collectively “Apotex”), to settle their patent litigation in the United States related to Lovaza.
GSK and Valeant receive European authorisation for Trobalt (retigabine)
GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) announced today that the European Commission has granted marketing authorisation for Trobalt™(retigabine) as an adjunctive (add-on) treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalisation in adults aged 18 years and above with epilepsy.1
GSK publishes 2010 Corporate Responsibility Report
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.
GSK statement on Avodart™ (dutasteride) for prostate cancer risk reduction
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.
GSK launches London 2012 initiative with King’s College London to inspire young people into science careers
At the launch of the new ‘Scientists in Sport’ education programme designed to inspire young people into a range of scientific careers, a study has found that eight out of 10 secondary school pupils are now worried about getting a job in the future.
