UKUK

GSK and HGS get approval for lupus drug

15.07.2011

London/Rockville - GlaxoSmithKline and its American partner Human Genome Sciences, Inc. announced today that the European Commission has granted marketing authorisation for belimumab (Benlysta) 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. "We and GSK are committed to making Benlysta available in countries worldwide," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "We are particularly honoured to be bringing this medicine forward in Europe, where a number of key academic research institutions were very important to its clinical development." Belimumab received approval from the U.S. FDA on March 9, 2011. GSK and HGS announced approval from Health Canada on July 12, 2011. Regulatory applications have been submitted and are currently under review in Australia, Switzerland, Russia, Brazil, The Philippines, Israel, Singapore, Taiwan and Colombia. HGS and GSK have been working together on belimumab since 2006. Under the agreement, HGS had responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialised under the current agreement.

Politics / Law, UKUK

09.07.2007

London – The European Medicines Agency EMEA will be facing problems if the authority’s latest predictions for the number of applications for clinical trials with children approve to be correct. In January, the EMEA predicted that...

UK, Tech ReviewUK

17.05.2007

London – At the end of April, a health technology assessment from the UK National Institute for Health Research gave the green light for the funding of a head-to-head trial of Genentech’s Lucentis and off-label product Avastin...

UK, Tech ReviewUK

17.05.2007

Suffolk – British crop researchers possibly have found a way to prevent genetically engineered crops from reducing the biodiversity of weeds and seeds. Based on data of the UK government‘s Farm Scale Evaluations (FSE) in the year...

UKUK

16.05.2007

London – AstraZeneca has made a large step into vaccines and other biotech drugs by acquiring the US biotech group MedImmune for US-$ 15.2 billion. The deal gives Britain’s second largest pharmaceutical company access to...

UKUK

16.05.2007

London – The National Extremism Tactical Coordination Unit (NETCU), which forms part of the UK’s national policing response to domestic extremism, has said that police have arrested 30 people who are suspected of being involved...

UKUK

16.05.2007

London – British politicians have criticised their government for proposing a ban on the creation of “chimaric” embryos, made from human DNA inserted into an animal egg. The Select Committee on Science and Technology, which is...

UKUK

16.03.2007

London – Experiments with embryos created by fusing human DNA with ‘empty’ animal eggs could be exempted from a ban on research using other human-anmial hybrid embryos, the Public Health Minister Caroline Flint has said. While...

UKUK

16.03.2007

Nottingham – Biocity Nottingham, one of the bioscience incubators in Britain’s East Midlands, is starting a third phase of development at its site. The measures will lead to an extra 4,000 m2 of available laboratory space for...

UKUK

16.03.2007

Cambridge – Cancer Research UK, the leading cancer charity in Great Britain, has opened a a70 million research institute in Cambridge in cooperation with Cambridge University. The institute will employ more than 300 researchers...

UKUK

16.03.2007

London – The German pharma company Merck KGaA has lost its appeal against a decision by the UK’s National Institute for Health and Clinical Excellence (NICE) not to recommend the antibody Erbitux for the treatment of metastatic...

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