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.

UKUK

26.02.2008

London – The UK has introduced changes to its patent laws to bring them into line with the revised European Patent Convention (EPC), which came into effect end of last year. Among other things, the changes clarify the...

UKUK

19.02.2008

London – Researchers from Queen Mary’s School of Medicine and Dentistry in London have found a new target that seems to inhibit wound healing (JCI, 5. Feb. 2008). According to Dr. Kairbaan Hodivala-Dilke, inhibition of Smad7 may...

UKUK

19.02.2008

London – The UK government will increase funding for the National Center for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). Funding will grow gradually to about EUR7 million in 2010 from the current...

UKUK

19.02.2008

Glasgow – ClinTec International, a CRO based in the UK, is moving it global headquarters to Scotland from its current offices in Windsor. The office will be in Glasgow, Scotland. The headquarters will house all of the company’s...

UKUK

19.02.2008

London – Proposed changes to NICE’s guide to its methods will make its use of cost per quality-adjusted life year (QALY) in health technology assessments clearer, the institute says. NICE officials at the institute’s annual...

BioFunding, UKUK

19.02.2008

London – Medgenics Inc raised EUR4.7 million in an IPO on London’s AIM. The company sold 31.6 million shares at 10 p, giving it a valuation of about EUR15 million. Medgenics’ biopump technology is an implantable, toothpick-sized...

Austria, UKUK

22.11.2007

Vienna/Norwich – Austrian and British researchers have come up with a new method for predicting a food’s potential to cause an allergic reaction (J. Allergy Clin. Immunol., Oct. 10). According to the scientists from the...

UKUK

22.11.2007

Oxford – Oxford Immunotec has closed a financing round for a27 million. The funding of the British company marks the largest financing for a diagnostics specialist in Europe in the past two years. It was co-led by new investors...

UKUK

22.11.2007

Wilton – The UK has established a test bed for developing cleaner and more sustainable biotech-based processes, the National Industry Biotechnology Facility (NIBF) in Wilton. The a17 million facility is sited at the Centre for...

UKUK

22.11.2007

London – British drug developer Ark Therapeutics plc has raised a53 million in a placing of 35.6 million shares at 105p, which is a 3% discount on the company’s close before the measure was announced. The move was underwritten by...

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