EMA extends market authorisation for Alexion Pharma’s eculizumab


London – The European Medicines Agency has extended the therapeutic range of Soliris (eculizumab), a humanised monoclonal anti-C5 antibody that blocks terminal activation of the complement cascade of the human immune system. According to the Agency’s CHMP, treatment of paediatric and adult patients with the rare disease atypical haemolytic uraemic syndrome (aHUS) will be included provided that special precautionary measures are taken to prevent meningococcal infections. aHUS is characterised by hemolysis and thrombocytopenia, resulting in the formation of multiple blood clots in small blood vessels (so-called thrombotic microangiopathy, TMA). Patients with TMA require dialysisto prevent permanent kidney damage. The approval of eculizumab is based on 2 prospective open-label studies in adults and children. After treatment with Soliris 16 out of 20 adult patients achieved a stable platelet count over 12 weeks and no longer required plasma exchange or dialysis. Additionally renal function significantly improved. In children, the improvement was even better, with 93% of patient platelet count normalised. Most frequent adverse effects were hypertension, upper respiratory tract infection, and diarrhoea. In Europe, patients must be vaccinated with a tetravalent jab against meningococcus, because Soliris increases patient’s susceptibility to infections with Neisseria meningitidis.



London - The not-for-profit UK Biobank, the most comprehensive health study in Britain, is now accessible to researchers from industry and academia. The resource, which contains some 1,000 pieces of health and lifestyle...



London – The British Wellcome Trust announced on 20 March that it will launch a £200m business to invest directly in healthcare and life sciences companies. The business, up to now running under its working title Project Sigma,...



Nanopore sequencer Oxford Nanopore Technologies, a UK firm that promises its third-generation technology could theoretically sequence a human genome in 15 minutes, impressed scientists with the first public presentation of its...



GlaxoSmithKline (GSK) is further strengthening its activity in the area of rare diseases. The London-based pharma giant has signed an early-stage deal to develop and commercialise treatments for lysosomal storage disorders...



London/Montreal - Angiochem will collaborate with British pharma trust GlaxoSmithKline (GSK) plc on treatments for lysosomal storage diseases (LSD). London-based GSK will pay $300m, including up to $31.5m in upfront cash and...



London - GlaxoSmithKline re-adjusts its €3.7bn R&D budget. Following a review, three of 38 R&D units will be cut and four new ones installed, the UK drug company said in a statement on 7 Februray. Furthermore, six of the...



London - AstraZeneca tries to shed some weight, anticipating a tough year ahead. 7,300 jobs will be gone soon, the Anglo-Swedish drug company said in a statement. Research and development operations will be cancelled in...



Newhouse – An example of Schumpeter's dictum of creative destruction can be witnessed in Scotland. A former research site of US-pharma company Merck will be reborn as a biotech science park. BioCity Scotland Ltd, a joint venture...

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