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EMA extends market authorisation for Alexion Pharma’s eculizumab

30.11.2011

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.

UKUK

22.12.2011

London - Nothing is well if the end is not well. For Astra Zeneca the end of 2011 isn't well at all. A new anti-ovarian cancer drug and a planned antidepressant have underperformed in tests. As a result, AstraZeneca will take a...

UKUK

17.12.2011

Surrey – The UK government is investing an additional £80m (€93.5m) to fund continued development of the Institute for Animal Health (IAH) at Pirbright, an institute of the Biotechnology and Biological Sciences Research Council...

UKUK

15.12.2011

Rijeka/London – Allergies like asthma or psoriasis might arise from environmental toxins, suggest researchers from Rijeka University (Croatia) and King’s College (London). In mice, they identified a special population of T cells...

UKUK

13.12.2011

London – Interesting times ahead in the European cancer treatment market. A report states that in the UK alone, diagnosis and treatment costs are likely to increase by 62%, from £9.4 billion in 2010 to £15.3 billion by 2021. The...

UKUK

12.12.2011

York - Tissue Regenix Group plc plans to raise €29m through the sale of 181.8 million shares. The regenerative medical device company is held within the IP Group portfolio and a spin-out company from the University of Leeds. The...

UKUK

11.12.2011

London – Cancer Research UK has begun recruiting patients in the first phase of its Stratified Medicine Programme, which is aimed at finding cancer biomarkers and establishing a genetic testing service in the UK. The charity’s...

UKUK

06.12.2011

London – British Prime Minister David Cameron is trying to come to the rescue of Britain’s embattled biopharmaceutical industry. He has earmarked €210m to support a “biomedical catalyst fund” to back early-stage academic and...

UKUK

06.12.2011

London - David Cameron plans to come to the rescue of Britain's embattled biopharmaceutical industry. The conservative prime minister has earmarked £180m (€210 million) to support a "biomedical catalyst fund" to back ...

UKUK

25.11.2011

Cancer Research UK has started recruiting patients in the first phase of its Stratified Medicine Program, which is seeking to find cancer biomarkers and establish a genetic testing service in the U.K. The charity's multi-million...

UKUK

24.11.2011

London – The European Medicines Agency has recalled all batches of the cancer drugs Busilvex, Velcade and Vidaza manufactured at Boehringer Ingelheim’s Ben Venue Laboratories facility in Bedford, Ohio, from the European market....

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