Regulatory evaluation of Glybera in Europe — two committees, one mission

2013

Representing the first gene therapy to be approved in the Western world, alipogene tiparvovec (Glybera; Uniqure) has recently been said to have had a “substantial impact from a regulatory perspective” (Nature Rev. Drug Discov. 11, 664; 2012) 1 . The therapy was granted marketing authorization in the European Union for the treatment of lipoprotein lipase deficiency, which results in a clinically heterogeneous condition with a risk of potentially life-threatening pancreatitis 2 , at the end of 2012. The decision followed a positive opinion by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) 3

Association of genetic variants with pancreatic cancer

2007

Role of endoscopic ultrasonography in the evaluation of high risk pancreatic cystic lesions: Ten year single center experience

2012

s / Pancreatology 12 (2012) 502–597 530 selenium content in second group was increased up to 96,5 3,29 mg/l (p <0,001). Conclusions: SS is an effective drug in treatment of selenium deficiency and could be used in initial complex therapy for pain relief in CP.