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26-Jan-2012 - The time for commercial development of gene therapy has come. Patients with diseases treatable and curable with gene therapy deserve access to the technology, which has demonstrated both its effectiveness and feasibility, says James Wilson, MD, PhD, Editor-in-Chief of Human Gene Therapy in a ...
05-Jan-2012 - Amsterdam Molecular Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its gene therapy program for the treatment of hemophilia B. Orphan designation in the U.S. could provide up to seven years market exclusivity on regulatory approval. ...
20-Dec-2011 - Pharming Group NV announced that it has signed a service agreement with Renova Life, Inc. The agreement covers the development and supply of founder transgenic rabbits from RLI to Pharming. The founder rabbits will enable Pharming to start the commercial production breeding process. The first ...
01-Jun-2011 - CSL Behring announced that it has been granted Orphan Drug Designations (ODD) by the European Commission for the development of its recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP), a novel therapy to treat hemophilia A and hemophilia B patients with inhibitors. ...
10-May-2011 - Biogen Idec and Swedish Orphan Biovitrum announced that the European Medicines Agency's (EMA) Pediatric Committee (PDCO) has adopted an opinion agreeing to the pediatric investigational plan for the companies' long-lasting, fully-recombinant Factor IX Fc fusion protein (rFIXFc).In accordance with ...
06-Apr-2011 - University of Michigan researchers have created the state’s first human embryonic stem cell lines that carry the genes responsible for inherited disease. The achievement will enable scientists here to study the onset and progression of genetic disorders and to search for new treatments.With this ...
24-Sep-2010 - Swedish Orphan Biovitrum announced that the European Commission has granted orphan drug designation to its long-lasting, fully-recombinant Factor FVIII Fc fusion protein (rFVIIIFc), which is partnered with Biogen Idec. It was recently announced that the companies plan to advance the rFVIIIFc ...
10-Aug-2010 - A new study conducted in the department of Biochemistry and Molecular Biology at Tel Aviv University (TAU) elucidates the way in which toxic, yet essential, copper ions enter human cells. As a chemotherapy drug presumably enters the cells in a similar manner, the results of this study pave the ...
13-Jul-2010 - Biogen Idec and Swedish Orphan Biovitrum announced that they plan to advance the companies' long-lasting, fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial in people with hemophilia A. The decision to advance the program is based on promising data ...
03-Jun-2010 - Using high-throughput sequencing to map the locations of a common type of jumping gene within a person’s entire genome, researchers at the University of Pennsylvania School of Medicine found extensive variation in these locations among the individuals they studied, further underscoring the role ...
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