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Samples in periodicals archive:
About Orphan Medicinal Product Designation The COMP, one of seven scientific committees of the European Medicines Agency (EMA), is responsible for reviewing applications from companies seeking "orphan medicinal product designation" and making recommendations to the EC regarding these applications.
Speaking about the European Commission orphan medicinal product designation for liposomal daunorubicin, Mark Scrutton, President of Galen, commented: "We are delighted about the designation of liposomal daunorubicin as an orphan medicinal product for the treatment of acute myeloid leukaemia, a life-threatening disease.
Orphan medicinal product designation is conferred upon products for diseases that affect no more than 5 in 10,000 people in the European Union at the time of the submission.
13, 2013 /PRNewswire/ -- BHR Pharma, LLC announced today the European Medicines Agency (EMA), responsible for evaluating medicines developed for use in the European Union, granted an orphan medicinal product designation for treating moderate and severe traumatic brain injury (TBI) to its proprietary intravenous progesterone infusion agent, BHR-100.
Nasdaq: INGN) announced today Gendux was notified by the European Medicines Agency (EMEA) Committee for Orphan Medicinal Products that ADVEXIN(R) p53 therapy has received Orphan Medicinal Product Designation in Europe for the treatment of Li-Fraumeni Syndrome (LFS).
BioMarin and Genzyme have obtained Orphan Drug designation and Fast Track status for Aldurazyme for MPS I from the FDA and orphan medicinal product designation from the European Agency for the Evaluation of Medicinal Products (EMEA).
Chicago, IL, announced it has received its first Orphan Medicinal Product designation from the European Agency for the Evaluation of Medicinal Products (EMEA), the European drug regulatory agency, on its drug orBec for the treatment of intestinal Graft Versus Host Disease (GVHD).
About Orphan Drug Designation EMA's Orphan Medicinal Product Designation is designed to promote the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases, i.