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The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy that depends on the legislation (if there is any) of the country. Designation of a drug as an orphan drug has yielded medical breakthroughs that might not otherwise have been achieved, due to the economics of drug research and ...
While orphan drug status is given to drugs with "no reasonable expectation" of profitability, some orphan drugs have gone on to net large profits and/or receive widespread use. [17] The topic of profit in the aftermath of the ODA was addressed in November 2013 in the Seattle Times where the following quote appeared: [7]
Lists of all drugs that have received orphan status in the United States and Europe are available from the U.S. Food and Drug Administration and the European Commission, respectively: FDA List of Orphan Designations and Approvals [dead link ] European Commission Register of designated Orphan Medicinal Products
Orphan drug status, which is given to drugs meant for the treatment of rare diseases, offers drug developers a path to faster approval and enhanced market exclusivity. So let's look at a small ...
An outdated law designed to spur drug development drives up the cost of new treatments, including those for Covid-19. How to fix the orphan drug problem driving up medical costs Skip to main content
NPS Pharmaceuticals is bringing its kids home. The biotech announced yesterday that it had reacquired the ex-North America rights to two drugs -- Revestive and Preotact -- that were licensed to ...
Orphan drug status. Otelixizumab has been granted "orphan drug" status by the U.S. Food and Drug Administration. [10] Chemistry. As a monoclonal antibody, ...
The FDA bestows an orphan drug designation on Reata Pharmaceuticals' (RETA) candidate, bardoxolone, for treating patients with autosomal dominant polycystic kidney disease.