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An orphan drug is a pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the conditions. The conditions that orphan drugs are used to treat are referred to as orphan diseases. The ...
The Orphan Drug Act of 1983 is a law passed in the United States to facilitate development of orphan drugs—drugs for rare diseases such as Huntington's disease, myoclonus, ALS, Tourette syndrome or muscular dystrophy which affect small numbers of individuals residing in the United States.
But in the United States and the European Union, "orphan diseases" have a distinct legal meaning. The United States' Orphan Drug Act includes both rare diseases and any non-rare diseases "for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will ...
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An outdated law designed to spur drug development drives up the cost of new treatments, including those for Covid-19.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
Specialty drugs may also be designated as orphan drugs or ultra-orphan drugs under the U. S. Orphan Drug Act of 1983. This was enacted to facilitate development of orphan drugs—drugs for rare diseases such as Huntington's disease , myoclonus , amyotrophic lateral sclerosis , Tourette syndrome and muscular dystrophy which affect small numbers ...
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 ...
In some parts of the world, an ultra-orphan disease is a rare disease whose rarity means there is a lack of a market large enough to have support and resources for discovering treatments for it. [1] [2] [3] Distinct countries define and provide special economic incentives for companies developing drugs that treat ultra-rare diseases.