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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.
According to Thomson Reuters in their 2012 publication "The Economic Power of Orphan Drugs", there has been increased investing in orphan drug research and development partly since the U.S. Congress enacted the Orphan Drug Act, giving an extra monopoly for drugs for "orphan diseases" that affected fewer than 200,000 people in the country. [13]
An outdated law designed to spur drug development drives up the cost of new treatments, including those for Covid-19.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
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 ...
BioMarin Pharmaceuticals (NAS: BMRN) keeps chugging along, pushing its orphan drug pipeline forward. Yesterday, the biotech announced data from two trials, giving the company confidence to move ...
Prior to the RDA was the Orphan Drug Act of 1983, which was designed to facilitate the development and commercialization of drugs to treat rare diseases, termed orphan drugs. This act, however, did not provide for the creation of a centralized structure able to coordinate research or recommend agendas that would better facilitate research and ...
The FDA currently does not have a definition of orphan devices or orphan medical technology. The closest resembling definition is that of a humanitarian use device, which is "a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year".