market is attracting global pharmaceutical companies to invest in orphan drug
This report provides an analysis of the orphan drug
a product can be designated an orphan drug
if it is meant to treat an illness that affects fewer than 200,000 people.
We are gratified to have received rapid approval for this designation, which complements the orphan drug
designation that decitabine received in the U.
We appreciate the thoughtful review by the FDA of our orphan drug
application and believe that the incentives provided by the orphan drug
law are working well to bring new health care opportunities to patients with uncommon diseases,'' said L.
para]]In recent years, several new rare diseases are being included in clinical trials for the development of orphan drug
designation in the European Union provides a 10-year period of post-approval marketing exclusivity and other financial incentives for new drugs that offer significant therapeutic advantage over other approved treatments of rare conditions (conditions affecting no more than 5 in 10,000 persons).
The orphan drug
and balloon technologies discussed here illustrate the significant impact that very expensive, very low volume technologies and high volume, "cost saving" technologies might have on an individual plan.
Food and Drug Administration (FDA) that its autoimmune candidate drug GL-2045, a recombinant Intravenous Immune Globulin (IVIG)-mimetic, has been granted orphan drug
designation for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Act, as well as similar Acts in 1991 in Singapore, 1993 in Japan, 1997 in Australia and in 2000 by the European Union.
has announced that the Committee for Orphan Medical Products of the European Agency for the Evaluation of Medicinal Products (COMP/EMEA) has rendered a positive opinion on the company's application for orphan drug
designation in the European Community for rhASB (recombinant human arylsulfatase B), as enzyme replacement therapy for patients with Mucopolysaccharidosis (MPS) VI.
In 1983, Congress passed the Orphan Drug
Act to encourage development of pharmaceuticals used in the treatment or diagnosis of diseases that occur so rarely that there is no financial incentive for development of these so-called "orphan drugs