orphan drug

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Related to Orphan status: Orphan Drug Act

or′phan drug′


n.
a drug that remains undeveloped or is neglected because of limited potential for commercial gain.
[1975–80]
References in periodicals archive ?
The ODD programme provides orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 5 in 10,000 people in the EU.
As always at time of approval, this orphan designation will now be reviewed by EMAs Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining Amglidias orphan status and granting this medicine ten years of market exclusivity.
The granting of orphan status from the FDA in the US follows on from receiving orphan designation from the European Medicines Agency in early 2017.
British biotech Shire (LON: SHP) has had its investigational therapy SHP647's orphan status granted by US regulators, Pharma Times reported on Friday.
The cross-border orphan status relies on three key elements: an acceptance of the principle by all EU countries, a priori diligent search, and most importantly, a registration approach.
The FDA Orphan Drug Designation program provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.
The same therapy received orphan status from the US previously.
Revlimid, Celgene's flagship drug, which has orphan status for multiple myeloma and many other cancers, had sales of $5.
These included whether participants identified themselves as 'white', 'black', 'coloured' or 'other' ('race' classifications previously imposed by the apartheid government that continue to be associated with health inequalities and inequities in healthcare provision), age, gender and orphan status (maternal/paternal orphan: 'Is your mother/father alive?
Orphan status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases - those which affect fewer than 200,000 Americans annually.
An orphan drug designation is to encourage the development of medicines for rare diseases and provides orphan status to drugs and biologic sunder development.
The SMD program has orphan status both in Europe and the U.