orphan drug

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Related to Orphan status: Orphan Drug Act

orphan drug,

drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the development and manufacturing of such drugs, which otherwise might not be profitable because of the small potential market. (Of the 5,000 diseases covered under the act, 47% affect fewer than 25,000 people.) The law has led to the introduction of valuable new drugs for the treatment of rare diseases, but some drug companies have been accused of abusing the law's provisions by making inordinately high profits on orphan drugs under monopoly. Since the 1983 act went into effect, many orphan drugs have been approved, including those for the treatment of such conditions as AIDSAIDS
or acquired immunodeficiency syndrome,
fatal disease caused by a rapidly mutating retrovirus that attacks the immune system and leaves the victim vulnerable to infections, malignancies, and neurological disorders. It was first recognized as a disease in 1981.
..... Click the link for more information.
, cystic fibrosiscystic fibrosis
, inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males.
..... Click the link for more information.
, blepharospasm (uncontrolled rapid blinking), and snake bite.

orphan drug

[¦ȯr·fən ′drəg]
(pharmacology)
A pharmaceutical developed to treat a disease that afflicts relatively few people.
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References in periodicals archive ?
The more contentious issue is whether the UK Government will continue to observe certain EU-wide principles which allow ongoing acceptance of the orphan status of works, within and without the UK, as well as features which would ameliorate future cross-border transactions.
The independent variables in this study are age, attendance of school, migration status, basic deprivation, occupation, orphan status and living arrangement.
In general, many indications that would qualify for orphan status are serious or life-threatening conditions which might also qualify for expedited designations.
Stuart Needleman, president and chief operating officer of Aptuit, said, "Because of the drug's orphan status and the high unmet medical need of patients, on-time and in-full delivery of the API is crucial.
Cultural works - photos, films, works of literature, etc - granted orphan status, ie whose copyright holders cannot be found, may be made public throughout the EU in digital form but only for non-lucrative purposes.
This orphan status is quite comparable to the labeling of federally recognized tribes as wards of the state when Chief Justice John Marshall deemed them "domestic dependent nations" in 1831.
NORDIC BUSINESS REPORT-December 23, 2010--Swedish Orphan Biovitrum says haemophilia A drug gets orphan status in USA(C)2010 M2 COMMUNICATIONS http://www.
ImmunoGen said it also received a positive opinion from European regulators on granting orphan status to the drug, lorvotuzumab mertansine, formerly known as IMGN901.
The policy paper said an EU-wide common 'due diligence' standards for recognising orphan status across Europe would be developed.
In multivariate analysis adjusted for age, community setting, socioeconomic status and orphan status, women's experience of sexual violence was positively associated with depression, suicidal thoughts, unwanted pregnancy, pregnancy complications or miscarriage, sexually transmitted infections, difficulty sleeping and use of alcohol (odds ratios, 1.
But Cassandra is less than impressed with Lee's overtures because of her fascination with Cassandra's orphan status.
The Orphan Drug Act was enacted to allow the FDA to grant special orphan status when it is intended to treat rare diseases or conditions--those that affect fewer than 200,000 in the US.