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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According to the United Nations Children's Fund (UNICEF) definition, an orphan is classified as a child aged <18 years who has lost one or both parents to any cause of death, while a double orphan is one who has lost both parents.[22] Baseline orphan status was defined as a child who had lost one or both parents prior to, or up to 6 months after, the date of ART initiation.
In the bivariate logistic regression analysis, district, age, sex, number of siblings, duration of stay, counseling service, suicidal ideation, medical illness, orphan status, and physical abuse showed the association with the outcome variable.
The EU Orphan Works Directive does offer a valid solution with the 'mutual recognition' principle--once a work is declared as having orphan status, it will have this status across the 28 EU Member States, thus enabling institutions to proceed with their digitisation and dissemination activities, with a minimal risk of liability.
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.S., or that affect 200,000 or more people, but where sales are not expected to recover the costs of research and development of the product.
The same therapy received orphan status from the US previously.
Also the patient's related factors like age, gender, education, orphan status, and missed doses were sought.
Revlimid, Celgene's flagship drug, which has orphan status for multiple myeloma and many other cancers, had sales of $5.8 billion in 2015.
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?' (0 = no, 1 = yes, 2 = I don't know; double orphan: mother and father have died (0 = no, 1 = yes).
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 independent variables in this study are age, attendance of school, migration status, basic deprivation, occupation, orphan status and living arrangement.
When differences in fertility by orphan status do emerge in the literature, they are implicitly ascribed to increased structural vulnerability (e.g., poverty) and related sexual risk-taking among orphans.