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An orphan drug is a drug for a rare disease that fulfils regulatory requirements to receive certain state incentives.
Although originally an orphan drug, ACME’s WellRun was also found to be effective in treating athlete’s foot.
Incentives for orphan drugs are provided to make it profitable for the pharmaceutical company to develop and manufacture the drug. Orphan drugs are defined in the US and in the EU and are subject to specific legislation. The incentives may include waivers of the necessary regulatory fees, market exclusivity for a certain period, and subsidies for associated research and development expenses. The rare diseases which orphan drugs aim to diagnose, prevent or treat are sometimes called orphan diseases.
Sirotčí lék je lék na vzácnou chorobu, který splňuje regulatorní požadavky pro získání určité státní podpory.
Ačkoli byl WellRun společnosti ACME původně sirotčím lékem, bylo objeveno, že je také účinný na léčbu atletické nohy.
Podpora pro sirotčí léky je poskytována, aby bylo pro farmaceutické společnosti výhodné vyvinout a vyrobit tento lék. Sirotčí léky jsou definovány v USA i EU a podléhají konkrétní legislativě. Podpora může zahrnovat odpuštění nezbytných regulatorních poplatků, tržní exkluzivitu na určitou dobu a dotace na související náklady na výzkum a vývoj. Vzácné nemoci, které sirotčí léky mají diagnostikovat, předcházet nebo léčit, se někdy nazývají sirotčí nemoci.
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English Editorial Services’ mission is to assist international businesses and organizations of all sizes to communicate clearly, correctly, and persuasively with their business partners and target audiences.
Simply subscribe to receive our Business Term of the Day at no charge to your inbox each business day, with explanation in English and Czech.
