卫材(Eisai)8月9日宣布,FDA已授予实验性化合物E7777用于治疗皮肤T细胞淋巴瘤(CTCL)的孤儿药地位(orphan drug status)。E7777被设计成具有一种改善的纯度属性和制造工艺,目前正处于一个关键临床试验,相关数据将用于支持相关监管申请文件的提交。
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Orphan drug status provides the company with financial incentives to promote the development of a drug to treat a rare disease or condition.
稀少药品状态提供给药品公司金融鼓励,促使药品公司开发治疗稀少疾病的药物。
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At the time this process was initiated, neither orphan drug status or even the more limited Hatch Waxman period of exclusivity was guaranteed.
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In a course he teaches at Boston University, Astrue teaches students six ways of getting a drug approved when another treatment has received orphan drug status.
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Orphan-drug status, for example, can help a biotech firm raise capital on the strength of its latest product.
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