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Dinutuximab
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Dinutuximab : ウィキペディア英語版
Dinutuximab

Dinutuximab (tradename Unituxin) is the first treatment for high-risk neuroblastoma in pediatric patients, that received FDA approval on March 10, 2015.〔(【引用サイトリンク】url=http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437460.htm )〕 It was initially developed by a federal agency, the U.S. National Cancer Institute in partnership with the Children’s Oncology Group. In 2010 United Therapeutics were under contract with NCI to "conduct late-stage clinical testing, and to manufacture and market the drug."〔
==History==
In August 2015 United Therapeutics sold its pediatric-rare disease FDA priority review voucher that it had received for the development of Unituxin to AbbVie for $350 million.〔 According to Forbes journalist Tim Worstall, a "lucrative secondary market" emerged by 2015 in the form of vouchers that "require the FDA to shorten its decision deadline to six months from the standard 10 months—potentially giving companies an extra four months’ worth of sales. The voucher doesn’t guarantee the FDA will approve the drug."

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
ウィキペディアで「Dinutuximab」の詳細全文を読む



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