Genmab — Juni 2017
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"One example is a cancer where a drug targets a particular molecular subset, regardless of where the tumor arises. We`ll clarify when we can give broad approval to a drug in multiple different kinda of molecularli-similar cancers which are not particular to the tumor being in one specific tissue or organ" Gottlieb said.
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FDA to Clear Path for Drugs Aimed at Cancer-Causing Genes (1)
Now, in a long-awaited move, U.S. drug regulators will simplify the approval of treatments targeting specific gene mutations that can spur tumors in a variety of organs. The Food and Drug Administration will soon announce a plan to update agency policies and facilitate the approval of critically needed drugs, including so-called “tumor-agnostic” therapies that target cancer-linked DNA, according to FDA Commissioner Scott Gottlieb. “The most tangible way we’re going to reduce health-care costs is by finding better treatments for a lot of costly diseases,” Gottlieb told the Senate panel responsible for overseeing the agency’s budget on Tuesday.
Yahoo Finance (sg.finance.yahoo.com)
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Link til Bikubes citat: http://www.borderless.net/gottliebs-fda-to-rethink-targeted-therapy-regulation/
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Tæsk til SGEN trods de positive fase 3 resultater (som bare ikke viste så stor separation mellem test og kontrol arm) - nu er de snart nødt til at satse på Tisotumab
https://www.fool.com/investing/2017/06/26/why-shares-of-seattle-genetics-inc-got-whacked-tod.aspx?yptr=yahoo
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