Article by PharmExec’s Clark Herman on the 505(b)(2) pathway for drug approval
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Aris Persidis, president and co-founder of Biovista, a company focused on the 505(b)(2), adds, “In addition, the first to file patent regulations that will take effect in the US next year are making companies realize that they may be susceptible to competitors repositioning their own drugs. This, plus the patent cliff and the cost and risk reductions, are some of the key reasons behind the 505(b)(2) increase and interest in drug repositioning as a whole.”
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