Santarus and Pharming Announce Special Protocol Assessment Agreement with FDA for RHUCIN Phase III Clinical Study

Symbols: SNTS
Posted in: News, FDA
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Santarus, Inc. (NASDAQ: SNTS) and biotech company Pharming Group NV earlier today announced that they have reached agreement with the U.S. Food and Drug Administration on the design of a Phase III clinical study with the investigational drug RHUCIN® (recombinant human C1 inhibitor) under the Special Protocol Assessment process that is intended to support the submission of a Biologics License Application.


 
 
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