June 25, 2012 | Vol. 11 No. 124 | Full Issue in PDF Format
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The FDA has given Johnson & Johnson (J&J) a complete response letter for its sNDA on the blood-clot drug Xarelto following a narrow advisory committee rejection last month.
Roche subsidiary Genentech’s breast cancer treatment Perjeta extended patients’ lives in a key clinical trial — another boost for the drug, which received FDA approval earlier this month.
Watson has received an untitled letter for a journal advertisement for iron deficiency anemia drug Nulecit that shows impacts on parallel therapies that are not representative of clinical trial results.
Trial sponsors should still include key documents that provide critical study information, such as the protocol and statistical methods, in the clinical study report (CSR) even though those documents are now available in the Trial Master File (TMF), according to a new question-and-answer document on the International Conference on Harmonisation (ICH) E3 guidance.
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