Drug Industry Daily

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An FDA advisory panel voted 12–0 Tuesday to recommend approval of NPS Pharmaceuticals’ Gattex as a treatment for short bowel syndrome (SBS).

Johnson & Johnson’s subsidiary Janssen Products has reinstated unrestricted access to its cancer drug Doxil, releasing the remainder of its reserve after working through a shortage.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Thursday will discuss a number of liver-related and carcinogenic adverse events seen in four Phase III trials of Genzyme and Isis Pharmaceuticals’ Kynamro as a treatment for homozygous familial hypercholesterolemia (HoFH), a life-threatening genetic disorder.

The FDA has granted a priority review to Genentech’s sBLA for Avastin in people with metastatic colorectal cancer (mCRC) who have already been treated with chemotherapy plus Avastin. The agency aims to finish its review by Feb. 5.