Drug Industry Daily

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The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 9–6 Thursday to recommend approval of Genzyme and Isis Pharmaceuticals’ homozygous familial hypercholesterolemia (HoFH) drug Kynamro.

The FDA has extended the PDUFA date for Biogen Idec’s multiple sclerosis (MS) treatment BG-12 by three months to March 28, 2013.

The FDA has approved ThromboGenics’ Jetrea injection as the first drug to treat symptomatic vitreomacular adhesion (VMA).

Ben Venue’s Bedford, Ohio plant — in the news this past year for quality problems — has restarted a handful of production lines to make some of its critical-need drugs available again.

The FDA has approved Eli Lilly’s Alimta for use as a single agent for continuous maintenance treatment of nonsquamous non-small cell lung cancer (NS NSCLC) based on new clinical data.