Drug Industry Daily

View the entire issue.

Despite liver toxicity concerns, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13–2 to recommend approval of Aegerion Pharmaceuticals’ lomitapide.

FDA investigators and local police Tuesday raided the Framingham, Mass., facilities of the compounding pharmacy whose steroid injections are linked to a recent fungal meningitis outbreak.

Pfizer’s advanced kidney cancer drug Inlyta missed its primary endpoint in a late-stage trial of treatment-naïve patients, leaving the company’s hopes for a first-line indication in doubt.

The FTC tentatively approved Watson Pharmaceuticals’ acquisition of Actavis, provided Watson transfers rights to 18 drugs to Sandoz and Par Pharmaceuticals and relinquishes manufacturing and marketing rights to three other products involved in the sale.