Nov. 2, 2012 | Vol. 11 No. 216 | Full Issue in PDF Format
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Rep. Ed Markey (D-Mass.) plans to introduce a bill Friday that would force larger-volume compounders to register with the FDA as drug manufacturers.
The FDA has shot down Cornerstone Therapeutics’ low-sodium drug lixivaptan for both its proposed indications.
An FDA advisory panel is meeting Friday to make a recommendation on GlaxoSmithKline’s (GSK) anti-anthrax drug raxibacumab.
Pfizer’s third-quarter profit declined 14 percent from the same quarter last year, largely due to loss of exclusivity on its cholesterol-lowering blockbuster Lipitor and schizophrenia drug Geodon.
Teva Pharmaceuticals has resolved a long-outstanding warning letter for its Irvine, Calif., plant, the company said on its third-quarter earnings call Thursday.
Vertex plans to work separately with both GlaxoSmithKline (GSK) and Johnson & Johnson’s Janssen on studies of an all-oral therapy for treating hepatitis C using Vertex’s polymerase inhibitor VX-135.
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