Washington Drug Letter

Generic-drug makers, including those with backlogged ANDAs and companies submitting prior approval supplements (PASs) and drug master files (DMFs), will know how much user fee money they’ll have to dole out to the FDA in fiscal 2013 by the end of October.

Drugmakers operating in the Third Circuit Court of Appeals jurisdiction will need to remain cautious about engaging in reverse patent settlements as the court refused to put on hold its recent ruling that such deals are anticompetitive while Merck and Upsher-Smith appeal to the Supreme Court.

In a victory for the biotechnology industry, the U.S. Court of Appeals for the Federal Circuit ruled 2–1 to reaffirm its earlier ruling that Myriad Genetics can patent genes related to its breast and ovarian cancer screening system.

Generic drugmakers have until Sept. 28 to either withdraw pending ANDAs or face a backlog fee, the FDA says.

Bayer Pharma AG has filed a lawsuit against Warner Chilcott in the U.S. District Court of Delaware, alleging that Warner’s oral contraceptive Lo Loestrin FE infringes on a Bayer patent.

Apparently assured of U.S. and EU approval for Lemtrada in relapsing multiple sclerosis (MS), Genzyme is pulling its leukemia drug Campath, which has the same active ingredient, so Lemtrada can better compete in the MS space.

The FDA has approved a new indication for Boehringer Ingelheim and Eli Lilly’s Tradjenta as an add-on therapy to insulin in Type 2 diabetes.

Sponsors of new drugs seeking approval with a companion in vitro diagnostic (IVD) need to work with trial sites to ensure they are not prescreening patients by local test methods — a process that can prove fatal for regulatory approval, an expert says.

Hospira is recalling another lot of hydromorphone HCl injection after receiving fresh reports of overfills in the syringe-based drug delivery system.

Significant deviations from good manufacturing practices (GMP) at India’s Claris Lifesciences and Spain’s Moehs Iberica S.L. appear to be resolved as both companies received closeout letters from the FDA.