FDA to use leading indicators to get ahead of drug quality lapses; Mapi Pharma gets patent for generic Gilenya;

> Janet Woodcock, FDA director of CDER, says the agency intends to develop leading indicators that can help it get out in front of manufacturing and quality issues on drugs. Story

> Another company is being formed in the U.S. with its eye on making products for the sterile injectable drug market, an area where quality issues have resulted in lots of shortages. Report

> CMO Cytovance Biologics has a new agreement to develop a cell line and for the GMP manufacturing of Phase I clinical material for Pamlico Biopharma. Release

> Two Turkish nationals have been arraigned on charges of smuggling illegal cancer drugs into the U.S. Release

And Finally... Israel's Mapi Pharma says it has been granted a patent covering the process for the preparation of Fingolimod, a generic of Novartis' ($NVS) Gilenya. Release