The FDA lifted its import ban on a generic drug facility run by Canadian company Apotex. The decision means the firm can resume shipments of oral solid dose products from the Toronto facility, its largest manufacturing facility supplying those products to the US, the company said. Apotex said it will manufacturing and shipping will resume immediately. The agency had placed a restriction on Apotex US exports last spring, after finding “significant violations” of Current Good Manufacturing Practice (CGMP) regulations, and contamination in equipment at the Toronto plant.
InVentiv Health is buying contract research organization (CRO) PharmaNet Development Group. With the acquisition – the firm's second CRO investment since January – inVentiv hopes to bolster its communications and consulting offerings to drug and device companies. Financial information on the transaction, which is expected to close by the second quarter, was not disclosed. Estimated to be worth $21 billion globally, the CRO market is projected to grow annually by 7% through 2014, with scale expected to remain a key factor in winning new business. The add-on extends inVentiv's global reach to nearly 40 countries and bolsters its early- and late-stage clinical development capabilities, the company said.