For Novartis execs, the old cliche that ‘if it’s not one thing, it’s another,’ is becoming quite true. For the past year, the drugmaker has struggled to get a handle on manufacturing problems at several plants around the world, which have attracted scrutiny from regulators. The latest mishap occurred in Rosia, Italy, where a data-handling discrepancy caused some vaccines to be temporarily and voluntarily held for several months. The drugmaker undertook a so-called good manufacturing practice, or GMP, investigation and reported the findings to the European Medicines Agency and the Agenxia Italiana del Farmaco before shipments resumed two months ago, a Novartis spokesman confirms.
