Novartis Begins to Fix Manufacturing Problems
For more than a year, Novartis (NVS) has been plagued with manufacturing problems at various plants in different countries, prompting managerial shake-ups and a crisis in confidence that led ceo Joe Jiminez to insist that quality matters (see Pharma news). And late last week, the drugmaker was able to boast that signs of a turnaround are finally emerging.
The first bit of good news came when the Italian Medicines Agency announced that a temporary halt on the use of the Agrippal and Fluad flu vaccines was lifted (here is the Novartis statement). This was an important development for Novartis, because the vaccines are made in Italy and several other countries quickly followed Italy earlier this month to suspend usage.
This was the second time, in fact, that Novartis experienced a problem with vaccines made in Rosaria, Italy, where a data-handling discrepancy earlier this year caused some vaccines to be temporarily and voluntarily held for several months. The latest problem involved small particles found in the vaccines.
The other encouraging development occurred when the FDA indicated that the Sandoz manufacturing plant Broomfield, Colorado, which was one of three sites referenced in a November 2011 warning letter, had finally achieved positive compliance status following a re-inspection in August, a Novartis spokeswoman confirms.
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Ed Silverman is the editor of Pharmalot and a contributor to YCharts, which includes the just-released YCharts Pro Platinum for professional investors.