10 September 2010
Keywords: Ceftobiprole, Johnson & Johnson, Basilea, Janssen Cilag, CHMP, MRSA
Article | 12 March 2010
Janssen-Cilag International NV, a subsidiary of US health care giant Johnson & Johnson, has submitted a request for re-examination of the negative opinion issued on February 18 by the European Committee for Medicinal Products for Human Use (CHMP) on the Marketing Authorization Application (MAA) for Zeftera (ceftobiprole) for the treatment of complicated skin and soft tissue infections (cSSTI).
The negative European regulatory opinion on ceftobiprole led Janssen-Cilag to return rights to the product they had been jointly developing over the past five years to originator Switzerland-based Basilea (The Pharma Letter February 22). Enjoying this article? To continue reading you need to login, take a FREE trial or subscribe.
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