12:00 AM
Dec 09, 2013
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Ceftolozane/tazobactam: Phase III data

Cubist expects to report top-line data late this month from a pair of Phase III trials evaluating ceftolozane/tazobactam to treat complicated intra-abdominal infections (cIAI). Cubist plans to submit an NDA to FDA in 1H14 and an MAA to EMA "shortly thereafter" for ceftolozane/tazobactam to treat both cUTI and cIAI. Cubist also plans to start a Phase III trial with ceftolozane/tazobactam to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) in 1H14.

The product has Qualified Infectious Disease Products (QIDP)...

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