Durata Looks Beyond FDA: Reimbursement Changes May Offer Opening for Long-Acting Anti-infective

Is the FDA regulatory climate getting better for anti-infective development? One clear “yes” emerges from the approach being taken by Durata Therapeutics in a series of recent investor presentations: Durata is focusing beyond FDA on the next challenge – finding the right commercial opening for long-acting anti-infectives.

Durata Therapeutics Inc. is sending a message on the improving regulatory environment for anti-infectives at the Food & Drug Administration by what it is not telling Wall Street.

The company is not focusing on the hurdle posed by FDA approval for its second-generation IV lipoglycopeptide antibiotic, dalbavancin, and...

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