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Aducanumab Review: Looking For Precedents – Long Ago And Far Afield

Executive Summary

The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.

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Aducanumab Fall-Out: An Inexpedient Use Of ‘Expedited’ Review

The aducanumab review involved everything sponsors might think they could want from the US FDA, with the agency taking a hands on approach to expedite a complex and difficult review in hopes of delivering an important new therapy to patients as quickly as possible. Unfortunately, in this case, FDA seems to have expedited the review right over a cliff.

Actavis’ Avycaz Approval Shows How FDA Handles Limited-Data, Limited-Use Antibiotic

FDA grants approval to two of three indications for gram-negative antibiotic based on Phase II data but follows its advisors in rejecting a third indication that came without human data, offering hints of what the limitations and possibilities of a formal limited population antibiotic approval pathway might look like.

Two Steps Forward, One Step Back: FDA, Actavis Antibiotic Plan Goes A Bit Too Far For Committee

FDA continues to reshape the antibiotic regulatory pathway, both in word and in deed. The latest example of a collaborative, push-the-envelope review included a novel Actavis antibiotic formulation where FDA seemed ready to approve the drug without any human data. That was one step too far for the agency’s advisors.

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