Steve Duffy

Digital Content Editor

Most Recent Articles by Steve Duffy

Revefenacin Cuts COPD Exacerbation Rates in Phase 3 Studies

Revefenacin Cuts COPD Exacerbation Rates in Phase 3 Studies

By

Pooled data from two identical 12-week pivotal Phase 3 trials (N=1229) in patients with moderate to very severe COPD showed that the mean annualized rate of all COPD exacerbations was 0.47, 0.45, and 0.55 for revefenacin 175mcg/day, 88mcg/day, and placebo, respectively.

FDA Fast-Tracks Pamrevlumab for Idiopathic Pulmonary Fibrosis

FDA Fast-Tracks Pamrevlumab for Idiopathic Pulmonary Fibrosis

By

The FDA's designation was based on data from a Phase 2 placebo-controlled trial that demonstrated pamrevlumab could potentially address an unmet medical need for this condition.

Positive Results for Zerbaxa in Phase 3 Study of Ventilated HABP, VABP Patients

Positive Results for Zerbaxa in Phase 3 Study of Ventilated HABP, VABP Patients

By

The full findings from the study will be presented at a future scientific conference; Merck plans to include the data in a supplemental New Drug Application for Zerbaxa which will be submitted to the Food and Drug Administration.

FDA: More Data Required to Support Mepolizumab Approval for COPD

FDA: More Data Required to Support Mepolizumab Approval for COPD

By

In their Complete Response Letter, the FDA stated that they require more clinical data to support approval.

AAP Issues Updated Influenza Vaccine Recommendations

AAP Issues Updated Influenza Vaccine Recommendations

By

According to the Centers for Disease Control and Prevention (CDC), the 2017-2018 flu season was one of the most severe - excluding pandemics - on record.

More Articles by Steve Duffy

Sign Up for Free e-newsletters