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Sue Sutter

Senior Editor

Washington, D.C.
Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.  She has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the umbrella of Informa Business Information, including Pink Sheet, “The Pink Sheet” DAILY, “The Tan Sheet” and Scrip.  Previously she worked as an editor for Mealey’s Litigation Reports (now part of Lexis-Nexis), writing about asbestos, toxic tort and fen-phen litigation.

Latest From Sue Sutter

US FDA's Ebola Drug Approvals Showcase Efficiencies With Master Protocols

Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.

Drug Review Profile Approvals

Inmazeb Brought Regeneron A Priority Review Voucher, But Not The Type It Wanted

Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.

Drug Review Profile Approvals

Regeneron's Inmazeb Overcame FDA Combo Product Requirements With Nonclinical Evidence

The individual contribution of the three mABs in Regeneron’s Ebola treatment could not be clinically tested due to the highly lethal nature of the disease and the potential for development of resistance; instead, the FDA accepted nonclinical data demonstrating the mechanism of action for each component.

Drug Review Profile Approvals

Inmazeb Clinical Development Timeline

Chronicle of the development and review of Regeneron’s REGN-EB3, a triple mAB combination treatment for Ebola infection.

Drug Review Profile Approvals

Ebanga Clinical Development Timeline

Chronicle of the development and review of Ridgeback Biotherapeutics’ ansuvimab-zykl for treatment of Ebola infection.

Drug Review Profile Approvals

J&J's COVID-19 Vaccine May Face Efficacy Comparison Questions At US FDA Panel Review

Efficacy against moderate to severe/critical COVID-19 was 66%-67%, well above the FDA’s stated 50% efficacy threshold for an EUA but far short of the 94%+ efficacy rates posted by the Pfizer and Moderna vaccines against symptomatic disease; agency says efficacy against specific variants cannot be evaluated at this time because sequencing data are incomplete.

Advisory Committees Vaccines
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