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Sue Sutter

Senior Editor

Washington, DC
Sue primarily covers US drug, biologic, vaccine and biosimilar regulation and policy across therapeutic areas, with an emphasis on advisory committee reviews, FDA approvals and use of expedited review pathways. Sue has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the Citeline umbrella, including Pink 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. She grew up in South Jersey and spends her free time watching youth sports, gardening, walking and hiking, although she'd rather be at the beach.

Latest From Sue Sutter

COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

Coronavirus COVID-19 Vaccines

Advisory Committee Consumer Reps Often Fail To Represent Consumer Interests, Groups Tell US FDA

Many positions are vacant or filled by individuals with ties to academia, industry or patient groups, representatives from public interest and consumer groups say during an FDA listening session on advisory committee reforms.

Advisory Committees FDA

US FDA’s Cell-Gene Therapy Office Head Wants Sponsors To Seek Out Meetings

Companies should talk to FDA staff in between formal meetings if they need clarity on agency advice that is several years old or development programs hit a snag, Office of Therapeutic Products Director Nicole Verdun says.

Gene Therapy Clinical Trials

Anti-Amyloid Class Labeling Could See Changes With Lilly’s Donanemab Approval

The US FDA is considering labeling that calls greater attention to the symptoms of amyloid-related imaging abnormalities to ensure proper treatment and avoid misclassification as ischemic stroke.

Advisory Committees Drug Review

Lilly’s Donanemab Set For Broad Indication, No Tau PET Imaging Condition Following US FDA Panel Nod

The advisory committee also hails the treatment-to-amyloid clearance approach used in the Phase III trial as innovative, but questions how it should apply in clinical practice.

Advisory Committees Neurology

Project Orbis, 'Cluster' Calls Validate Global Regulators’ Drug Application Concerns

Regulators from the US, Canada, European Union, Switzerland and Japan talk about the benefits of global collaboration, and reasons why they might reach different decisions on the same drug, at the American Society of Clinical Oncology annual meeting.

Drug Review Regional Comparisons
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