Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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

US FDA’s Genetic Metabolic Diseases Adcomm Debuts With Zevra’s Arimoclomol

The new panel’s inaugural 2 August meeting will take up a challenging drug application, currently in its second review cycle, for Niemann-Pick disease type C, an ultra-rare condition without approved therapeutics.

Advisory Committees Rare Diseases

Lilly’s Kisunla Postmarketing Studies Include Maintenance Dosing, But No Safety Trial

Lilly must conduct registry-based and retrospective cohort studies, similar to those required for Eisai/Biogen’s Leqembi, to assess the risks of ARIA and intracerebral hemorrhage with donanemab, but there is no additional requirement for a safety-focused clinical trial.

Approvals Clinical Trials

US FDA Advisory Committee Open Public Hearing Changes Urged

Patients want more attention paid to their experiences with an investigational drug, while consumer groups and academics say those who were harmed also should be heard.

Advisory Committees FDA

Lilly’s Kisunla: Labeling Allows For Stopping Treatment Based On Amyloid Plaque Reduction

However, the US FDA’s approval of donanemab comes with little guidance on when to stop treatment or when the anti-amyloid agent may need to be restarted in Alzheimer’s patients.

Approvals Neurology

Deference No More: More Challenges Against US FDA After Supreme Court Tosses Chevron Doctrine?

The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

Legal Issues FDA

Deference No More: More Suits Against US FDA Coming After High Court Tosses Chevron Doctrine?

The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

Legal Issues FDA
See All
UsernamePublicRestriction

Register