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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

Accelerated Approval: Nippon Shinyaku’s Viltepso Fails DMD Confirmatory Trial, Raising Questions

The Duchenne muscular dystrophy treatment missed its primary endpoint of time to stand from supine in the RACER53 study, raising more questions about using dystrophin changes to support accelerated approval and the ability of functional endpoints to detect clinical change.

Post Market Regulation & Studies Rare Diseases

Weight Loss, Diabetes Treatments Focus Of FTC's Second Round Of Patent Listing Challenges

We take a deep dive into the Federal Trade Commission's second wave of challenges to patents it asserts are improperly listed in the FDA's Orange Book, including patents covering Novo Nordisk's self-injection pens for Saxenda (liraglutide) and Ozempic (semaglutide).

Intellectual Property Pricing Debate

Novo’s Insulin Icodec Hypoglycemia Risk Outweighs Limited Benefit In Type 1 Diabetes–FDA Panel

The Endocrinologic and Metabolic Drugs Advisory Committee majority says new studies should validate the proposed risk mitigation measures before approval for T1D.

Advisory Committees Drug Review

Novo’s Insulin Icodec: Hypoglycemia Events In Type 1 Diabetics Put Broad Indication At Risk

A US FDA advisory committee will consider whether the benefits of once-weekly insulin icodec outweigh the significantly higher rate of hypoglycemic episodes in patients with type 1 disease. The agency appears satisfied with safety and efficacy in type 2 diabetics.

Advisory Committees Drug Review

Weight Loss, Diabetes Treatments Focus Of FTC's Second Round Of Patent Listing Challenges

The Pink Sheet takes a deep dive into the Federal Trade Commission's second wave of challenges to patents it asserts are improperly listed in the FDA's Orange Book, including patents covering Novo Nordisk's self-injection pens for Saxenda (liraglutide) and Ozempic (semaglutide).

Intellectual Property Pricing Debate

‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches

The current regulations were written when clinical trials involved far fewer entities, and a certain amount of ‘contortion’ is necessary when sponsors are trying to introduce decentralized, community-based and other modern elements, the FDA’s Kevin Bugin says in an interview with the Pink Sheet.

Clinical Trials Diversity & Inclusion
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