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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.
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Semaglutide Retinopathy Risk No Bar To Approval, US Panel Says

Novo Nordisk's once-weekly GLP-1 agonist can address diabetic retinopathy complications through labeling, US FDA advisory committee says in endorsing approval; panelists say a postmarketing study on retinopathy would be desirable and could be folded into a larger cardiovascular outcomes trial.

Advisory Committees Drug Review

Novo's Semaglutide: Retinopathy Events Will Draw US FDA Panel's Focus

Once-weekly GLP-1 agonist was associated with higher risk of diabetic retinopathy complications in the SUSTAIN-6 trial, but Novo says this is consistent with data on early worsening of pre-existing retinopathy after glycemic control improves. While FDA's ophthalmology consultant concludes there's no cause for worry, clinical review team expresses 'residual concerns.'

Advisory Committees Drug Review

How To Build An Endpoint: Spark Designed Testing Maze To Study Rare Vision Loss

In an interview, Spark President Katherine High explains that multi-luminance mobility test used in clinical development of Spark's gene therapy voretigene sprang from 2011 FDA meeting on need to study functional vision in patients with retinal degenerative diseases. Experience highlights need for new endpoints when targeting previously untreated diseases, she says.

Advisory Committees Drug Review

Spark's Gene Therapy Luxturna Sails Through US FDA Panel

Improvements seen in multi-luminance mobility testing in the voretigene Phase III trial were clinically meaningful, panelists said, endorsing the novel endpoint for the vision loss treatment. They also were persuaded by first-hand accounts from patients.

Advisory Committees Drug Review

Spark's Vision Loss Gene Therapy Raises US FDA Questions About Novel Endpoint

Multi-luminance mobility testing was developed by firm to measure functional vision across a range of lighting levels in patients with RPE65 mutations; advisory committee also will consider minimum patient age and clinical stage of disease appropriate for subretinal injections with voretigene.

Advisory Committees Drug Review

PCSK9 Patent Case: Praluent Injunction Vacated, But May Well Return

Appeals court vacates injunction that Repatha marketer Amgen had won against Sanofi/Regeneron's Praluent, but notes 'a reduction in choice of drugs cannot be the sole reason for a district court to deny an injunction.'

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