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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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Neratinib’s FDA Panel Nod Weighed Down By Indication Breadth Worries

Puma’s tyrosine kinase inhibitor gains recommendation from US advisory committee but faces concerns that proposed indication for extended adjuvant treatment in HER2-positve breast cancer is overly broad given unfavorable subgroup results in pivotal trial.

Advisory Committees Drug Review

US FDA Urged To Rethink Warning Letters To Avoid ‘Collateral Damage’

Industry attorneys worry US agency is not considering late responses to adverse inspection reports before issuing warnings, and that letters sometimes go beyond the recommendations laid out in existing FDA guidance

Compliance Manufacturing

Puma’s Neratinib Brings Uncertain Efficacy, Tolerability Concerns To FDA Panel

Tyrosine kinase inhibitor has an effect in adjuvant breast cancer but ‘there remains some uncertainty regarding the true magnitude of the treatment effect,” FDA reviewers say; given incidence and severity of diarrhea, experts will be asked to consider whether there is a subpopulation with a more favorable risk/benefit profile.

Advisory Committees Drug Review

Sarepta Protocol Changes Could Impact Future Duchenne Trials

If US FDA Commissioner Gottlieb allows use of in-dwelling ports in ESSENCE study, Office of Pediatric Therapeutics will assess whether the determination could serve as precedent for placebo-controlled trials of other exon-skipping compounds in Duchenne muscular dystrophy.

Advisory Committees Clinical Trials

Sarepta’s ESSENCE Trial Gets FDA Panel Nod For Protocol Changes

US agency’s experts unanimously support allowing use of in-dwelling ports to aid infusions in trial of two Duchenne muscular dystrophy compounds, while also endorsing the two-year, double-blind, placebo-controlled design, which was influenced by the clinical experience with Exondys 51 (eteplirsen).

Advisory Committees Pediatrics

Drug Promotion: Exclusivity Warrants Narrow Exception From Free Speech Protections

AbbVie and Daiichi tell US FDA that manufacturers’ communications should not be considered protected speech if they infringe exclusivity rights of other companies; comments seem aimed at restricting what competitors can say about protected claims for Humira and MorphaBond.

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