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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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Latest From Sue Sutter

Amarin Heads Into Vascepa Expansion Labeling Talks After Positive US FDA Panel Review

Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory committee members favored a broad claim for secondary and primary prevention reflecting the REDUCE-IT trial population, but some strongly opposed an indication that includes patients without established CV disease.

Advisory Committees Drug Review

Amarin’s Vascepa Positioned For Broad CV Risk Reduction Claim Following US FDA Panel Nod

Despite FDA's concerns, advisory committee unanimously endorses Vascepa's labeling expansion, with 10 of 16 members also favoring approval for secondary as well as primary prevention even as several voiced misgivings about efficacy in the REDUCE-IT trial's lower risk cohort.


Advisory Committees Drug Review

Amarin’s Vascepa: US FDA Panel To Scrutinize Breadth Of CV Risk Reduction

REDUCE-IT enrolled a higher risk group than the broad population targeted by Amarin’s proposed indication statement, agency says; although reviewers conclude an interaction between the mineral oil placebo and statins cannot be excluded, any impact would have been small and unlikely to change overall treatment effect.

Advisory Committees Drug Review

US FDA Revokes Orphan Drug Designation For Indivior’s Sublocade

In first-of-its-kind decision, agency concludes it relied on unreasonable assumptions regarding total market size, and failed to consider information about other dosage formulations, in granting designation for buprenorphine under the cost recovery provision; however, the FDA reaffirms that scope of Sublocade’s three-year exclusivity will keep Braeburn’s Brixadi off the market for another year.

Legal Issues FDA

Postmarketing Safety: US FDA ‘Best Practices’ Include Weekly Adverse Event Screening For New Drugs

Agency’s approach to risk-based postmarketing safety surveillance explained in new draft document issued under the 21st Century Cures Act; product characteristics and intended use guide the frequency and extent of adverse event report screening, with newer drugs undergoing weekly reviews for three years after approval.

Drug Safety Biosimilars

Are US Interchangeability Studies Worth It?

Payers are driving the selection of reference products or biosimilars, creating an ‘artificial interchangeability’ unlikely to be affected by the actual regulatory designation, industry reps say; former FDA commissioner Scott Gottlieb says misinformation campaigns around biosimilar and interchangeable products may lead to enforcement by the FDA and Federal Trade Commission.

Biosimilars Business Strategies
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