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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

PhRMA Adds Genentech, Gilead To Its Ranks Ahead Of House Democrats’ Drug Pricing Scrutiny

Roche, through Genentech, returns to the PhRMA fold after leaving the trade group in 2009; Gilead is a first-time member; both are retaining their BIO memberships as well.

Pricing Debate Research and Development Strategies

Can A REMS Mitigate CV Risks? Avandia, Meridia Offer Point, Counterpoint

As US FDA weighs fate of Takeda’s febuxostat, advisory committee members suggest REMS to ensure prescribers have informed benefit/risk conversation with patients, but agency staff highlight design and assessment challenges for such a program.

Advisory Committees Drug Safety

Is There A REMS In Uloric’s Future? US FDA Panelists Say Yes, Agency Says Not Likely

Continued availability of Takeda’s febuxostat should be restricted to second-line use in gout patients who cannot tolerate or fail allopurinol, advisory committee majority says, opposing market withdrawal; but panelists’ suggestion that a Risk Evaluation and Mitigation Strategy be put in place to ensure patients and prescribers discuss cardiovascular risks receives pushback from agency.

Advisory Committees Drug Safety

US FDA's Biosimilars Chief Leah Christl Plans Departure

A departure date has yet to be determined for the associate director of therapeutic biologics, who helped negotiate and implement the biosimilar user fee program.
Biosimilars FDA

Takeda’s Uloric: CV Mortality Signal Leads US FDA To Ponder Regulatory Options

Advisory committee will discuss whether CARES postmarketing trial showing 34% increased risk of cardiovascular death for febuxostat warrants market withdrawal, use restrictions, or new labeling for the gout drug.

Advisory Committees Drug Safety

J.P. Morgan Notebook Day 2: Biogen, GSK, Bluebird, Roche, Amgen, Biohaven, Lilly And FDA's Gottlieb

Daily round-up of news and notes from the 2019 J.P. Morgan Healthcare Conference in San Francisco: Biogen may be looking for gene therapy partner, Lilly CEO says Loxo is just the start, GSK plays up its BCMA, Amgen vows to put money into deals, Biohaven readies oral CGRP inhibitor to compete, and Roche talks value-based payments. 

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