Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Advertisement
Set Alert for Articles By Sue Sutter

Latest From Sue Sutter

Pfizer's Infliximab Biosimilar Approved In US But Won't Launch Against Inflectra

Ixifi (infliximab-qbtx), which references Janssen's Remicade, marks first US approval of a biosimilar developed entirely by Pfizer; big pharma says it is not currently planning to launch Ixifi because it remains "committed" to marketing Celltrion's Inflectra.

Approvals Biosimilars

Minimal Residual Disease 'Coming Soon' As An Approval Endpoint, Celgene Says

Celgene's ASH briefing notes 'unprecedented' MRD-negative data in Phase I study in multiple myeloma development program for CAR-T therapy bb2121; firm sees potential opportunity for the marker to pave way for approval in earlier-line settings of the disease.

Drug Approval Standards Review Pathway

Drug Pricing: US Senate Hearings Conclude With No Clear View On Legislation

Measures that would increase financial transparency and empower federal government to negotiate drug prices highlighted by National Academies representative who discussed recent report on drug affordability, but former Congressional Budget Office Director Holtz-Eakin warns Senate HELP Committee against taking measures that merely shift costs from one party to another.

Pricing Debate Pharmacy Benefit Management

FDA May Clarify When Responsibility Prompts Park Doctrine Prosecutions

FDA is considering whether a breach of duty to act or correct violations under the FDCA must occur before criminal charges are brought, Chief Counsel Rebecca Wood says. Clarity on FDA's view of 'vicarious criminal liability' would be welcome news to the pharma industry and suggests an early priority for the agency's new top lawyer.

United States Dietary Supplements

Sanofi's Admelog, a Humalog Follow-On, Approved In US As 'Black Hole' For Insulins Looms

Short-acting insulin approved under 505(b)(2) pathway appears poised to receive three years of Hatch-Waxman exclusivity but would lose nine months of this protection under FDA's current interpretation of the 'transition provisions' for certain protein products that take effect in March 2020.

Approvals Biologics

Bladder Pain, Interstitial Cystitis And The Move Toward Patient-Focused Drug Development

Patients with the conditions experience the same symptoms, US FDA advisory committee concludes. Industry sponsors had advocated for combined trials, but panel did not agree with firms' recommendations on study duration and outcome measures.

Advisory Committees Clinical Trials
See All
Advertisement
UsernamePublicRestriction

Register