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


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.
Set Alert for Articles By Sue Sutter

Latest From Sue Sutter

Bronchiectasis Trials Should Be Longer, Focus On Exacerbation Frequency

Bayer's endpoint for Phase III trials of ciprofloxacin inhaler should have focused on frequency of, rather than delay in, exacerbations, US FDA advisory committee members say; Aradigm's pending NDA in non-cystic fibrosis bronchiectasis could be impacted recommendations on endpoints, trial duration and concerns about long-term development of antibiotic resistance.

Advisory Committees Drug Review

Bayer's Inhaled Cipro Cannot Surmount Inconsistent Efficacy Data At US FDA Panel

Advisory committee recommends against approval of dry powder formulation for treating non-cystic fibrosis bronchiectasis due to inconsistent results in Phase III RESPIRE trials and concerns about long-term benefit and antibiotic resistance.

Advisory Committees Drug Review

Bayer's Inhaled Cipro For Bronchiectasis To Face FDA Panel Efficacy Questions

Advisory committee asked to opine on whether there is substantial evidence of efficacy even though Phase III studies missed on three of four primary efficacy measures; Bayer argues that totality of the evidence demonstrates a meaningful benefit in reducing exacerbations in a heterogeneous patient population with the rare disease.

Advisory Committees Drug Review

Heplisav-B Approval Has Dynavax Going It Alone On US Launch In Early 2018

Hepatitis B vaccine's favorable efficacy data relative to GSK's Engerix-B and neutral safety language mean that any partnership opportunity 'would need to be a highly attractive one to alter our current course,' Dynavax CEO Gray says.

Approvals Launches

Dynavax's Hep B Vaccine Finally Clears US FDA With Clean Label But Larger Safety Study

Heplisav-B labeling notes myocardial infarction imbalance in one trial but also apparent absence of a causal relationship; sponsor will conduct a postmarketing safety cohort study involving 50,000 subjects, 10,000 more than initially planned.

Approvals Vaccines

FDA Prioritizes ANDAs Ready For Launch After 180-Day Exclusivity Expires

In effort to speed competition and lower drug prices, US regulator will prioritize review of generic drug applications likely to be ready for approval on or shortly after the expiration of first-filer's exclusivity; experts say the move appears to formalize what once had been an informal Office of Generic Drugs policy.

Generic Drugs Pricing Debate
See All