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Sue Sutter

Senior Editor

Washington, DC
Sue primarily covers US drug, biologic, vaccine and biosimilar regulation and policy across therapeutic areas, with an emphasis on advisory committee reviews, FDA approvals and use of expedited review pathways. Sue has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the Citeline umbrella, including Pink 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. She grew up in South Jersey and spends her free time watching youth sports, gardening, walking and hiking, although she'd rather be at the beach.

Latest From Sue Sutter

GSK’s Blenrep: 15 Days From Confirmatory Trial Failure To Withdrawal Announcement

The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.

Review Pathway Post Market Regulation & Studies

Clinical Trial Diversity Would Benefit From Regulatory, Financial Incentives, Experts Say

Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.

Clinical Trials Diversity & Inclusion

N Of 2: Reflections On The Makena, Avastin Accelerated Approval Withdrawal Hearings

Despite major differences in the sponsors, drugs and circumstances, the outcomes from the hearings on Makena’s continued availability and Avastin’s breast cancer indication were strikingly similar, with overwhelming votes in favor of withdrawal. In the process, however, both sponsors gained extra commercial time for their products.

Outlook 2023 Review Pathway

Exit Interview: US FDA’s Sandra Kweder Reflects On A 30-Year Career As She Heads Into Retirement

Having recently returned from six years overseas as the FDA’s liaison to the European Medicines Agency, ‘now was a good time to try something different,’ Kweder says in a Pink Sheet interview. Her tenure at the agency included numerous leadership roles in CDER as well as spearheading the development of the pregnancy labeling rule.

FDA Leadership

Dispute Resolved? Ardelyx’s Tenapanor Gets US FDA Panel Nod For Dialysis Patients

Tenapanor could be an option for dialysis patients who cannot tolerate phosphate binder therapy or who need more help in reaching their serum phosphorous targets, advisory committee members said; Office of New Drugs director Peter Stein is expected to rule on Ardelyx’s appeal of a complete response letter within 30 days.

Advisory Committees Drug Review

Ardelyx’s Tenapanor: FDA Panel To Weigh Treatment Effect Size In Context Of Approved Agents

Agency previously declined to approved tenapanor for the control of serum phosphorous levels in chronic kidney disease patients on dialysis, saying the magnitude of treatment effect on a surrogate endpoint in three clinical trials was less than that observed with approved drugs and of unclear significance.

Advisory Committees Drug Review
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