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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

Expanded Lung Cancer Claim For Lilly’s Cyramza Faces US FDA Scrutiny

Oncologic Drugs Advisory Committee will consider whether a statistically significant benefit on progression-free survival, but no survival advantage, is enough to secure a first-line lung cancer indication for ramucirumab.

Advisory Committees Drug Review

Steba’s Tookad: US FDA Panel To Weigh Novel Endpoints, Missing Data And Toxicities

Sponsor seeks accelerated approval for low-risk, early-stage prostate cancer based on a trial that met its coprimary endpoints, but agency says interpretation of those results is complicated by novelty of the outcomes, data quality issues and increase in genitourinary adverse events.

Advisory Committees Drug Review

Priority Review Voucher Programs Poised For US Legislative Attention In 2020

Unless reauthorized by Congress, the rare pediatric disease program will begin to expire in September; renewal could bring bigger changes across the three PRV programs, including an FDA-requested clarification of biologic products eligible for vouchers and reforms suggested by sponsors and other stakeholders in a recent GAO report.


Review Pathway Legislation

US Researchers Working Toward Universal Coronavirus Vaccine

The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.

Vaccines Manufacturing

‘Abuse-Deterrent’ Opioids May Be Headed For A Terminology Change

US FDA will survey health care providers’ current understanding of analgesic abuse-deterrent formulations and conduct an experimental study exploring the effectiveness of different terminology and descriptions for such products; agency has heard complaints from its own AdComms about terminology around abuse deterrence.

Advisory Committees Drug Safety

Novartis ‘Urgently’ Working To Improve Zolgensma Access Program

Criticism of Novartis/Avexis’s controversial lottery style managed access program for Zolgensma has come largely from Europe, while other countries in Latin America and Asia have been far more receptive.

Europe Gene Therapy
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