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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

Cyramza First-Line Lung Cancer Bid Raises Clinical Practice Questions

Lilly is positioning the ramucirumab/erlotinib combination as a first-line alternative for EGFR-positive non-small cell lung cancer that preserves AstraZeneca’s Tagrisso for second-line use; advisory committee members vote 6-5 for expanded indication but express skepticism about adoption.

Advisory Committees Drug Review

US FDA Divided On Expanded Access Requests For Off-Label Use Of Approved Drugs

Agency’s clinical experts favor granting access under regulations intended for investigational drugs but ‘lawyers want consistency under the law,’ FDA’s Woodcock says; use of the expanded access pathway for approved agents is generally unnecessary but may provide sponsors with some regulatory cover, external experts say.

FDA Reimbursement

Rare Disease Gene Therapy Guidance Gives More Flexibility On Placebo-Controlled Trials

US FDA declined stakeholder requests to remove recommendation for placebo controls from a final guidance but added qualifying language on their use ‘when feasible.’ While the agency excised language on biomarker validation from the final guidance, it reaffirmed the need for early establishment of critical quality attributes and critical process parameters.

Gene Therapy Rare Diseases

Lilly’s Cyramza Wins Slim Nod, But Steba’s Tookad Falls Hard At US FDA Panel

Oncologic Drugs Advisory Committee votes 6-5 that ramucirumab’s benefit/risk profile is favorable in first-line lung cancer, but 13-2 that pivotal trial data do not support approval of Steba’s vascular-targeted, photodynamic therapy for low-risk prostate cancer.

Advisory Committees Drug Review

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
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