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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.

Latest From Sue Sutter

Cancer Trials Should Focus On Collecting Data ‘Strictly Necessary’ For Assessing Efficacy

In journal article, leaders from academia, industry, NCI and FDA propose building upon pandemic-necessitated flexibilities in clinical research, including making it easier for trial participants to access investigational drugs in their own communities and reduced reporting of uninformative adverse events.

Clinical Trials Coronavirus COVID-19

Aduhelm's Journey To Accelerated Approval: Finding Buried Treasure In Uncharted Waters

The Alzheimer’s drug’s regulatory voyage to accelerated approval was circuitous – a destination briefly visited but one that reappeared on the horizon only as time ticked down on the application’s user fee goal date.

Approvals Review Pathway

FibroGen’s Roxadustat Rejected By US FDA Panel Due To Safety Concerns, Untested Dosing Strategy

But advisory committee members see a potential opportunity for the oral anemia drug in small percentage of dialysis-dependent patients not responsive to erythropoiesis-stimulating agents; FibroGen’s revised dosing algorithm, aimed at slowing hemoglobin rate of increase and reducing risk of thrombosis, needs to be clinically tested before marketing approval, panelists said.

Advisory Committees Drug Review

FibroGen’s Roxadustat Faces US FDA Scrutiny On ‘Prominent’ Safety Signals Relative To Erythropoietin

Risks of serious thrombotic events, seizures and infection make the benefits of the first-in-class oral drug for treating anemia related to chronic kidney disease ‘difficult to calculate’ despite demonstrated improvements in hemoglobin, FDA says in advisory committee briefing document.

Advisory Committees Drug Review

3,189 Days: Aduhelm Phase IV Timeline Is Long Among Alzheimer’s Drugs And Other Accelerated Approvals

Pink Sheet and Trialtrove analyses show time given Biogen to complete confirmatory trial exceeds duration of most other late-stage trials of anti-amyloid compounds and is almost double the average time allocated for follow-up studies of novel accelerated approvals since 2016; runway could reflect expectations for a longer follow-up period or potential enrollment challenges.

Clinical Trials Review Pathway

Pediatric Cancer: US FDA May Invite European Regulators To Observe ‘Type F’ Meetings With Sponsors

Early advice meetings allow sponsors to hear the FDA’s current thinking about relevance of a specific molecular target and expectations for early assessment of an adult cancer drug in children unless a waiver or deferral is justified; agency has waived subsequent pediatric studies for some same-in-class products, including PD-1/L1 inhibitors.

ImmunoOncology Pediatrics
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