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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

US FDA’s Science Strategies Program Aims To Proactively Tackle Drug Development Hurdles

The goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.

Clinical Trials Research & Development

Moderna’s Pediatric COVID Vaccine Packaging Spurs Confusion Concerns From CDC Panel

Discrete packaging for authorized dose in 6-11 year-olds is not yet available, so vaccination providers have to use product from a vial labeled for ‘booster doses only’ in adults. ACIP members unanimously endorse use of the mRNA vaccine in individuals ages 6-17 years but urge manufacturers to move away from relying on color to differentiate formulations.

Coronavirus COVID-19 Vaccines

Acadia’s Nuplazid Needs Another Study For Alzheimer’s Psychosis, US FDA Panel Says

Advisory committee members cited a litany of shortfalls with efficacy data from two existing studies and say a new Phase III trial is needed in a large, ethnically and racially diverse population of Alzheimer’s disease psychosis patients.

Advisory Committees Drug Review

Acadia’s Nuplazid: US FDA Panel Will Focus On Efficacy For Alzheimer’s Disease Psychosis

Agency questions clinical significance of change in primary efficacy endpoint measured in one study and raises doubts about numerous exploratory analyses for a second study aimed at explaining why Alzheimer’s patient subgroup appeared to derive less benefit than other types of dementia patients.

Advisory Committees Drug Review

Moderna’s Vaccine Gets Panel Nod In Adolescents, Older Children; Committee Already Eyes Booster

US FDA advisory committee members debate how a third dose, or booster, of the COVID vaccine should fit into the mix of an EUA expansion for the 12-17 and 6-11 groups; Moderna expects to have immunogenicity and safety data on booster doses in both of age groups by mid-July.

Advisory Committees Coronavirus COVID-19

Moderna COVID Vaccine’s Myocarditis Risk Has Improved With Time, US FDA Says

‘Robust results’ from recent US surveillance studies show slight decreases in the myocarditis risk differential between the Moderna and Pfizer/BioNTech vaccines, agency says in briefing documents for panel review of Moderna’s pediatric EUA request.

Advisory Committees Coronavirus COVID-19
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