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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 CDC Panel Supports Moderna, Janssen COVID Vaccine Boosters But Strips Out Preference Language For Homologous Dosing

ACIP pushes back on proposed policy recommendation that the same product used for the primary regimen should be used for the booster, saying risk/benefit and other considerations necessitate more flexibility afforded by 'mix and match' approach.

Coronavirus COVID-19 Vaccines

Moderna, Janssen And ‘Mix & Match’ Boosters Create A ‘Not Simple’ Array Of Dosing Options

After US FDA authorization for additional COVID vaccine shots, the focus now shifts to CDC’s advisory committee, which may be concerned about variations in eligible populations, timing and dosing when it comes to giving a booster different from the primary vaccination series.

Coronavirus COVID-19 Vaccines

Makena Withdrawal Hearing: US FDA Drugs Center, Covis Tussle Over Panel Composition

Practicing obstetricians who are maternal fetal-medicine specialists should make up a ‘significant proportion’ of the advisory committee at the forthcoming hearing, Covis says; CDER calls for a more ‘balanced’ panel that includes expertise in biostatistics, neonatology and epidemiology.

Review Pathway Post Market Regulation & Studies

Moderna's COVID-19 Vaccine Booster US FDA Panel Nod Driven By Pragmatism

Despite lack of enthusiasm with immunobridging study data, the panel endorsed emergency use in certain at-risk populations, in part because it would be hard to turn down the Moderna booster when an identical EUA had been issued for Pfizer/BioNTech's mRNA vaccine.

Coronavirus COVID-19 Vaccines

Moderna COVID-19 Vaccine: Booster Study Hits Only One Of Two Immunogenicity Endpoints

Immune responses to a single booster dose of mRNA-1273 would be considered successfully bridged to the two-dose primary series if each of two immunobridging criteria were met, but the mRNA vaccine missed the prespecified success criteria for seroresponse rate, the FDA said.

Advisory Committees Coronavirus COVID-19

Takeda’s Maribavir Post-Transplant CMV Indication Should Not Be Limited By Resistance, US Panel Says

Advisory committee unanimously endorses novel antiviral for treatment of post-transplant patients with refractory/resistant cytomegalovirus infection, and in the process rejects US FDA’s proposal to distinguish target population based upon genetic resistance.

Advisory Committees Drug Review
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