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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

Ponvory’s Regulatory Timeline At The US FDA And EMA

Janssen’s ponesimod for relapsing multiple sclerosis had a slightly faster review in the US.

Europe Drug Review Profile

Fatigue Benefit With Janssen’s MS Drug Ponvory Not Clinically Relevant – US/EU Regulators

In approving ponesimod for relapsing multiple sclerosis, neither the FDA nor EMA included in labeling data from a novel patient-reported outcomes fatigue instrument; FDA said the PRO was not shown to be capable of measuring within-patient change, while EMA said the difference relative to Sanofi’s Aubagio fell short of the threshold for a clinically meaningful benefit.

Drug Review Profile Drug Review

Beyond Vaccines: CDC's ACIP To Look At Antibodies For Respiratory Syncytial Virus Prevention

New maternal/pediatric work group will consider recommendations for use of RSV vaccines and monoclonal antibodies targeting protection of children <18 years. With several products in the late-stage pipeline, group has begun reviewing RSV epidemiology and discussing cost-effectiveness.

Advisory Committees Cost Effectiveness

US CDC Panel’s Pneumococcal Vaccine Recommendations Leave Confusion In Their Wake

Advisory Committee on Immunization Practices’ October vote on use of Pfizer’s Prevnar 20 and Merck & Co’s Vaxneuvance was more restrictive than intended, inadvertently leaving out guidance for people who were previously vaccinated with Prevnar 13.

Vaccines Advisory Committees

Paxlovid Prescribing Complicated By Dosing Adjustment For Renal Impairment, Drug-Drug Interactions

In the EUA for Pfizer’s COVID-19 oral antiviral treatment, US FDA required a reduced dose for some renally impaired patients that is ‘incongruent with how Paxlovid is packaged,’ meaning that pharmacists have to manually make changes to each blister pack. Prescribers will have to navigate an extensive list of contraindicated medicines due to CYP3A effects.

Drug Review Coronavirus COVID-19

Merck/Ridgeback’s COVID-19 Drug Molnupiravir Met EUA Bar, But More Data Needed For Full Approval – US FDA

Reviewers believed it was worth making the oral antiviral available for second-line use under the relatively low bar for emergency authorization despite the drug’s significant potential risks, ‘modest benefit’ and ‘unexplained difference’ in efficacy results from the interim and full analysis populations in the pivotal trial.

Drug Review Coronavirus COVID-19
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