Thursday 16 October, 2025
INTRODUCTION COSENTYX® (secukinumab) was originally approved in Spondyloarthritis (SpA) with two subcutaneous (SC) regimens, with maintenance doses of 150 and…
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Straight-to-Phase 3: MIDD accelerates depemokimab clinical development in Type 2 inflammatory conditions
Thursday 16 October, 2025
Objectives: We describe the accelerated development of depemokimab, the first ultra-long-acting anti-IL-5 biologic for Type 2 inflammatory conditions, by transitioning…
Read moreCredibility assessment of model informed drug development approaches in paediatric and rare diseases: a review of EMA submissions and assessment reports from 2014 to 2024
Thursday 16 October, 2025
“The currently used model for regulating drug development was established more than 40-years ago, and is compartmentalized based on the…
Read moreImplementation of an MIDD strategy for ruxolitinib dosing in pediatric GvHD populations, and varying opinions of regulators
Thursday 16 October, 2025
Introduction: Ruxolitinib is approved globally for the treatment of myelofibrosis (MF) and Polycythemia Vera (PV) in adults, and acute/chronic Graft…
Read moreModel based extrapolation of efficacy to support Baloxavir Marboxil for uncomplicated influenza in children aged <1 year
Thursday 16 October, 2025
Objectives Baloxavir marboxil (Bxm) is an antiviral prodrug that is converted by hydrolysis to the active form baloxavir acid, a…
Read moreModel-informed drug development provide pivotal evidence for approval of semaglutide 1.7 mg in adolescents living with obesity
Thursday 16 October, 2025
Introduction Once-weekly semaglutide subcutaneous 2.4 mg, a glucagon-like peptide-1 receptor agonist, was approved in 2021 to treat adults with an…
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