OncoZenge AB (publ) ("OncoZenge" or "the Company") today announces the appointment of Linda Nord as Head of Regulatory Affairs. Linda joins OncoZenge at a pivotal moment with impending Phase III trial initiation and focus turning to preparations for Market Authorization Application (MAA), following the Company’s successful clinical trial application.
The Company has successfully received European regulatory approval to initiate its pivotal Phase III trial ‘BEAM-Pain’. With impending patient recruitment the Company sets its focus on the preparations needed for a successful Market Authorization Application (MAA), in collaboration with its European commercial partner Molteni Farmaceutici.
The Company today announces the appointment of Linda Nord as Head of Regulatory Affairs. Linda succeeds Christina Junvik who has successfully led OncoZenge through CTA approval in Europe.
“I would like to extend my deep gratitude to Christina for her diligence and extraordinary efforts in leading OncoZenge through the development of a robust clinical trial application for BupiZenge™, and the ensuing process with the authorities towards the recent decision to approve patient recruitment for our Phase III trial, BEAM-Pain. Our focus now turns to trial execution, and in parallel efforts to prepare for market approval. As part of that process we will also continue our engagement with the Paediatric Committee (PDCO) to advance the pediatric development strategy. We look forward to welcome Linda to the team to lead our regulatory efforts to ready the company for MAA, and to support global licensees with their local registrations” - Stian Kildal, CEO of OncoZenge.
Linda Nord holds a PhD in Neuroscience and Cell Biology from the Karolinska Institute. She is a principal consultant within Regulatory Affairs with more than 15 years of experience in the life science industry, including roles at AstraZeneca and Sobi, with a strong focus on guiding global drug development programs. She has served as regulatory lead for multiple branded product approvals, driving strategy and execution across FDA, EMA, and key international markets including Asia Pacific and Latin America. Her expertise spans both small molecules and biologics, with deep strength in CMC regulatory management.