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VIEWPOINTS_Olivier Harari_2023
VIEWPOINTS

Olivier Harari, VP, Early Clinical Development at Regeneron Shares his Views on Pozelimab’s BLA Acceptance for the US FDA Priority Review

Shots: Olivier highlighted the P-II/III data based on which Regeneron’s BLA for Pozelimab was accepted by the US FDA under priority review to treat adults and children with CHAPLE disease CHAPLE disease is driven by an overactivation of the complement system due to CD55 deficiency. Pozelimab blocks the activity of complement factor C5 and prevents…
July 17, 2023

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VIEWPOINTS_Dr. Mourad Farouk Rezk_2023
VIEWPOINTS

Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on BLA Acceptance for BIIB800

Shots: Dr. Mourad spoke about the acceptance of aBLA for BIIB800, a Tocilizumab biosimilar candidate for several autoimmune diseases, including rheumatoid arthritis He briefed about the study design and results from the P-III trial which supported the BLA filing This interview focuses on Biogen's notable progress in addressing challenging immunologic conditions, offering potential solutions to…
July 10, 2023

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VIEWPOINTS_Gina Fusaro_2023
VIEWPOINTS

Gina Fusaro, VP, Development Program Lead at BMS Shares her Views on the Acceptance of sBLA by the US FDA and the EMA Validation on MAA for Opdivo

Shots: Gina gave her views on the acceptance of the sBLA by the US FDA and the validation of the Type II Variation Marketing Authorization Application by the EMA for Opdivo as monotherapy for the treatment of patients with completely resected stage IIB or IIC melanoma She also spoke on the epidemiology of melanoma and…
May 16, 2023

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