Bio News
Celltrion has applied to the Ministry of Food and Drug Safety to amend the global Phase 3 clinical trial plan for CT-P44, a biosimilar of Darzalex, a treatment for multiple myeloma. Under its regulatory strategy, the amendment adjusts the number of trial participants to 394 and will compare the drug’s efficacy and safety with those of the reference product. Celltrion plans to demonstrate biosimilarity through a 2-year clinical trial.
BIOBOOK TEAM
biobookmedia@biobook.co.krAspen Neuroscience and Bambusa Plan U.S. IPOs; Developers of Parkinson’s and Bispecific Antibody Therapies
St. Jude Identifies Cell Marker for High-Risk Neuroblastoma
University of Texas at Austin Develops Flexible Electrode for Recording Brain Waves for a Month Without Shaving Hair
Revolution Medicines Shares Fall 6.3% on Concerns About RASONK’s KRAS Subgroup
GSK Adopts Chai Discovery AI Model After Wet-Lab Validation
Teva Wins FDA Approval for Long-Acting Olanzapine Beltruzza for Schizophrenia
Peptone nears end of two-year Lilly technology evaluation…follow-on deal could be pivotal
HLB Pharmaceutical Completes 60.8 Billion Won Rights Offering, Bets on New Hyangnam Plant as Management Participation Grows
Song Young-sook sells 86 billion won stake; buyer is daughter’s one-person company — Is a second round of Hanmi control battle looming?
