Bio News

The Ministry of Food and Drug Safety issued an advance notice on Aug. 25 of proposed revisions to regulations governing the approval and notification of herbal (crude drug) medicine products. For over-the-counter drugs, the revisions specify the dosage forms eligible for approval without equivalence data when differences in dosage form are minor. The MFDS plans to accept comments through Sept. 15 and revise its approval and review criteria.

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?