Official action indicated for Biocon arm’s unit in Malaysia after USFDA inspection

Official action indicated for Biocon arm’s unit in Malaysia after USFDA inspection

Representational image only. | Photo Credit: The Hindu Biocon Limited on October 18 said the U.S. health regulator has classified as ‘official action indicated’ for the manufacturing facility of group firm Biocon Sdn Bhd at Johor, Malaysia following an inspection. The OAI (Official Action Indicated) status may cause delay and/or withholding of pending product approvals … Read more

Biocon Biologics says clinical study for drug Itolizumab initiated in India after approval from DCGI

1 598

Biocon’s partner US-based Equillium Inc has expanded its ‘EQUALISE’ study in Systemic Lupus Erythematosus (SLE) and Lupus Nephritis for Itolizumab to clinical centers in India, Biocon Ltd said in a regulatory filing. Biocon Biologics, an arm of biotechnology major Biocon, on Thursday said the clinical study for its biologic drug Itolizumab for the possible indication … Read more