Month: February 2018


FDA to Refuse Celgene for Filling Ozanimod’s NDA for the

 Shots:      •  The rejection of Ozanimod was based on unmet preclinical and clinical trials results, in patients with relapsing multiple sclerosis    •  Additionally, Celgene plans to resubmit NDA, with onset of Type A meeting with FDA regarding development of the product    •  Ozanimod is an oral sphingosine 1-phosphate 1 (S1PR1) and […]Read More

Biosimilars Regulatory

Celltrion’s Herzuma (Trastuzumab Biosimilar, CT-P6) Receives EMA Approval for Breast

Shots: The approval is based on positive opinion by CHMP (EMA) assessing Herzuma and reference trastuzumab in patients with HER2 overexpression/gene amplification tumors in breast cancer, metastatic breast cancer and metastatic gastric cancer The study resulted in a non-inferiority data demonstrating efficacy, safety, immunogenicity, PD and PK in patients Herzuma (trastuzumab biosimilar, CT-P6) is a […]Read More


Janssen’s Erleada (apalutamide) Receives FDA Approval for Non-Metastatic Castration-Resistant Prostate

Shots: The approval is based on P-III SPARTAN study results assessing Erleada (240 mg,qd) vs PBO in 1,207 patients with NM-CRPC in ratio (2:1) in patients with (NM-CRPC) P-III SPARTAN study results: 72% reduction in risk of distant metastasis or death; mPFS (40.51 mos. vs 16.20 mos.); 24% required number of events Erleada (apalutamide) is […]Read More


Celgene to Acquire Juno for its Cellular Immunotherapy & Hematology

Shots: Celgene acquires Juno, in all stock transaction with its JCAR017& JCARH125 clinical products. Juno to receive $87/share in cash, making total deal value as $9B The focus of the agreement is to develop drugs in fields of oncology and hematology with Juno’s cellular immunotherapy platform and research capabilities JCAR017 (lisocabtagene maraleucel; liso-cel) is a […]Read More