Shots: Novartis acquires AveXis, in all stock transaction with its AVXS-101 candidate for replacing the defective SMN1 gene. AveXis to receive $218/share making total deal value $8.7B The focus of […]readmore
Shots: The approval is based on CHMP (EMA) recommendation, reviewed by EU for diabetic patients In 2009, Mylan and Biocon globally collaborated to jointly develop multiple generic biologic compounds Semglee […]readmore
Biosimilars
Regulatory
Amgen and Allergan’s ABP 980 (biosimilar, Herceptin) Receives CHMP Recommendation
Shots: The CHMP recommendation is based on P-III study results assessing ABP 980 in adult female patients with HER2-positive early breast cancer The P-III study resulted in analytical, PK, pharmacology, […]readmore
Regulatory
Uncategorized
Rigel Pharmaceuticals’ Tavalisse (fostamatinib disodium hexahydrate) Receives FDA Approval for
Shots: The approval is based on three FIT studies results assessing Tavalisse (100/150mg, bid) vs Placebo in 150 patients with chronic ITP in ratio 2:1 The FIT studies result: FIT-1 […]readmore
Regulatory
TaiMed Biologics’ Trogarzo (ibalizumab-uiyk) Receives Approval for Multidrug Resistant (MDR)-HIV
Shots: The approval is based on clinical study results assessing Trogarzo (ibalizumab, IV) in 40 patients with MDR-HIV The study resulted in depletion of HIV-RNA level in blood in 43% […]readmore
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 […]readmore
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 […]readmore
Regulatory
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 […]readmore
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 […]readmore
Shots: Sanofi acquires Bioverativ, in all stock transaction with its Eloctate & Alprolix products. Bioverativ to receive $105/share in cash for a premium of 64 % with total deal value […]readmore