Company |
Product |
Description |
Indication |
Status |
Date |
Aivita Biomedical Inc., of Irvine, Calif. |
Root of cancer |
Autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells |
Solid tumors |
Completed manufacturing quality consultation and clinical safety consultation with Japan's PMDA; will move forward to the final round of discussions focused on the clinical protocol |
10/15/18 |
Innovent Biologics Inc., of Suzhou, China |
IBI-308 (sintilimab) and IBI-305 (bevacizumab biosimilar) |
Anti-PD-1 monoclonal antibody and anti-VEGF antibody |
Non-small-cell lung cancer and hepatocellular carcinoma |
China's National Medical Products Administration approved the IND for clinical development of the combination |
10/15/18 |
JHL Biotech Inc., of Hsinchu, Taiwan |
JHL-1149 |
Bevacizumab biosimilar |
Several forms of cancer |
China's National Medical Products Administration approved the phase I and phase III clinical trial applications for the biosimilar in several forms of cancer, including advanced non-squamous non-small-cell lung cancer, metastatic colorectal cancer, metastatic kidney cancer, advanced cervical cancer and recurrent ovarian cancer |
10/15/18 |
Peptilogics Inc., of Pittsburgh |
PLG-0206 |
Antimicrobial |
Prosthetic joint infection and multidrug-resistant bacterial infections |
Cleared by Australia's TGA to begin phase I testing |
10/15/18 |
Teva Pharmaceutical Industries Ltd., of Jerusalem, and Celltrion Inc., of Incheon, South Korea |
CT-P10 |
Biosimilar to rituximab |
Non-Hodgkin lymphoma |
FDA's Oncology Drugs Advisory Committee voted 16-0 to recommend approval of the biosimilar for 3 proposed indications: relapsed or refractory low-grade or follicular CD20-positive B-cell non-Hodgkin lymphoma; previously untreated follicular CD20-positive B-cell NHL in combination with first-line chemotherapy and for patients achieving complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone chemotherapy |
10/10/18 |
Yisheng Biopharma Co. Ltd., of Beijing |
Pika rabies vaccine |
Vaccine using Toll-like receptor-3 immuno-modulating technology |
Rabies |
China regulators provided clearance to proceed with a clinical trial |
10/9/18 |
Notes The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found. For more information about individual companies and/or products, see Cortellis. |