Eisai Co. Ltd., of Tokyo, and Merck & Co. Inc., of Kenilworth, N.J.
Unresectable hepatocellular carcinoma
Approved in China for use as a single agent in patients who have not received prior systemic therapy
Hutchison China Meditech Ltd., of London
Oral, small-molecule VEGFR1, 2,3 inhibitor
Metastatic colorectal cancer
Approved by China's National Medical Products Administration for use in patients who have failed at least 2 prior systemic antineoplastic therapies, including fluoropyrimidine, oxaliplatin and irinotecan, with or without prior use of anti-VEGF or anti-EGFR therapies
Innovent Biologics Inc., of Suzhou, China
Fully human anti-CD47 monoclonal antibody
China's National Medical Products Administration cleared the IND; firm plans to launch trials in multiple tumor types, including non-Hodgkin's lymphoma and ovarian cancer
Mabspace Biosciences Co. Ltd., of Suzhou, China
Gastric, non-small-cell, colorectal and hepatocellular cancers
Submitted IND application to the National Medical Products Administration of China
Sihuan Pharmaceutical Holdings Group Ltd., of Beijing
Long-acting recombinant insulin analog
National Medical Products Administration of China greenlighted trials
Vertex Pharmaceuticals Inc., of Boston
CFTR corrector/CFTR potentiator
Finalized agreement with Australian government allowing for reimbursement for patients, 6 and older, with CF who have 2 copies of the F508del mutation in the CFTR gene
The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.
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