Inspectors from the U.S. Public Company Accounting Oversight Board (PCAOB) have reportedly arrived in Hong Kong to inspect audit records for the Chinese companies listed by the U.S. SEC as being noncompliant with U.S. accounting standards.
Japan’s Ministry of Health, Labor and Welfare approved Daiichi Sankyo Co. Ltd.’s Ezharmia (valemetostat tosilate), the first dual inhibitor of histone methyltransferases EZH1 and EZH2 for the treatment of patients with relapsed or refractory adult T-cell leukemia and lymphoma. It’s Daiichi Sankyo’s fifth new oncology medicine approved in Japan in the past three years.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: AB Science, Adamis, Ascletis, Effector, Omeros.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Anbogen, Astrazeneca, Atea, ATMA Journey Centers, Belite, Biontech, Cstone, Gilead Sciences, H. Lundbeck, I-Mab, Innocare, Novavax, Otsuka, Pfizer, Revive, Takeda, Transcenta, Vaxxinity.
Basilea Pharmaceutica Ltd., having advanced a first-in-class cancer drug through preclinical studies, is selling some rights and sublicensing others for the dual-kinase inhibitor to Sillajen Inc.
An antibody that protects babies against respiratory syncytial virus (RSV) from Astrazeneca Ltd. and Sanofi SA was among a string of recommendations from the EMA’s Committee for Medicinal Products for Human Use, paving the way for approval within the next few months and a potential launch in 2023.
The University of Texas MD Anderson Cancer Center and Radiopharm Theranostics Ltd. have launched Radiopharm Ventures LLC, a joint venture (JV) that will develop radiopharmaceutical therapies for cancer. Radiopharm Theranostics owns 51% of shares in the new entity, while MD Anderson owns 49%.
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