Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
PT Etana Biotechnologies Indonesia secured a series B financing of undisclosed value, led by Chinese investors that include Jack Ma’s Yunfeng Capital and Highlight Capital. The funds will be used to strengthen the company's pipeline and to expand its local manufacturing capacity.
Worg Pharmaceuticals Co. Ltd. raised nearly ¥400 million (US$55.6 million) in its series B financing. Founded in 2018, the company is developing immunotherapies to treat allergic and autoimmune diseases and other indications based on its two technology platforms, Pcfit and Apitope.
South Korea's LG Chem Ltd., seeking new growth opportunities in the life sciences and a concrete footprint in the U.S., has proposed an all-cash acquisition of Aveo Pharmaceuticals Inc., with a deal value of $519.2 million.
South Korea’s drug regulator should consider revising orphan drug definitions or allow more new innovative drugs to be excluded from pharmacoeconomic assessments, which are required for new drugs to be reimbursed under Korea’s single-payer system, the European Chamber of Commerce in Korea said.
A new analysis of Actinogen Medical Ltd.’s phase II Xanadu trial showed that in biomarker-positive patients with mild Alzheimer’s disease there was a clear clinical effect with lead compound Xanamem not seen in the earlier trial.
CSPC NBP Pharmaceuticals Co. Ltd. entered an agreement that will grant it exclusive rights to Harbour Biomed Co. Ltd.’s anti-FcRn antibody, batoclimab (HBM-9161), in greater China, including Hong Kong, Macau and Taiwan.
Cerecin Inc. has successfully closed the first tranche of a series IIB financing with investors from South Korea, with SK Securities Co. Ltd. and KNT Investment LLC leading the round.
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.
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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