Nature Cell Co. Ltd. won U.S. FDA breakthrough therapy designation of its autologous adipose-derived mesenchymal stem cell therapy, Jointstem, March 20, becoming the first Korean company to earn the label in the field of cell therapy.
In a move that echoes tariff threats from U.S. President Donald Trump, the Pharmaceutical Research and Manufacturers of America (PhRMA) lobby is taking aim at most of the world for unfair trade practices in its special 2025 Special 301 Report to the U.S. Trade Representative.
In a deal that could reach nearly $2 billion, Jiangsu Hengrui Pharmaceuticals Co. Ltd. has licensed a small molecule for treating cardiovascular disease to Merck & Co. Inc., dropping the China-based company into a space with lots of competitors in varying stages of development.
The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents.
Dengue virus (DENV) is a member of the flavivirus family causing dengue fever, a mosquito-borne disease that can be life-threatening. Despite DENV’s widespread presence in over 80 countries and the significant health burden posed by the infection, there is still a critical need for therapeutics and vaccines, with current treatment options only providing supportive care.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Alvotech, Eisai, Glenmark, Henlius, Hutchmed, Telix.
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