China
New Phase 3 data show that Summit Therapeutics and Akeso’s PD-1/VEGF therapy improved overall survival in patients with a type of lung cancer as compared to Merck’s Keytruda but the results will need to be replicated in non-Chinese patients.
Inspection access is not “an administrative footnote,” leaders of key FDA divisions wrote in an editorial on Wednesday vowing to expand oversight of foreign clinical trial sites.
The U.S. is scrambling to compete with a strategically positioned China on the biotech stage as the Asian country surpasses America in biomedical research and clinical trials. So far, China is winning.
Through its DualityBio deal, Roche’s Genentech hopes to create antibody-drug conjugates with payloads that can circumvent growing cancer drug resistance.
Three fatalities occurring recently in Chinese clinical trials have spurred two members of U.S. Congress to urge the FDA to enact new policies designed to protect American patients.
Massachusetts-based biotech accelerator LabCentral signed an agreement with Hong Kong Science and Technology Parks Corporation in June to connect founders with the U.S. ecosystem—and fuel more innovation.
Ivonescimab notched its third approval in China last week, but the label update has tempered expectations for the Summit Therapeutics/Akeso drug, showing that progression-free survival declines over time.
News of the joint venture comes months after AstraZeneca vowed to spend $15 billion in China by the end of the decade.
Pathos AI could pay more than $2 billion to a Jiangsu Alphamab Biopharmaceuticals subsidiary for a late-stage bispecific antibody-drug conjugate for breast cancer, while the financial details of the AstraZeneca agreement were not disclosed.
When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.
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