Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: ARS, Hutchmed, Innovent, Inovio, Praxis, Tiziana.
A federal judge in Maine has put the brakes on a pilot program that would have enabled biopharma companies to offer rebates instead of up-front discounts as part of the 340B program beginning Jan. 1, 2026.
When glucagon-like peptide-1 (GLP-1) receptor agonists entered the market for obesity and overweight indications in recent years, the uptake and enthusiasm drove investor excitement for companies advancing any of the new mechanisms in the space.
Asia, led by China, is no longer just following global pharma trends. It is helping to shape them, and for investors, innovators and policymakers, the question is no longer whether to engage with Asia, but how to engage wisely in this new, more complex world.
Hutchmed (China) Ltd. has moved closer to establishing China’s first domestically developed FGFR-targeted therapy for intrahepatic cholangiocarcinoma, after the National Medical Products Administration (NMPA) accepted its NDA for fanregratinib (HMPL-453) and granted the drug priority review.
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