Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
REGULATORY
PMDA Urges Quality-Driven Biosimilar Development as CES Waivers Take Hold
Japan’s drug regulator is urging biosimilar developers to move away from comparative efficacy studies (CES) as a default and adopt a quality-driven approach to determining what studies are actually needed. Rather than conducting CES “by default,” companies should identify what…
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