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Drugmakers must disclose U.S. production plans to qualify for tariff exemptions

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Recent reporting says the Trump administration imposed 100% tariffs on patented pharmaceuticals and certain pharmaceutical ingredients imported from most countries. Drugmakers can avoid or reduce the tariffs if they enter approved agreements with the Department of Health and Human Services tied to most-favored-nation pricing and onshoring production. Companies that submit official plans to build U.S. manufacturing facilities may receive a reduced 20% tariff rate during construction, with the rate set to rise later if no full relocation occurs. The White House said the policy is intended to protect national security, reduce reliance on imported medicines, and encourage domestic drug manufacturing. Generic drugs and biosimilars were not targeted by the action at this time. The proclamation applies Section 232 authority, which allows tariffs or import restrictions for national security reasons. Sources:

Aardvark to unblind Phase 3 ARD-101 data early after FDA clinical hold

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Biogen advances anti-tau Alzheimer’s drug diranersen despite mixed Phase 2 results

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Mochida Pharmaceutical: Notice Concerning Changes in Directors

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Tempus Expands Strategic Collaboration with Bristol Myers Squibb to Use AI and Real‑World Data to Improve Clinical Trial Success

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Datar Cancer Genetics Announces US FDA Clearance for CellDx-Tissue

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Bora snaps up MacroGenics' manufacturing, CDMO operations for up to $127.5M

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BeOne's Beqalzi wins FDA accelerated approval as first BCL-2 inhibitor for mantle cell lymphoma

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Create Medicines raises $122M to advance in vivo CAR-T programs

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Biogen advances Alzheimer’s tau program despite midphase miss

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Valneva to cut up to 15% of jobs as reduced travel hits vaccine demand

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Recent developments in transforming oversight and risk management in pharma R&D

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28bio Launches CNS-3D Myelinated Organoids to Predict Therapeutic Efficacy

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