Once considered almost inevitable, the passage of BIOSECURE – the US legislation aiming at limiting the involvement of Chinese contract development and manufacturing firms in the biotech industry – now seems in a bit of doubt.
Can BIOSECURE Maintain Its Virality In The TikTok Era?
With the sheen of inevitability now scuffed off the BIOSECURE Act, diplomatic efforts to reduce US dependence on Chinese APIs are increasing in prominence. And the power of the legislation itself could be determined by litigation about a video app.
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A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.
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While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
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The main 2025 policy priorities for China's government as outlined in an annual report will include the strengthening of commercial insurance for innovative drugs and opening up cell and gene therapy and the hospital sector to foreign investment.
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US pharma leadership is painting its mission, particularly its goal to end Medicare price controls, as patriotic and essential to America’s global dominance over China, a move that seems designed to align with President Trump’s priorities.
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Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.
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Given the Trump Administration’s intense focus on cutting costs and increasing efficiency, industry and the FDA should focus on what is and is not working in PDUFA VII when negotiating the next agreement, lobbyists said at the BIO CEO and Investor Conference.
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Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.