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BioWorld - Wednesday, February 11, 2026
Home » Topics » Regulatory » Policy

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Loss of experience at US FDA raises concerns as impacts felt

April 10, 2025
By Mari Serebrov
“We’ve lost 1,000 person-years of expertise in a few weeks,” former U.S. FDA Commissioner David Kessler said in an April 9 House Oversight and Government Reform hearing as he discussed the impact of the termination of 3,500 FDA employees the previous week, on top of the 1,000 who were let go or offered retirement in February.
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Pill bottle spilling over EU flag

Many US tariffs paused, pharma warned, EU put on notice

April 9, 2025
By Mari Serebrov
The on-again, off-again U.S. tariffs are off again, at least for now, for more than 75 countries that have reached out to the Trump administration to negotiate instead of retaliating. The 90-day pause will provide some breathing room for the med-tech industry. Pharmaceuticals and active pharmaceutical ingredients were among the few products exempted from the reciprocal tariffs, but that exemption for pharmaceuticals was expected to be short-lived. Meanwhile, pharma CEOs warned European Commission President Ursula von der Leyen April 8 that, unless the EU quickly changes its policy, pharmaceutical research, development and manufacturing is increasingly likely to be directed to the U.S.
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U.S. trade illustration

Many med-tech company supply chains protected from tariffs

April 8, 2025
By Annette Boyle
In the wake of the pandemic, many leading med-tech companies took steps to on-shore and near-shore manufacturing, a move that could protect significant numbers of players from the worst of the effects of the tariffs announced by the Trump administration last week.
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Global market charts

Markets lose ground as US Senate meets on Trump tariffs

April 8, 2025
By Mark McCarty
The April 8 Senate hearing on the Trump administration’s tariffs generated some heated debate, although U.S. Trade Representative Jamieson Greer parried some of the criticism by pointing to the yawing trade deficit.
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World trade illustration

Europe’s med-tech companies assessing implications of tariffs

April 8, 2025
By Shani Alexander
Med tech and diagnostic companies in Europe are considering strategies to navigate the U.S. market following President Trump’s introduction of reciprocal tariffs on imports. While some companies are more exposed than others, there’s no doubt that many will feel the pain.
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Globe isolated on white background with focus on Asia and Australia

Asia in firing line of Trump tariffs, but health care escapes largely unscathed

April 8, 2025
By Tamra Sami
Following news of U.S. President Donald Trump’s 10% across-the-board tariffs on Australian exports to the U.S., Australia’s Securities Exchange shed nearly AU$55 billion in losses Thursday morning. Even so, pharmaceuticals have escaped the tariffs for now. In China, Trump’s tariffs are not a big concern for China’s health care because drugs and active pharmaceutical ingredients are exempted from the tariffs. Even if tariffs are imposed in the future, Chinese pharmaceutical companies have already significantly de-risked themselves in recent months by increasing out-licensing models with U.S. partners.
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Syringe on map of Africa

Experts cite deadly consequences of PEPFAR funding disruption

April 8, 2025
By Nuala Moran
The extent of the damage that will be caused if the U.S. overseas aid program, the President’s Emergency Plan for AIDS Relief (PEPFAR), is axed or has its funding cut, is laid out in an expert analysis published in The Lancet April 8, which estimates nearly 500,000 children could die from AIDS-related causes by 2030, while 1 million children will be infected with the virus.
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Collection of vials

Much-needed predictability lacking in US biosimilar market

April 8, 2025
By Mari Serebrov
Ill-considered government policies, pharmacy benefit manager market abuses and an unpredictable future are casting doubt on the long-term sustainability of the U.S. biosimilar market, Craig Burton, the executive director of the Biosimilars Council, told a House Ways & Means subcommittee April 8.
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Judge's gavel with US flag

US court says no to NIH indirect rate cut, another suit filed

April 7, 2025
By Mari Serebrov
The nationwide preliminary injunction keeping the U.S. NIH from slashing its indirect cost rate to a flat 15% has become permanent. In issuing the permanent injunction and final judgment April 4 in three challenges to the rate change, Judge Angel Kelley, of the U.S. District Court for the District of Massachusetts, said the NIH’s Feb. 7 notice that it would begin imposing the 15% rate Feb. 10 to all existing and future grants violated the Administrative Procedure Act, as the action was arbitrary and capricious, was impermissibly retroactive and failed to follow notice-and-comment procedures.
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Red dollar sign under microscope

Trump cuts are 'gutting' research grants, 'destabilizing' science

April 4, 2025
By Nuala Moran
“The nation’s scientific enterprise is being decimated.” That statement in an open letter “to the American people” signed by 1,800 members of the U.S. National Academies, is made concrete in a list of 709 NIH grants – and counting – that have been axed since President Donald Trump was inaugurated on Jan. 20.
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