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BioWorld - Sunday, April 5, 2026
Home » Topics » Regulatory » Policy

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Illustration of TAVR device

CMS disinclined to reassign TAVR procedures to higher-paying DRG​

April 14, 2025
By Mark McCarty
The U.S. Medicare draft inpatient rule for fiscal 2026 discusses a number of coding proposals, although the agency seems disinclined to go along with a proposal to increase payment rates for TAVR devices by switching the procedures to a different diagnostic-related group.
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New UK law aims for ‘faster, fairer and more inclusive’ clinical trials

April 14, 2025
By Nuala Moran
As new clinical trials regulations were signed into law in the U.K., an analysis of 4,616 submissions to conduct studies has highlighted what is required for the updated law to translate into a more efficient, streamlined and adaptable regulatory framework.
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Data privacy illustration

States active on privacy as Congress convenes work group

April 11, 2025
By Mark McCarty
The thicket of state-based privacy regulation in the U.S. grows thicker by the day, but Congress seems poised to step in with a bipartisan group that may propose legislation that preempts privacy law.
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Novartis radioligand manufacturing

Novartis boosting US manufacturing with $23B investment

April 11, 2025
By Nuala Moran
Two days after pharma companies sounded an alarm that their investments were headed out of Europe, Novartis AG has announced plans to increase investment in the U.S. by $23 billion, bringing the total it invests over the next five years to nearly $50 billion.
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US flag, stock market chart, White House

Dems petition White House to ensure drug supply chains stay intact

April 10, 2025
By Mark McCarty
The Trump administration applied a 90-day hold on nation-specific tariffs, but a group of 26 House Democrats urged the administration to think carefully before acting on a threat to impose tariffs on pharmaceuticals.
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FDA icons

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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