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BioWorld - Wednesday, February 4, 2026
Home » Topics » Regulatory » Policy

Policy
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Pills and percentage sign

Industry looking to adapt under shadow of US Rx tariffs

Aug. 1, 2025
By Mari Serebrov
No Comments
While U.S. President Donald Trump’s country-by-country reciprocal and newly negotiated tariffs go into effect today, a separate, global biopharma sector tariff of, possibly, 200% continues to loom over the sector. For many stakeholders, a biopharma sector tariff of even 25%, as first proposed by Trump, would be a disaster in the making, especially when combined with the pressures of Medicare price negotiations and the president’s escalation of most-favored-nation pricing.
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U.S. Capitol building, Washington D.C.

NIH to receive a $400M boost under Senate spending bill

July 31, 2025
By Mark McCarty
The Senate Appropriations Committee met July 31 to markup legislation that would fund the Department of Health and Human Services – including an additional $400 million for the National Institutes of Health. The increase in NIH funding repudiates the Trump administration’s efforts to drastically cut those appropriations, which is an outcome marking a clear win for companies in the life sciences.
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Adopt MFN pricing or else, drug companies told

July 31, 2025
By Mari Serebrov
No Comments
President Donald Trump sent letters July 31 to the CEOs of 17 major drug manufacturers doing business in the U.S., giving them 60 days to comply with his May 12 executive order (EO) on most-favored-nation (MFN) pricing. The EO appealed to drug companies to undertake MFN pricing voluntarily to end the freeloading in which other developed countries pay, on average, three times less than Americans are charged for the same medicines.
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Exterior of NIH Vaccine Research Center

Republican senators flag NIH funding delays

July 28, 2025
By Mari Serebrov
No Comments
While U.S. government cost-cutting seems to be the Trump administration’s priority that consumes all others, some Republican senators are pushing back – at least when it comes to the NIH. Fourteen senators wrote to Russell Vought, head of the White House Office of Management and Budget, to voice their concerns about the administration’s slow disbursement rate of the NIH’s fiscal 2025 funds.
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U.S. flag and White House podium

Trump administration’s AI action draws props from med tech

July 24, 2025
By Mark McCarty
The Trump administration released an action plan for AI, which includes an exports program for full-stack AI in areas such as health care. The announcement drew the support of the Advanced Medical Technology Association, which described the initiative as an accelerant for the use of AI in health care and a boon to patient outcomes.
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US flag, Department of Health and Human Services flags

US organ donation system in crisis as Congress, HHS weigh in

July 22, 2025
By Mark McCarty
The U.S. organ donation system is once again under pressure from both the executive and legislative branches thanks to media reports detailing an instance in which a surgeon refused to harvest organs from a potential donor who had not expired.
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Blue injector pens

Biocon wins first FDA interchangeable label of Novolog biosimilar

July 22, 2025
By Marian (YoonJee) Chu
No Comments
The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a rapid-acting diabetes medication.
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Blue injector pens

Biocon wins first FDA interchangeable label of Novolog biosimilar

July 18, 2025
By Marian (YoonJee) Chu
No Comments
The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a rapid-acting diabetes medication.
Read More
Prescription drug bottles and pills

Rx tariffs a few weeks away?

July 16, 2025
By Mari Serebrov
No Comments
“Pharmaceuticals will be tariffed, probably at the end of the month,” U.S. President Donald Trump said, as he provided a few more details about his proposed global biopharma sector tariff. “We’re going to start off with a low tariff and give the pharmaceutical companies a year or so to build. And then we’re going to make it a very high tariff.”
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Cyber security padlock

Preemption of state privacy law on tap in cybersecurity hearing

July 14, 2025
By Mark McCarty
The continuing proliferation of U.S. state privacy law drew the attention of developers of med-tech wearables for some time, but a recent Senate hearing delivered the news to Congress that a failure to preempt it will slow digital health innovation to a crawl.
Read More
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