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BioWorld - Tuesday, April 14, 2026
Home » Topics » Regulatory » Policy

Policy
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US flag, stock market chart, White House

100 days of uncertainty

April 28, 2025
The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the uncertainty, BioWorld continues to cover the administration’s latest policy decisions and actions affecting the life sciences sector, as well as their impacts across the globe. It’s all right here at Trump administration impacts.
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Financial charts, test tubes, capsules, syringe

Med tech majors unfazed by tariffs

April 25, 2025
By Annette Boyle
First quarter earnings reports from Edwards Lifesciences Corp., Intuitive Surgical Inc. and Boston Scientific Corp. support trends seen earlier: Larger med-tech companies expect substantial tariff hits, but also have confidence that they can absorb the impact with fairly minor adjustments.
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US flag, gavel, book

DOJ rolls out task force for review of burdensome regulation

April 25, 2025
By Mark McCarty
The U.S. Department of Justice recently announced the formation of a task force that will advocate the roll-back of regulations that affect a wide swath of sectors of the American economy. Health care is one of the areas of interest for the task force, which will examine state as well as federal regulations.
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Drug vials and syringe

Vaccine Integrity Project launched to tackle ‘unfortunate reality’

April 25, 2025
By Nuala Moran
Nervousness about the Trump administration’s attitude to vaccines has spurred the formation of the Vaccine Integrity Project, which has the aim of safeguarding the use of vaccines and ensuring vaccine policy “remains grounded in the best available science,” and is “free from external influence.”
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Meeting illustration

Clarification: Nonvoting industry adcom members still possible

April 24, 2025
By Mari Serebrov
In all practicality, U.S. FDA Commissioner Marty Makary’s recently announced policy directive removing industry representatives from the agency’s advisory committees may have little effect on the makeup of the drugs and devices committees, which typically include them as nonvoting members.
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China in red on globe
Chinabio 2025

US capital crunch pushes China biotechs to roundabout financings

April 24, 2025
By Marian (YoonJee) Chu
Tightening of U.S. regulation and capital is leading Chinese biotechs to alternative and new models of financing, ranging from cross-border licensing deals, M&As, the so-called newco model and overseas listings.
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Laptop displaying FDA logo

MDMA’s Leahey skeptical of reports of the demise of user fees

April 23, 2025
By Mark McCarty
Staffing cuts at the FDA’s device center led to speculation that the current user fee program may be fatally damaged, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association, said in a meeting in Columbus, Ohio that there are too many resources for FDA at stake for the user fee program to be ended.
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US FDA reduction-in-force delays response to Vanda

April 23, 2025
By Mari Serebrov
A U.S. FDA CDER official is among the first to say the quiet part out loud in proposing a Sept. 12 deadline for the agency to respond to Vanda Pharmaceuticals Inc.’s request for summary judgment or a hearing on CDER’s refusal to approve tradipitant to treat gastroparesis.
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Handshake with digital globe overlay

Chinabio 2025: Europe-China pharma deals rise as US markets shut

April 23, 2025
By Marian (YoonJee) Chu
Europe was a bigger counterpart to China in pharmaceutical dealmaking than the U.S. last year, speakers at Chinabio Partnering Forum said April 23, and the trend is likely to continue in 2025 with the shuttering of U.S. capital and volatility ailing global markets.
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Female healthcare professional holding health icon

US HHS axes women’s health research

April 23, 2025
By Anette Breindl
On Jan. 21, economist Jay Bhattacharya spoke publicly for the first time since becoming the current NIH director, addressing the NIH Council of Councils in an open session. The goal of Bhattacharya’s remarks seemed to be to reassure troubled staffers. His reassurances, however, were given in the face of another blow to NIH research.
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