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BioWorld - Monday, August 3, 2026
Home » Topics » Regulatory » Legislation

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U.S. Capitol building

US Senate greenlights bill to tame biologic patent thickets

July 22, 2026
By Mari Serebrov
No Comments
After languishing on the U.S. Senate floor for more than a year, the Affordable Prescriptions for Patients Act (S. 1041) finally got a unanimous vote July 21 and is now on its way to the House, again. Aimed at reining in patent thickets, the bill limits the number of patents a biologics sponsor can assert against a biosimilar when engaging in the voluntary “patent dance” laid out in the Biologics Price Competition and Innovation Act. The number is no more than 20 patents, a limit the bill’s bipartisan sponsors called “reasonable.”
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U.S. flag, stethoscope

Bipartisan health bills get passing vote in US House

July 21, 2026
By Mari Serebrov
No Comments
In a rapid-fire voting session, the U.S. House suspended the rules July 20 to pass, by voice vote, a slate of bipartisan health bills ranging from reducing animal testing in drug development to clarifying Medicare coverage of wheelchairs.
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CLIA regs may be in for an update

July 16, 2026
By Mari Serebrov
No Comments
Citing the significant advancements made in lab testing technologies since the Clinical Laboratory Improvement Amendments (CLIA) were enacted nearly 40 years ago, the U.S. CDC and Center for Medicare and Medicaid Services are considering updating the regulations to reflect today’s technology.
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U.S. Capitol building

US primaries continue to rattle congressional health leadership

July 1, 2026
By Mari Serebrov
No Comments
Regardless of whether the Republicans or Democrats come out on top in November’s midterm congressional elections, some of the state primaries in the U.S. have already guaranteed major shuffles in key House and Senate committees overseeing national health issues.
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China U.S. deal

Competitive approach better than restricting deals with China?

June 9, 2026
By Mari Serebrov
No Comments
The recent introduction of the bipartisan Biotech Investment National Security Act in the U.S. House has industry and venture capitalists urging lawmakers to take a breath, step back, and consider a less invasive approach than restricting U.S. biopharma deals with Chinese innovators.
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Wuxi Apptec signage

Wuxi Apptec insists it’s ‘not a Chinese military company’

June 9, 2026
By Mari Serebrov
No Comments
Wuxi Apptec isn’t going down without a fight after the U.S. Department of Defense added it to the Section 1260H list June 8 as a designated “Chinese military company,” which makes it a “biotechnology company of concern” under the Biosecure Act. “Such designation is mistaken and baseless,” the global contract research, development and manufacturing organization said in an open letter to its life sciences partners. “We will pursue every available avenue to correct this mistake.” That includes appealing the designation.
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China U.S. deal

Competitive approach better than restricting deals with China?

June 8, 2026
By Mari Serebrov
No Comments
The recent introduction of the bipartisan Biotech Investment National Security Act in the U.S. House has industry and venture capitalists urging lawmakers to take a breath, step back, and consider a less invasive approach than restricting U.S. biopharma deals with Chinese innovators.
Read More
U.S. Capitol building

BMS-Hengrui deal strikes panic in Washington

June 2, 2026
By Tamra Sami
No Comments
On the heels of the multibillion-dollar licensing deal between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd., Chairman John Moolenaar (R-MI), of the House Select Committee on the Chinese Communist Party, sent a letter to Treasury Secretary Scott Bessent urging him to add biotechnology as a prohibited technology under the Comprehensive Outbound Investment National Security (COINS) Act of 2025.
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U.S. Capitol building
Policy

BMS-Hengrui deal strikes panic in Washington

May 29, 2026
By Tamra Sami
No Comments
On the heels of the multibillion-dollar licensing deal between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd., Chairman John Moolenaar (R-MI), of the House Select Committee on the Chinese Communist Party, sent a letter to Treasury Secretary Scott Bessent urging him to add biotechnology as a prohibited technology under the Comprehensive Outbound Investment National Security (COINS) Act of 2025.
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U.S. Capitol building

BMS-Hengrui deal strikes panic in Washington

May 27, 2026
By Tamra Sami
No Comments
On the heels of the multibillion-dollar licensing deal between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd., Chairman John Moolenaar (R-MI), of the House Select Committee on the Chinese Communist Party, sent a letter to Treasury Secretary Scott Bessent urging him to add biotechnology as a prohibited technology under the Comprehensive Outbound Investment National Security (COINS) Act of 2025.
Read More
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