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BioWorld - Sunday, May 31, 2026
Home » Topics » Regulatory » Legislation

Legislation
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U.S. flag and money

US FTC meets reality on budget request amid overreach concerns

May 15, 2024
By Mari Serebrov
The FTC’s request for a nearly 25% increase in funding for fiscal 2025 was splashed with cold water May 15 in a U.S. House Appropriations subcommittee hearing. That’s “a dramatic increase in funding for an agency whose work continues to raise concerns among many members of Congress and the public,” Rep. David Joyce (R-Ohio), chair of the Subcommittee on Financial Services and General Government, said as he opened the hearing.
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Biosecure Act fine-tuned, new health care tariffs in the offing

May 14, 2024
As it gets fine-tuned, the Biosecure Act is becoming more than just a topic of conversation in the halls and meeting rooms of the U.S. Capitol. Reps. Brad Wenstrup (R-Ohio) and Raja Krishnamoorthi (D-Ill.) formally introduced a new version of the Biosecure Act in the House May 10 as a defense against China’s national security laws requiring all Chinese firms to share any requested data with the Chinese Communist Party, including biotechnology companies that collect, test and store American genomic data.
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NIH researcher looking through a microscope

Sen. Cassidy calls for NIH reforms, questions US ROI

May 13, 2024
By Mari Serebrov
Is the U.S. getting the best return on investment (ROI) for its NIH buck? That’s the basic question at the heart of a white paper Sen. Bill Cassidy (R-La.) issued May 9 to continue a conversation he started in September on the reforms needed at the country’s premier biomedical research institution.
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Dollar sign, downward arrow

Regulatory stresses, interest rates a continuing drag

May 2, 2024
By Mari Serebrov
By now, the story of last year’s dismal U.S. capital markets is hardly news. But when combined with increasing regulatory stresses, especially for biopharma and med-tech startups, there are elements of that story giving some Street-watchers pause, even as the market begins to show a few signs of recovery.
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Needle with drop

Alvotech-Teva biosimilar approved, impact of negotiations looms

April 17, 2024
By Mari Serebrov
Having addressed the manufacturing issues that resulted in a few complete response letters, Alvotech Holdings SA and Teva Pharmaceutical Industries Ltd.’s biosimilars partnership is now on a roll, with the U.S. FDA approving the team’s second biosimilar, Selarsdi, less than two months after approving the first one, Simlandi, as an adalimumab interchangeable.
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Sanders proposes $10B more in NIH long COVID research

April 9, 2024
By Mari Serebrov
Before formally introducing legislation to spur R&D of treatments for long COVID, the U.S. Senate Health, Education, Labor and Pensions Committee is calling for stakeholder input on the proposal that would require $10 billion in dedicated, mandatory NIH funding to respond to the chronic condition over the next 10 years.
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Senate presses HHS on data breach that cost $7.5M

March 26, 2024
By Mark McCarty
The U.S. Department of Health and Human Services (HHS) was quite vocal in its statement regarding a recent hospital cybersecurity breach, but HHS recently suffered an undisclosed data breach that cost $7.5 million in taxpayer monies.
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Zepbound

US CBO: Numbers don’t add up yet for Part D obesity drug coverage

March 22, 2024
By Mari Serebrov
When it comes to whether Medicare Part D should cover the new anti-obesity drugs, the U.S. Centers for Medicare & Medicaid Services and lawmakers may be caught between the math and public pressure.
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US senators: Want lower drug prices? Reform PBMs

March 20, 2024
By Mari Serebrov
Although there’s bipartisan interest in the U.S. Congress to hold pharmacy benefit managers (PBMs) accountable for their contribution to the costliest drug prices in the world, the Biden administration ignored PBMs when it again focused on drug companies as the bad guys of pricing in its proposed 2025 budget.
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EU flags

EU’s largest pharma reform in 20+ years advances, despite concerns

March 20, 2024
By Nuala Moran
After months of wrangling, the update of the EU pharmaceutical legislation passed an important milestone on March 19, when members of parliament on the health committee reconciled their opposing views and voted the file through.
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