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BioWorld - Wednesday, April 8, 2026
Home » Topics » Regulatory » Policy

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Wegovy and Zepbound autoinjectors

Lilly, Novo MFN deals expected to ‘democratize’ obesity drugs

Nov. 6, 2025
By Mari Serebrov
No Comments
Hailing it as a win-win and a historic step forward in fighting chronic disease, the Trump administration announced pricing agreements Nov. 6 with Eli Lilly and Co. and Novo Nordisk A/S that will expand the availability of the companies’ weight loss drugs by cutting prices and, for the first time, providing coverage for the drugs in obesity through Medicare and Medicaid.
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U.S. President Donald J. Trump (left) and South Korea President Lee Jae-myung at the ROK-U.S. summit

South Korea trade deal eases industry’s pharma tariff fears

Nov. 4, 2025
By Marian (YoonJee) Chu
No Comments
The Korea Biotechnology Industry Organization on Oct. 30 welcomed the bilateral trade deal between the U.S. and South Korea announced during U.S. President Donald Trump’s state visit alongside the Asia-Pacific Economic Cooperation forum in Gyeongju, South Korea.
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Pill, syringe, ampoules on US flag

Is US about to cede biotech leadership role?

Oct. 30, 2025
By Mari Serebrov
No Comments
John Crowley doesn’t worry about where his kids’ toys are made, but he told the Senate Health, Education, Labor and Pensions Committee that he does care where their medicines are made. His concerns, as a father and as president/CEO of the Biotechnology Innovation Organization, are becoming more urgent, he testified at an Oct. 29 HELP hearing on the future of biotech in the U.S.
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U.S. President Donald J. Trump (left) and South Korea President Lee Jae-myung at the ROK-U.S. summit

US, South Korea trade deal eases industry’s pharma tariff fears

Oct. 30, 2025
By Marian (YoonJee) Chu
No Comments
The Korea Biotechnology Industry Organization on Oct. 30 welcomed the bilateral trade deal between the U.S. and South Korea announced during U.S. President Donald Trump’s state visit alongside the Asia-Pacific Economic Cooperation forum in Gyeongju, South Korea.
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Collection of vials

US FDA paves way for biosimilars to be more like generics

Oct. 29, 2025
By Mari Serebrov
No Comments
Ten years after the first biosimilar launched on the U.S. market, the FDA is taking steps to make biosimilar development and pharmacy substitution more like that of generics, reducing the cost of the drugs in the process. “We want to see more biosimilars. We want to see more competition,” FDA Commissioner Marty Makary said at an Oct. 29 media briefing in which he announced new guidance to streamline biosimilar development, cut through the red tape and shorten the timeline.
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Stem cells
BIX 2025

Opportunity, risks of cell therapy to tackle aging and disease

Oct. 28, 2025
By Marian (YoonJee) Chu
No Comments
Stem cells are a promising therapeutic modality to fight aging and age-related disease, speakers at the Bio-Plus Interphex Korea 2025 said. Progress in cell-based longevity medicine is being made, they added, although safety, ethical and regulatory issues are ongoing challenges.
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Stem cells
BIX 2025

Opportunity, risks of cell therapy to tackle aging and disease

Oct. 23, 2025
By Marian (YoonJee) Chu
No Comments
Stem cells are a promising therapeutic modality to fight aging and age-related disease, speakers at the Bio-Plus Interphex Korea 2025 said. Progress in cell-based longevity medicine is being made, they added, although safety, ethical and regulatory issues are ongoing challenges.
Read More
Wooden blocks spelling TARIFFS with a U.S. flag on top, placed on a map of Europe

Trade associations push back on Trump Section 232 review

Oct. 21, 2025
By Mark McCarty
The Trump administration’s consideration of a new round of tariffs has prompted two major med-tech trade association to advise the White House to leave medical consumables and medical devices out of any new tariffs, citing concerns about the impact on patient care.
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World with digital overlay

BIX 2025: What ‘radical’ changes in US, China mean for bio sector

Oct. 21, 2025
By Marian (YoonJee) Chu
No Comments
Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.
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Capsules and tablets scattered over a world map

MFN drug pricing getting a foothold in the US

Oct. 17, 2025
By Mari Serebrov
No Comments
Caught between the rock and the hard place of most-favored nation (MFN) pricing and the threat of a hefty biopharma sector tariff, drug companies marketing in the U.S. are exploring their options. Several large firms already have committed millions and billions of dollars in investment in new or expanded U.S.-based manufacturing facilities to avoid tariffs on finished drugs.
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