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Home » Topics » Regulatory

Regulatory
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Koreabio Humanase KOH Sungho
Bio Korea 2025

FDA shift from animal testing fuels organoid, organ-on-chip demand

May 13, 2025
By Marian (YoonJee) Chu
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.
Read More
Product recall concept image

FDA warns ICU Medical for fixes for infusion pump

May 13, 2025
By Mark McCarty
The U.S. FDA’s April 4, 2025, warning letter to ICU Medical Inc. cited the company for failure to file a new 510(k) for changes to software used in an infusion pump, but those changes may have been driven by problems with the pumps the company acquired when it picked up Smiths Medical in 2022. The FDA also issued a warning letter to Epicare Acquisitions LLC related to its Zenith family of laser hair removal systems.
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Speech bubbles

HHS asks for input on which regs to kill

May 13, 2025
By Mari Serebrov
No Comments
As the U.S. Department of Health and Human Services (HHS) and its agencies begin weeding out old regulations, the department is requesting public input to help identify and eliminate outdated or unnecessary regulations.
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US lawmakers call for action in addressing PBM practices

May 13, 2025
By Mari Serebrov
No Comments
In a continuing déjà vu, the Senate Judiciary Committee held yet another hearing May 13 on pharmacy benefit managers (PBMs), focusing on a lack of transparency.
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Trump tariff EO signing

South Korea urges US to exempt pharma, allies from tariffs

May 13, 2025
By Marian (YoonJee) Chu
No Comments
South Korean government and biopharmaceutical industry representatives urged American policymakers May 7 to refrain from imposing tariffs on pharmaceutical imports, and to spare allies if pharma tariffs are deemed necessary. Both Korea’s Ministry of Health and Welfare on May 4 and the Korea Biotechnology Industry Organization on May 6 submitted comments to the U.S. Department of Commerce in response to its ongoing investigation of pharmaceutical imports.
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Jorge A. Goldstein at Bio Korea 2025
Bio Korea 2025

US legal issues to track in pharma, biotech

May 13, 2025
By Marian (YoonJee) Chu
No Comments
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
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Illustration of Won currency, graph, up arrows

Korea pharma stocks rally; Celltrion welcomes US drug pricing

May 13, 2025
By Marian (YoonJee) Chu
No Comments
Korean pharmaceutical stocks rose across the board May 13, a day after U.S. President Donald Trump signed off on the most favored nation executive order, a drug pricing policy expected to benefit biosimilar makers in the U.S., according to Celltrion Inc.
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Disitamab vedotin

China’s NMPA gives thumbs up to Remegen’s ADC targeting HER2

May 13, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration has approved Remegen Co. Ltd.’s antibody-drug conjugate (ADC), disitamab vedotin (RC-48), for treatment of HER2-positive advanced breast cancer in patients with liver metastasis.
Read More

Trump tariffs trigger US capital commitments

May 13, 2025
By Amanda Lanier
No Comments
A number of biopharma and med-tech companies are committing to expand manufacturing and other facilities in the U.S. Some shifts could be driven by the tariffs imposed by President Trump in 2025, signaling a strategic move to mitigate costs and ensure continued growth
Read More
3D illustration showing DNA inside adenovirus
Neurology/psychiatric

IND clearance for Mavrix Bio’s AAV gene therapy for Angelman syndrome

May 13, 2025
No Comments
Mavrix Bio has received IND clearance from the FDA for MVX-220, an investigational AAV gene therapy for the treatment of Angelman syndrome. The company expects to initiate its first-in-human study, ASCEND-AS, in the second half of this year.
Read More
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