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BioWorld - Thursday, December 11, 2025
Home » Topics » Regulatory » Policy

Policy
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Monarez gives her side of how she was fired from the CDC

Sep. 17, 2025
By Mari Serebrov
No Comments
For enquiring minds that want to know, Susan Monarez laid out the details Sept. 17 of how she was fired as CDC director for the Senate Health, Education, Labor and Pensions Committee.
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Susan Monarez speaks at Senate HELP hearing

ACIP meeting cause for consternation at US Senate hearing

Sep. 17, 2025
By Mari Serebrov
No Comments
The Sept. 17 U.S. Senate Health, Education, Labor and Pensions Committee hearing on the CDC is throwing even more shade on the upcoming meeting of the agency’s reconstituted Advisory Committee for Immunization Practices (ACIP), which is expected to recommend changes to the childhood vaccine schedule.
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China in red on globe
Bio Hong Kong 2025

US chaos positions China as more dependable leader

Sep. 16, 2025
By Tamra Sami
No Comments
China was already making strides to lead the biotechnology industry in many key areas such as cell therapies and AI, but the chaotic nature of the Trump administration and the turmoil in the U.S. has catapulted China’s status as a more “dependable” partner, presenters said during the Bio Hong Kong conference, Sept. 10 to 13.
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Kim Kyung-ah, CEO, Samsung Bioepis

South Korea to hike biosimilar approval fees, slash review times

Sep. 16, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.
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Halt of biopharma investment prompts emergency UK hearing

Sep. 16, 2025
By Nuala Moran
No Comments
The U.K.’s failure to join the dots from discovery research to patient access to innovative drugs was cited repeatedly by pharma leaders, who were called to an emergency hearing in parliament on Tuesday to explain decisions to pull out of promised capital investments.
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Empty conference room

Advisory committee meetings becoming a rarity at the FDA?

Sep. 16, 2025
By Mari Serebrov
No Comments
Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by the numbers.
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Kim Kyung-ah, CEO, Samsung Bioepis

South Korea to hike biosimilar approval fees, slash review times

Sep. 15, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.
Read More
Teen receiving vaccine

US CDC, ACIP in spotlight, pertussis outbreak threatens Louisiana

Sep. 15, 2025
By Mari Serebrov
No Comments
Just three days before the U.S. CDC’s reconstituted Advisory Committee for Immunization Practices (ACIP) is scheduled to discuss and possibly vote on the COVID-19, hepatitis B and MMRV vaccines, Health and Human Services Secretary Robert Kennedy added five new members to the panel.
Read More
China in red on globe
Bio Hong Kong 2025

US chaos positions China as more dependable leader

Sep. 12, 2025
By Tamra Sami
No Comments
China was already making strides to lead the biotechnology industry in many key areas such as cell therapies and AI, but the chaotic nature of the Trump administration and the turmoil in the U.S. has catapulted China’s status as a more “dependable” partner, presenters said during the Bio Hong Kong conference, Sept. 10 to 13.
Read More
Pills in the foreground, TV ad for drugs in the background

US FDA cracking down on prescription drug ads

Sep. 11, 2025
By Mari Serebrov
No Comments
It took a memo from the president for the U.S. FDA to begin reining in direct-to-consumer prescription drug advertising with its feel-good messaging and hurried recitation of a few serious adverse events.
Read More
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