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BioWorld - Friday, April 10, 2026
Home » Topics » Regulatory » Policy

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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.
Read More
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.
Read More

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.
Read More
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
Vaccine vial and syringe

Kennedy: All US vaccines to be reviewed

Sep. 10, 2025
By Mari Serebrov
No Comments
Speaking at a Sept. 9 media briefing on the newly released Make America Healthy Again Strategy, U.S. Health and Human Services Secretary Robert Kennedy confirmed what could be the worst fears of many vaccine experts.
Read More
Pills in the foreground, TV ad for drugs in the background

US FDA cracking down on prescription drug ads

Sep. 10, 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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