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Regulatory
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Martin Kulldorf, ACIP chair

No vote, ACIP recurring theme at CDC confirmation hearing

June 25, 2025
By Mari Serebrov
No Comments
Although the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) was scheduled to vote June 25 on recommendations for maternal and pediatric respiratory syncytial virus vaccines, it adjourned by pushing that vote to the second day of the meeting. But before leaving for the day, it got an earful of comments from pediatricians, nurses and even a retired FDA scientist urging the CDC to reinstate the 17 committee members Health and Human Services Secretary Robert Kennedy dismissed two weeks earlier and replaced with eight new members.
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Gavel and FTC logo

Xlear presses court to force FTC to drop substantiation requirement

June 24, 2025
By Mark McCarty
Xlear Inc., of Salt Lake City filed a petition in U.S. district court that could terminate the Federal Trade Commission’s practice of demanding substantiation of health care claims.
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US flag and HHS logo

HHS, payers vow to fix prior authorization problem

June 24, 2025
By Mark McCarty
The Department of Health and Human Services and private payers have promised to streamline the controversial prior authorization processes in a bid to reduce the attendant controversies.
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Jyong’s $20M US IPO to help refile NDA of urological botanic drug

June 24, 2025
By Marian (YoonJee) Chu
No Comments
Jyong Biotech Ltd. raised $20 million from its Nasdaq debut June 17 to advance a pipeline of botanical drugs targeting male urinary disorders. The New Taipei City, Taiwan-headquartered company’s shares began trading under the ticker MENS, and closed at $10.11 apiece at the bell, up 34.80% from its listing price of $7.50 per share. Shares had kicked up to $15 at opening, reaching double its offering price.
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FDA icons

FDA scrutinizing trials sending US patient cells to China

June 24, 2025
By Mari Serebrov
No Comments
Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
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No postponement likely for ACIP meeting

June 24, 2025
By Mari Serebrov
No Comments
Barely a day before the eight new members of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) are supposed to hold their first meeting, Sen. Bill Cassidy, R-La., called for the June 25 meeting to be postponed.
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HHS Secretary Robert Kennedy

HHS budget hearing mashup of the worst and the best

June 24, 2025
By Mari Serebrov
No Comments
“I expressed deep concerns with your nomination, Secretary Kennedy, and somehow, unfortunately, you have exceeded my expectations in the worst possible ways,” U.S. Rep. Frank Pallone, D-N.J., told Health and Human Services (HHS) Secretary Robert Kennedy during a June 24 House subcommittee hearing.
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Medicare puzzle

MedPAC sounds alarm over Medicare physician pay rates

June 23, 2025
By Mark McCarty
The Medicare Payment Advisory Commission advised Congress that inflation is taking a bite out of physician pay and Medicare payments may have to increase in order to preserve patient access to care.
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Art concept for gene therapy research

Deepecho secures FDA clearance for fetal imaging platform

June 23, 2025
By Shani Alexander
Deepecho Inc. received the U.S. FDA’s nod for its AI-based platform that assesses fetal biometry and amniotic fluid volume to improve the efficiency and precision of fetal ultrasound diagnostics.
Read More
MHRA logo

UK’s MHRA opens second round in AI airlock program

June 23, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency opened a second round in its AI airlock program although this round, like the first round, will be limited to four applicants.
Read More
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