The unsettling impact that the Trump administration’s health care and tariff initiatives are having on M&A activity and financing is highlighted in a new survey of CEOs and investors, who say uncertainty related to the U.S. policy environment is the top challenge they face when it comes to executing deals.
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.
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.
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.
Less than two months after receiving priority review status for an NDA, Johnson & Johnson won U.S. FDA approval of Inlexzo, its intravesical gemcitabine-releasing system previously known as TAR-200, to treat adults with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.
The U.S. Federal Trade Commission has opened a docket for comment on noncompete employment contracts, a move which suggests that the agency may revert to evaluating these practices on a case-by-case basis rather than by issuing sweeping rules.
Sparks flew both ways Sept. 4 as Democratic senators pushed for Robert Kennedy to resign as secretary of the U.S. Department of Health and Human Services (HHS) during a Senate Finance Committee hearing ostensibly held to discuss the Trump administration’s 2026 health care agenda. But with Kennedy the only witness, the hearing focused on Kennedy’s perceived failings as HHS secretary. “The United States is in the midst of a health care calamity,” Ranking Member Ron Wyden, D-Ore., said in his opening comments, which were laden with personal attacks.
Two days after the ouster of Susan Monarez as CDC director on Aug. 27, HHS confirmed to BioWorld that James O’Neill is serving as acting director. O’Neill was previously Deputy Secretary of Health and Human Services. He has also served as the CEO of the SENS Research Foundation, which merged with Lifespan.io in 2024. The resulting Lifespan Research Institute describes itself as “focused on the defeat of age-related disease and the extension of healthy human lifespan” on its website.
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