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.

Three milestones expected to bring the reality of U.S. prescription drug price negotiations into focus are hovering on the horizon. First, the CMS is scheduled to publish its maximum fair prices (MFPs) for the round 2 selected drugs by Nov. 30. Then, on Jan. 1, the MFPs for the first round kick in, affecting not only the 10 selected drugs, but a dozen approved biosimilars referencing the three biologics in that round, 94 generics either approved or tentatively approved that reference the small molecules on the list, and perhaps other innovator drugs in the same therapeutic spaces. And by Feb. 1, CMS must publish the list of up to 15 drugs selected for negotiations for the 2028 price year. That list will be the first to include Part B drugs.

The U.S. Department of Health and Human Services reported Aug. 27 that Susan Monarez no longer occupies the post of director for the CDC, a development that arose within hours of the FDA’s approval of two COVID-19 vaccines with historically restrictive labeled indications.

Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).

Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.

A few years after it was founded with the aim of taking RNA therapies to the next level, Arnatar Therapeutics Inc. emerged from stealth, disclosing a $52 million series A round raised in 2024 as well as U.S. FDA orphan and rare pediatric disease designations for ART-4, an antisense oligonucleotide candidate targeting the root cause of Alagille syndrome.

Worrisome new signals caused the U.S. FDA – which earlier this month OK’d revised labeling for Valneva SE’s chikungunya virus vaccine Ixchiq – to suspend the product’s license altogether. Regulators pointed to four added reports of serious adverse events consistent with chikungunya-like illness, and told Valneva, of Saint Herblain, France, that the company must stop U.S. shipping and sales of the product. Shares (NASDAQ:VALN) closed Aug. 25 at $9.43, down $2.21, or 19%.

On Thursday, the Supreme Court handed the Trump administration another significant victory in its attempts to defund NIH-sponsored research. In a 5-4 decision, the justices paused the June 16 order of U.S. District Judge William Young to restore funding for hundreds of canceled NIH research grants focusing on gender and diversity, equity and inclusion (DEI). The funding had first been cut through a series of executive orders shortly after President Donald Trump resumed power in January.