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.

Aging researchers see no cause for joy as O’Neill helms CDC

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. Increasing healthy lifespan is a worthy goal for a public health agency, and under normal circumstances, the appointment of an official with an interest in anti-aging strategy would be cause for celebration. But at the 12th Aging Research & Drug Discovery Meeting, which is being held this week in Copenhagen, the opposite was the case.

‘Jury out’ on what’s next as hidradenitis suppurativa evolves

Already in the headlines plenty for their apparently broad set of benefits for patients, glucagon-like peptide 1 (GLP-1) receptor agonists notched worth in yet another indication: hidradenitis suppurativa, the skin disease of interest to plenty of biopharma drug developers. According to a paper published in the Journal of the American Medical Association, research by investigators in the department of dermatology at the Rennes University Hospital in France and others found, not surprisingly, that GLP-1s showed particular upside in obese HS patients, probably because of the weight-loss properties for which the class is widely hailed.

Korea pharma group to support exports, Korea-Japan-China trade

The Korea Pharmaceutical Traders Association said Aug. 26 that it signed a strategic agreement with Korea Trade Insurance Corp. (K-Sure) to support South Korean companies exporting biopharmaceutical materials overseas. A key initiative of the agreement will be to provide domestic pharmaceutical and biotechnology companies “group insurance” when selling to overseas markets. Under the terms, K-Sure agreed to provide insurance for all member companies by procuring export contracts “in bulk” to hedge against the risk of non-payment of goods by international buyers. The memorandum of understanding is designed to support the “steady increase” in biopharmaceutical exports and expand opportunities for Korean companies overseas, according to the groups.

Cancer cells shown to export mitochondria to reprogram fibroblasts

Mitochondrial transfer is known to occur from the tumor microenvironment into cancer cells, but now, Swiss researchers have shown a possible precursor to this is that cancer cells smuggle their mitochondria into healthy connective tissue cells, prompting their reprogramming to cancer-associated fibroblasts. The trafficking protein, mitochondrial Rho GTPase 2 (MIR02) was found to play a pivotal role in this process. When MIR02 was inhibited in vitro and in mouse models, mitochondrial transfer from cancer cells ceased, and fibroblasts were not transformed, suggesting MIR02 could be a drug target.

ARDD 2025: Hitting rewind, not reset, for in vivo rejuvenation

At the 12th Aging Research & Drug Discovery (ARDD) Meeting, which is being held this week in Copenhagen, Life Biosciences Inc. announced that it is developing its partial epigenetic reprogramming technology for liver disease as well as optic neuropathies. The company’s chief scientific officer Sharon Rosenzweig-Lipson estimated that its ER-100 would enter clinical trials in early 2026, putting it on track to be the first application of partial epigenetic reprogramming to enter the clinic. And Altos Labs Inc. founding scientist and senior vice president Juan Carlos Izpisua Belmonte introduced the concept of “mesenchymal drift,” as a targetable form of epigenetic aging, and described Altos’ plans to use partial reprogramming to rejuvenate organs for transplantation.

BioWorld Insider podcast: Bioxcel closer to an sNDA for Igalmi

Bioxcel Therapeutics Inc.’s phase III results in bipolar disorders or schizophrenia could bring Igalmi out of the clinic and into patients’ homes for easier treatment. Vimal Mehta, Bioxcel CEO, talks about the potential with BioWorld’s Lee Landenberger.

Holiday notice

BioWorld's offices will be closed in observance of Labor Day in the U.S. No issue will be published Monday, Sept. 1.

Also in the news

Aldeyra, Ascletis, Biontech, Cel-Sci, Cognition, Cytomed, D3 Bio, Flagship, Indivior, Iqvia, Junshi, Karolinska, Lakeshore, Moderna, Modus, Novavax, Outlook, Pfizer, Plexium, Prothena, Teva, Tolremo, Travere, Treos, Vanda