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. Read More
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. Read More
Already in the headlines plenty for their apparently broad set of benefits for patients, glucagon-like peptide 1 receptor agonists notched worth in yet another indication: hidradenitis suppurativa, the skin disease of interest to plenty of biopharma drug developers. Read More
The Korea Pharmaceutical Traders Association said Aug. 26 that it signed a strategic agreement with Korea Trade Insurance Corp. to support South Korean companies exporting biopharmaceutical materials overseas. Read More
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. Read More
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. Read More
Antiva Biosciences Inc. has developed an intravaginal topical treatment, ABI-2280, for high-risk cervical infections with human papillomavirus (HPV). In a phase Ib/II study, after two weeks of treatment at the highest dose of the DNA polymerase inhibitor, 46% of patients were negative for high-risk HPV at week 12, compared to just 16% of patients treated with placebo. Read More
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. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Cytomed, Flagship, Indivior, Iqvia, Junshi, Lakeshore, Treos. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Aldeyra, Biontech, D3 Bio, Moderna, Novavax, Outlook, Pfizer, Teva, Tolremo, Travere, Vanda. Read More
