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.

Medtronic plc received U.S. FDA approval for the expanded redo TAVR indication of the Evolut transcatheter aortic valve replacement system. The approval allows for valve-in-valve implantation of a new Evolut valve inside a failed previously implanted TAV made by any manufacturer in patients with severe aortic stenosis considered high-risk for open-heart surgery.

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).

Twenty-two years since its formation, Bioarctic AB expects to become profitable in 2025, as milestones for marketing approvals and royalties on sales of the Alzheimer’s drug Leqembi (lecanemab) roll in, and partners sign up to use its proprietary Braintransporter drug delivery technology.

Leal Therapeutics Inc. is taking advantage of new genetic data that suggest products from metabolic pathways are involved in psychiatric and neurodegenerative diseases.

Billiontoone Inc.’s Northstar Select comprehensive genomic profiling liquid biopsy assay identified more treatable variants than other tumor profiling platforms in a study published in The Journal of Liquid Biopsy. Notably, the test found clinically actionable alterations substantially below the limit of detection for other tests.

Iantrek Inc. reported the close of a $42 million series C financing round, which it said will facilitate the U.S. commercial launch of its Alloflo Uveo, a bio-interventional ophthalmic surgery solution targeting the lightly used uveoscleral pathway, as well as broader pipeline expansion.

The U.S. FDA’s draft guidance for package labeling recommendations for hernia mesh products did not draw a large volume of comments, but the Medical Device Manufacturers Association advised the agency that the information disclosed on package labels should be limited as the package is often too small to provide adequate readable information.