An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.

The latest figures on uptake of rivals to AbbVie's Humira in the US show adalimumab biosimilars beginning to capture significant market share from the originator after an initially slow start in 2023.

The agency is also poised to announce another development in its scrutiny of the drug patents listed in the FDA’s Orange Book.

Medicines are still typically prescribed based on average effects in a population and rarely dose-optimized for the individual, says Closed Loop Medicine. The company sees a new strategic partnership with Teva UK as another step in advancing personalized medicine.