First-time generic approvals, July 2007

Aucatzyl is a CAR T-cell therapy that targets CD19 and has been designed to minimize excessive activation of the programmed T cells. There is no word yet on the wholesale acquisition cost.

In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.

An FDA advisory committee last year agreed that the data do not support phenylephrine as an effective nasal decongestant.

If approved, donidalorsen would be a first-in-class RNA-targeted medicine for hereditary angioedema. The agency’s goal date is August 21, 2025.

In the ESSENCE trial, semaglutide improved liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH).

Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.