The U.S. Food and Drug Administration has tentatively approved Dr. Reddy’s Laboratories to make a generic version of a groundbreaking HIV prevention medicine. The decision is an important step toward expanding access in dozens of low- and middle-income countries, STAT reported.
Dr. Reddy’s, one of the world’s largest generic drugmakers, plans to start shipping the medicine next month. The effort has been supported in part by global health organizations seeking to make the drug available in lower-income countries as quickly as possible. The annual cost is expected to be $40 per person, comparable to the cost of daily tablets.
Separately, contract drug manufacturer Lonza has agreed to buy five U.S. manufacturing sites from Merck KGaA, Reuters reported. The deal will more than double Lonza’s U.S. footprint and expand its capacity to produce advanced cancer and gene therapies. The sites are in Missouri, Wisconsin, Indiana and California.
The acquisition will bring Lonza’s U.S. site count to nine, while allowing Germany-based Merck to focus more closely on drug development. Lonza has been expanding its U.S. contract manufacturing network through acquisitions, including Roche’s biologics plant in Vacaville, California, in 2024.
Sources: STAT News.