The U.S. Centers for Medicare & Medicaid Services proposed to use AI to cut down on abuse of the Medicare program, but several members of Congress have concerns about the notion, given that private payers have used AI to illegitimately deny services to their beneficiaries.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Biodlink, Creative Medical, Insmed, Kexing, Ocugen, Savara.
Biopharma happenings, including deals and partnerships, and other news in brief: Abbvie, Apertura, Emugen, Fate, Galibra, Generation Bio, Lixte, NextRNA, Oric, Santhera.
In his latest effort to incentivize domestic manufacturing of drugs and their key ingredients, U.S. President Donald Trump issued an executive order Aug. 13 to replenish the country’s nearly empty Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), giving a preference to U.S.-produced APIs.
Aussie gene therapy company Mirugen Pty Ltd. has emerged from stealth mode from the Center for Eye Research Australia in Melbourne, toting a AU$4.5 million (US$2.9 million) seed round that will see it optimize its lead candidate to treat retinitis pigmentosa.
German researchers have cracked the decades-long mystery of why males are more susceptible to acute kidney injury than females, demonstrating that estrogen has a protective effect in females.