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.
G2Gbio Inc. debuted on the Korea Exchange with a ₩52.2 billion (US$37.7 million) IPO Aug. 14. Nearly half of the funds raised will be used to expand Cheongju-si, South Korea-based G2Gbio’s manufacturing plants and help mass produce sustained-release injectable drug products such as GB-5001, its lead candidate in development as a once-monthly formulation of donepezil (Aricept; Eisai Co. Ltd.) for Alzheimer’s disease.
Elysium Therapeutics Inc. aims to tackle the problem of opioid overdose with a longer-lasting rescue agent that gets around the not-much-publicized problem of fentanyl rebound, or re-narcotization, which happens when the standard reverser wears off and the culprit drug stays active in the body, potentially killing the patient.