Korea Regulatory Shake Up: President-elect To Upgrade FDA Status, Downgrade Health Ministry
This article was originally published in PharmAsia News
The proposal would expand KFDA’s regulatory oversight powers, despite pushback from the health ministry.
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SEOUL - South Korean President Lee Myung-bak named "17 new growth engines" at a science and technology council meeting at his office in Seoul Jan. 13. Expected to spearhead the country's economic growth for the next 10 years, of those 17 economic growth engines, the Korean government targeted biologics, medical devices and global health care among the national priorities
Multiple IPF drugs are being rushed into Phase III based on early-stage signals of efficacy and safety presented at the ATS meeting. Scrip spoke with the University of Pittsburgh's Kevin Gibson about the candidates, trial design, combination therapy and limitations of current therapy.
Phase III studies testing Dupixent in moderate-to-severe asthma were largely positive, but subgroup details raise questions about how it will compete against biologics targeting the IL-5 pathway. Some experts urge comparison trials to inform physicians' decisions about long-term use.