The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about related compliance activities.

The end of the year will be the end of an era at the FDA, as Bob Temple shuts his door at CDER for the last time Dec. 31. After more than half a century at the FDA’s drug center, Temple has become the backbone of CDER’s new drug program, providing expertise and stability as other personnel have come and gone.

AI-powered drug R&D platform firm Oncocross Co. Ltd. is leading the procession of year-end Korea biotech IPOs this week, pricing an offering of about 11.85 million shares on the Korea Exchange at ₩7,300 each for gross proceeds of ₩85.56 billion (US$59.5 million).

With no time to spare, the U.S. Congress is coming together on a continuing resolution (CR) to keep the federal government running beyond Dec. 20. Intended to fund the government at current levels through March 14, the CR itself is temporary. But of the 1,500-plus pages in the package House leadership released late Dec. 17, only about 100 pages pertain to the actual CR. More than a third of the package is devoted to the health-care sector.

Researchers at the University of Leipzig and ETH Zurich have used single-cell sequencing to identify differences between fat tissue of obese individuals who are metabolically unhealthy, and those who were in good metabolic health. The findings, which were published online Dec. 17, 2024, in Cell Metabolism, identify measurements that can be used to decouple obesity from metabolic disease.

SK Biopharmaceuticals Co. Ltd. and Proen Therapeutics Co. Ltd. joined hands in a research collaboration to advance up to two preclinical small protein-based radiopharmaceuticals by 2027 – the year SK Biopharmaceuticals aims to “become a leading radiopharma player” worldwide.