Kaken Pharmaceutical Co. Ltd.’s license agreement with Johnson & Johnson (J&J) for signal transducer and activator of transcription (STAT)6 inhibitor KP-723 could presage further deals in STAT6, where a number of developers are active. Kaken’s arrangement with J&J involves the global development, manufacturing and sale of KP-723, which has reached the preclinical stage. Tokyo-based Kaken will take the drug through phase I trials, after which J&J takes over.
Ausperbio Therapeutics Inc. raised $110 million from two financing rounds in 2024 to advance its lead antisense oligonucleotide candidate as a functional cure for chronic hepatitis B.
Zhongzhi Pharmaceutical Holdings Ltd. made a $3 million investment in a series A financing round of stem cell therapy developer Gabaeron Inc. Dec. 21, expected to help propel Gabaeron’s preclinical Alzheimer’s disease (AD) candidate into phase I testing.
Sangamo Therapeutics Inc.’s stock sank sharply on the last day of 2025 as Pfizer Inc. handed back the rights to their collaborative gene therapy hemophilia A program. While it was another big loss to Sangamo, which had seen two other major deals fall through in the past two years, the company still has two large collaborations in development.
2024 was a critical year for the FDA’s Center for Devices and Radiological Health and included a smooth transition in leadership, but it was not without controversy. The agency triggered not one but two lawsuits over the final rule for regulation of lab-developed tests, a problem that promises to distract the agency throughout 2025 and potentially beyond.
The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about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.
Biontech SE agreed to pay up to nearly $1.26 billion in two separate settlements to resolve royalty disputes with the U.S. NIH and the University of Pennsylvania related to the COVID-19 vaccine the company partnered with Pfizer Inc.
Ausperbio Therapeutics Inc. raised $110 million from two financing rounds in 2024 to advance its lead antisense oligonucleotide candidate as a functional cure for chronic hepatitis B.
Artificial intelligence (AI) is no novelty for medical technology, but 2024 saw an interesting series of events in this area from across the globe. While some of these developments portend immediate regulatory clarity, some are harbingers of continued regulatory flux in 2025 and beyond.
The U.S. FDA has issued a second report in connection with device software functions, which includes surveillance data for clinical decision support (CDS) tools. While the report lists three events that qualify as adverse events, the FDA offered no information that would provide an adverse event rate for CDS products.
RSS
