South Korea’s first approved gene therapy has been suspended from sale in the country, while recruitment in an ongoing US Phase III program has been temporarily halted, after findings that an active cell component may differ from the data submitted at the time of approval. While both manufacturer and regulator see no safety risk, results from an official Korean probe are due in mid-April.

US FDA says as artificial intelligence and machine learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors. It also released a discussion paper outlining key issues it wants feedback on from industry and other key stakeholders.

A roundup of recent medtech mergers & acquisitions, strategic alliances, and financings.

The Dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, pharmaceuticals, medical devices, and research/analytical instrumentation and reagents. All transactions are excerpted from Elsevier's Strategic Transactions database, providing comprehensive transaction coverage from 1991 to the present.