The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has converted its regulatory sandbox for artificial intelligence (AI) into a full-fledged program dubbed the AI-Airlock, described as a regulatory-monitored virtual area in which industry can “generate robust evidence for their advanced technologies.” MHRA said it is focused on ensuring that AI products are available in the U.K. “before they are available anywhere else in the world,” a sign that national economic competitiveness is fostering a regulatory willingness to deal with uncertainty about this class of products.

Immuone Ltd. raised £2 million (US$2.4 million) to fund expansion of its operations to meet growing demand for its 3D human lung model. The company is hoping that its model will replace animal testing which is not always accurate at predicting the impact of drugs on humans. The funding came from the MEIF Proof of Concept & Early Stage Fund, Mercia’s EIS funds and Pioneer Group.

Shanghai-based Henlius Biotech Inc. and India’s Intas Pharmaceuticals Ltd. agreed upon a potential €185 million (US$195.38 million) licensing deal for Intas to develop and sell Henlius’ China NMPA-approved lung cancer drug, serplulimab, across Europe and India. Serplulimab (HLX-02) is a recombinant humanized PD-1 monoclonal antibody (MAb) injection that first gained approval as Hansizhuang in March 2022.

The U.K. government has launched a £100 million (US$122 million) fund that will accelerate the development of artificial intelligence (AI) tools to help tackle some of the biggest challenges in health care.

Virtually all regulatory systems present at least some ambiguity as to the respective regulatory status of software when installed in hardware for medical purposes, and the European Commission’s (EC’s) Medical Device Coordination Group (MDCG) has attempted to provide clarity on these questions.