The artificial intelligence (AI) space doesn’t exactly lack for stakeholders, but the roster of stakeholders in the U.S. is poised to grow by hundreds of millions, according to Laura Adams, senior advisor at the U.S. National Academy of Medicine.

Bayer AG said it will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market after a confirmatory trial required by the FDA failed to meet the primary endpoint of progression-free survival vs. standard immunochemotherapy in patients with relapsed follicular lymphoma. It marks the latest stumble for PI3K-targeting drugs in the non-Hodgkin’s lymphoma space.

The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review process has drawn fire from inventors as a patent-killing machine.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocardia, Brixton, Lunit, Mednition, Vyspine.

In the following years, 2023 may come to be seen in medical device circles as the year of artificial intelligence (AI), but that doesn’t mean that 2023 will be seen as the year of regulatory clarity for AI.

Inflammasome Therapeutics Inc. has received FDA clearance to begin a phase I/II trial of the company’s inflammasome inhibitor for the treatment of geographic atrophy, the most severe form of dry age-related macular degeneration. This is the first clinical trial of an inflammasome inhibitor to treat geographic atrophy. The company’s sustained-release implant contains the first of a new class of inflammasome inhibitor drugs, Kamuvudines, developed by the company and designed to halt the multiple processes that cause geographic atrophy.