Chinese authorities this year for the first time allowed access for complete U.S. Public Company Accounting Oversight Board (PCAOB) audit inspections and investigations of PCAOB-registered public accounting firms headquartered in China and Hong Kong, in accordance with U.S. securities law.

One of the big regulatory and pandemic stories of 2022 with global impact was the June 17 World Trade Organization’s (WTO) agreement on a five-year intellectual property (IP) waiver for COVID-19 vaccines and their components.

Responding to concerns about corporate insider trading, especially among life sciences companies, the U.S. SEC unanimously adopted final rules Dec. 14 establishing a 90-day cooling-off period before trades can be made under 10b5-1 plans that provide a safe harbor to insider trading.

The U.S. FDA’s use of remote regulatory assessments (RRAs) during the pandemic may have been inevitable, but a proposed continuation of the program in the endemic phase of the SARS-CoV-2 contagion hasn’t necessarily won over device manufacturers.

Biocorp Production SA has been awarded 510(k) clearance from the U.S. FDA to market Mallya as a medical device that connects insulin pens. The news, out on Dec. 8, led Biocorp’s stock price to jump 32.69% to $21.52.

Dexcom Inc. ends 2022 on a high note with broad clearance from the U.S. FDA for its G7 continuous glucose monitoring system (CGM). The long-awaited 510(k) clearance encompasses use in people with all types of diabetes age two and older, positioning Dexcom to take advantage of expanded coverage of CGMs to include individuals on basal insulin-only for Medicare beneficiaries as proposed by CMS in October.

Shanghai Microport Endovascular Medtech Co. Ltd.’s Hercules balloon dilation catheter has been approved for marketing approval in China to be used in endovascular aneurysm repair (EVAR) procedures.

Apoqlar GmbH received a green light from the FDA for its VSI Holomedicine, a mixed reality software enabling surgeons to plan procedures in an immersive 3D experience. The company expects to release the technology for clinical use in the U.S. in the second quarter of 2023.