EMA initiates OPEN collaboration

The EMA reported Feb. 4 on its OPEN initiative pilot to increase international collaboration on the evaluation of COVID-19 vaccines and therapeutics.

Regulators from Australia, Canada, Japan, Switzerland and the World Health Organization are participating in the pilot under the terms of existing confidentiality arrangements, the EMA said.

The collaboration allows the regulators to share scientific expertise when evaluating COVID-19 vaccines and therapeutics, promoting transparency and building public trust in the products. The pilot is expected to foster better understanding of regulatory outcomes, while retaining the scientific and regulatory independence of the participating agencies, according to the EMA.

NICE evaluating guidance processes

The U.K.’s National Institute for Health and Care Excellence (NICE) Feb. 4 launched the third in a series of public consultations on proposed changes to the processes it uses to develop guidance on drugs, medical devices, diagnostics and digital health technologies.

The proposals outline how NICE aims to focus its health technology evaluations “on not just final guidance as the main ‘output,’ but on moving towards ‘health technology management,’ where support for early development, early advice, adoption, real-world performance and reassessment are targeted to ensuring that the needs of patients and the NHS are front and center in our activities,” said Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Assessment at NICE.

One of the goals is to ensure that the U.K. remains a first-launch country for promising new health technologies.

The consultation will be open until April 15.

Florida researcher indicted

Lin Yang, a former University of Florida professor and researcher who is now living in China, was indicted on six counts of wire fraud and four counts of making false statements to a U.S. agency.

According to the December grand jury indictment that was unsealed Feb. 3, Yang received a $1.75 million NIH grant to develop and disseminate Muscleminer, an imaging informatics tool for muscles, and served as the principal investigator for the grant at the university from 2014 to 2019.

During that time, he established a business in China and promoted it by saying the products were the result of years of research supported by the U.S. government, according to the U.S. Department of Justice (DoJ). He also was accepted into China’s Thousand Talents Program, a government program that encourages the transfer of ideas, technology and intellectual property from foreign universities.

The indictment alleged that Yang, on multiple occasions, submitted financial disclosures to the NIH that contained false statements and omitted his conflicts of interest and other support related to his business in China, participation in the talent plan and affiliation with a Chinese research university. He also falsely stated in a 2019 University of Florida disclosure that he had no affiliation with any business, entity or university in China.

The maximum sentence for each count of wire fraud is 20 years in prison and a $250,000 fine. Each count of making false statements to a U.S. agency carries a maximum penalty of five years in prison, as well as a $250,000 fine, DoJ said.