Sato Kogyo Co. Ltd., of Kashihara City, Japan, received an FDA warning letter citing concerns about data integrity. The letter stems from a June inspection in which an FDA investigator noted audit trails indicating duplicate testing for impurities, within a 24-hour period, in the plant's high performance liquid chromatography system. There was no justification given for the repeat testing, and data from the first analysis were not maintained. To resolve the concerns, the FDA instructed the company to conduct a comprehensive investigation into the extent of the inaccuracies in its data records and reporting and to complete a current risk assessment of the potential effects of the data failures on the quality of the company's drugs. Read More

NEW DELHI –In the wake of the death of a U.S. woman who had been infected with a drug-resistant bug in India, the country's drug regulator has ordered all companies involved in the drug supply chain system to strictly follow the country's guidelines in the Drugs and Cosmetics Act on the sale of medicines. Read More

A study by researchers in Singapore has identified optogenetic inhibitors of brain activity and successfully demonstrated their efficacy in a Drosophila melanogaster fruit fly model, which should improve our understanding of the relationship between neural circuits and behavior. Read More

On the basis of two successful phase III studies in China, Fibrogen Inc. looks headed toward a new drug application submission in the country this year for roxadustat (FG-4592), its oral small molecule to treat anemia in non-dialysis-dependent chronic kidney disease (NDD-CKD) and dialysis-dependent CKD (DD-CKD) patients. Read More

SHANGHAI – Beigene Co. Ltd., of Beijing, is advancing its small-molecule Bruton's tyrosine kinase (BTK) inhibitor candidate, BGB-3111, in a global phase III trial for patients with Waldenström's macroglobulinemia (WM, or lymphoplasmacytic lymphoma), a type of non-Hodgkin lymphoma. Read More

HONG KONG – China has launched a two-invoice system for drug procurement as part of a change that underscores an ongoing reshuffle of the health care industry in the country. By limiting the number of invoices allowed in the drug distribution chain, the system aims to eliminate middlemen, avoid unnecessary invoicing that may facilitate corruption and increase transparency in drug pricing. Read More