After NDEA and NDMA, the FDA found another possible carcinogen in a common class of blood pressure drugs ending in -sartan, triggering losartan recalls by India's Hetero Labs and Torrent Pharma. Under China's recently released final rules for a Nasdaq-style board, qualified prerevenue biotechs could be listed in Shanghai. The Philippine Department of Justice plans to indict Sanofi and local government officials in connection with the country's Dengvaxia rollout. And more.
The FDA has found a third type of possible cancer-causing impurity in -sartan blood pressure drugs. India’s Hetero Labs said it would recall 87 lots of losartan tablets distributed by Camber Pharmaceuticals because they contain NMBA, a possible carcinogen. Torrent Pharmaceuticals also started recalling some of its losartan products because of the same impurity.
2. China unveils final rules for Nasdaq-style high-tech board
China’s securities authorities released final rules for the country’s new Nasdaq-style high-tech board, which could compete with Hong Kong and New York for listing of China-based tech companies, including biotechs. To be hosted at Shanghai Stock Exchange, the new board could allow prerevenue biotechs to be listed, provided they have valuations of no less than 4 billion Chinese yuan ($600 million) and at least one product cleared for phase 2 studies, according to the registration rule (Chinese, PDF).
The Philippine Department of Justice said they had found probable cause to indict Sanofi managers and government officials for their alleged “reckless imprudence resulting to homicide” in connection with a Dengvaxia vaccination campaign. The prosecutors said using the vaccine had led to the deaths of 10 children. Sanofi says it “strongly” disagrees with the findings and will “vigorously” defend its employees.
Ascletis nabbed MSD China's global VP Zhengqing Li, Ph.D., as its head of research and development. As general manager of MSD China’s R&D operations since 2011, Li helped with Chinese approval of more than 20 products, including Keytruda and hepatitis C treatment Zepatier. Ascletis’ hep C drug Ganovo recently became the first domestically made direct-acting antiviral approved in China.
Astellas teamed up with ReForm Biologics to help formulate its clinical-phase biologics. The project builds on ReForm’s viscosity-reducing excipients, which are designed to improve biologics formulation. For example, the excipients can facilitate delivery of large molecules via subcutaneous injections or as part of drug-device combinations.
Nichi-Iko Pharmaceutical’s U.S. unit Sagent Pharmaceuticals snapped up an FDA-approved small molecule and biologics manufacturing site in Raleigh, North Carolina, from Danish firm Xellia Pharmaceuticals. The facility is the first U.S. plant for Tokyo-based Nichi-Iko, as Sagent has traditionally relied on contractors to produce its sterile injectables.