An update from China’s NMPA clarifying registration requirements and classification methods for drug-device combination products has been welcomed by industry as the regulator seeks to keep pace with fast-moving developments in the sector.

PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options.

The Biden administration’s rollout of a COVID-19 booster plan before the FDA has even approved a booster admittedly is a “judgment call,” U.S. health officials acknowledged Aug. 18. But rather than a judgment call, “the introduction of booster doses should be evidence-driven and targeted to the population groups in greatest need,” the World Health Organization advised in an interim statement issued a week before the White House COVID-19 Response Team’s announcement.

The FDA’s emergency use authorization (EUA) program is still active in the area of tests and test kits, which is due in part by the emergence of the Delta variant of the SARS-CoV-2 virus and the associated warnings that the effectiveness of vaccines may be declining. One example of the sustained emphasis on testing is the EUA granted to Thermo Fisher Scientific Inc. for two PCR test kits that can detect the latest variants of the virus, a demonstration that the demand for these updated tests seems unlikely to ebb anytime soon.

Abiomed Inc. is one of a number of companies whose share prices took a hit in the early days of the COVID-19 pandemic, but the company has since rebounded, thanks in part to the news that the FDA has granted the company a breakthrough device designation for its Impella ECP device. The external counterpulsation (ECP) system may eventually make significant headway in the hemodynamic support space thanks to the small size of the device, a key feature for patients undergoing high-risk percutaneous coronary intervention (PCI) procedures.

Plans for offering COVID-19 vaccine booster shots in the U.S. took a big step forward Aug. 18, as Health and Human Services (HHS) public health and medical experts laid out their intention to offer booster shots across the country for people 18 and older beginning the week of Sept. 20 and starting eight months after an individual's second dose.

Voot Yin, co-founder and chief scientific officer of the Bar Harbor, Maine-based Novo Biosciences Inc., reached a settlement with U.S. Health and Human Services’ Office of Research Integrity over allegations that he faked data while conducting government-funded research at the Mount Desert Island Biological Laboratory in Maine.