PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.

As cyberattacks on U.S. hospitals continue to increase with health care’s growing reliance on technology, a new report from the U.S. Office of Inspector General (OIG) has flagged Medicare’s requirements for being silent on the cybersecurity of networked medical devices. The OIG’s study found hospitals are not required to identify networked device cybersecurity in their emergency preparedness risk assessments, and as a result, they don’t include this information “very often.”

The U.S. Senate and the House of Representatives have reintroduced the Verifying Leading-edge IVCT Development (VALID) Act, a bill that would authorize the FDA to regulate lab-developed tests (LDT). The question of the agency’s statutory authority to regulate LDTs is part of a long-running debate, but the immediate question is whether Congress will see fit to deal with the question this year rather than wait until 2022, when the next device user fee will require legislative authorization.

DUBLIN – In a busy week at the EMA, its Committee on Human Medicinal Products (CHMP) nodded through eight marketing applications at its June meeting. The haul included a chimeric antigen receptor T-cell (CAR T) therapy, three antibodies, including a biosimilar, and two new small-molecule drugs, as well as two generics.

A new regulatory agreement could give Indonesia greater access to newer drugs and Chinese companies greater market share in Southeast Asia’s largest market.

PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates.