PERTH, Australia – Australian regenerative medicine company Mesoblast Ltd. saw its stock tumble more than 30% following the release of briefing documents from the FDA ahead of an Aug. 13 advisory committee meeting to review the company’s BLA for Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease (SR-aGVHD) in children.

“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines.

PERTH, Australia – As the state of Victoria in Australia records its deadliest day since the COVID-19 pandemic began, reporting 17 deaths and 394 new cases, Atomo Diagnostics Ltd.’s new COVID-19 antibody test could ease pressure on health care systems.

The annual publication of the draft Medicare physician fee schedule (MPFS) is an event, but this year’s draft has drawn substantial criticism from across the board, despite the promise of more coverage of telehealth. The Medical Imaging & Technology Association (MITA) and a coalition of surgeons have blasted the draft as a hazard to patient access to both evaluation and management (E/M) services and surgical procedures, both of which present substantial headwinds for the medical device industry.

The U.S. FDA revealed good news for Guardant Health Inc. Specifically, the agency has given a thumbs up for Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm. The Redwood City, Calif.-based company noted that this marked the first approval to combine next-generation sequencing (NGS) and liquid biopsy in one diagnostic test to guide treatment decisions. The assay previously was granted a breakthrough device designation.

Knocked back by a complete response letter (CRL) in late 2018, Trevena Inc. dusted itself off, resubmitted its NDA for oliceridine and found satisfaction as the FDA has approved the opioid agonist.