Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Gene Technologies, Arvelle, Atyr, Clearside, Equillium, Fennec, Kyorin, Mersana, Mesoblast, Neurogene, Protalix.
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.
Nearly three years after an FDA rejection of Eagle Pharmaceuticals Inc.'s initial effort to add exertional heat stroke (EHS) to the list of approved indications for Ryanodex (dantrolene sodium), its efforts have again been met with a complete response letter. The calcium channel modulator is already approved for the treatment of malignant hyperthermia (MH), but Eagle said it has decided to drop further pursuit of EHS.
“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.