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.
Sight Diagnostics Ltd. raised $71 million in series D financing to expand its commercial operations and increase research and development efforts into disease detection from its fingerprick blood analyzer Sight OLO.
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.
Shares of Omeros Corp. (NASDAQ:OMER) jumped 50.9% to $21.32 on Aug. 10 after it reported that six critically ill COVID-19 patients treated with its investigational lectin-pathway inhibitor, narsoplimab, recovered from the disease. The company said it will now seek government support to accelerate the drug’s large-scale manufacture. "We look forward to being able to make narsoplimab broadly available to hospitalized COVID-19 patients," said Omeros CEO Greg Demopulos.
“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.