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.
Astrazeneca plc has reached an agreement with Shenzhen-based Kangtai Biological Products Co. Ltd. to produce its COVID-19 vaccine AZD-1222 in China. The Chinese firm is required to produce at least 100 million doses by the end of the year, and at least 200 million doses by the end of 2021.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Helix, Nanotronics Health.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Appili, Aquestive, Chi-Med, Diurnal, Gilead, Mallinckrodt, Ocugen, Pluristem, Reata, Seelos, Trevena, Vaxart.
RSS
