U.S. federal authorities have made a lot of noise over inappropriate medical testing in the past two years, largely due to the COVID-19 pandemic, but Paul Garcia, a partner in the San Diego office of Hooper, Lundy & Bookman PC, says this trend will not ebb at all in the coming year. Garcia told BioWorld that the lookback period for Medicare testing claims runs several years and that not only will enforcement results continue to surface next year, but also that the associated civil monetary penalties could force a testing lab to shutter its operations permanently.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bittium, Quantumdx.
Vaxxas Pty. Ltd. raised AU$34 million (US$23 million) to advance its needle-free COVID-19 vaccine program, which began in early November, and readouts from the study are expected in late February or early March, Vaxxas CEO David Hoey told BioWorld. The COVID-19 vaccine patch is based on the company’s high-density microarray patch technology that delivers Hexapro, a second-generation version of the spike protein used in all major U.S.-approved COVID-19 vaccines.
COVID-19 has vexed researchers, physicians and public health authorities since its emergence with an unexpectedly rapid rate of mutation. In addition to requiring constant adjustment of therapeutics and repeated vaccinations, the ever-changing virus has rapidly made scores of prognostic models irrelevant within months of development. Feinstein researchers appear to have met the challenge with an auto-updating model that predicts 28-day survival in patients hospitalized with COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogx, Novocure, Trireme Medical.
While weekly global and U.S. confirmed cases of COVID-19 are below each of the last two years, infectious disease experts remain on guard. There are still about 1,500 people dying around the world each day, including 350 in the U.S., and the SARS-CoV-2 virus may continue to find ways to outmaneuver current treatments and vaccines.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Novacyt, Radiaction, Transit Scientific.
Molecular Sensoring Technology Co. Ltd. (Molsentech) has developed a diagnostic platform using semiconductor chips with biosensors for COVID-19 testing. The platform could deliver a result anywhere from three to 30 minutes, with accuracy compatible to the polymerase chain reaction (PCR) tests.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aptitude Medical, Depuy Synthes, Sol-Millennium.
The White House laid out several timelines Oct. 18 as part of a national biodefense strategy for countering biological threats and enhancing global pandemic preparedness.