Although the death toll in the U.S. is nearing 1 million lives lost, signs continue to suggest that an end is in sight for the COVID-19 pandemic, the most disruptive global health crisis in a century.
Given the safety and efficacy data presented June 7 for Novavax Inc.’s COVID-19 vaccine, NVX-CoV2373, it came as no surprise when the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee voted 21-0, with one abstention, to support an emergency use authorization for the vaccine, which is already approved and being used in many other countries, including the EU and Canada.
Even as new waves of COVID-19 cause less direct disruption in the delivery of health care, the ongoing pandemic leaves a dramatically altered landscape for medical devices in its wake. The RBC Global Healthcare Conference revealed trends that will continue to reshape the utilization of medical technology and delivery of health care, while industry leaders drilled down into the details in a focused panel discussion. All agreed: the pandemic catapulted telemedicine and remote monitoring ahead five or more years, a hybrid delivery system with greater fluctuations in volume will emerge, devices that facilitate the movement of care out of the hospital to home or outpatient settings will remain in high demand and patient-centered control of health care will continue to attract additional industries into health care markets.
Although the death toll in the U.S. is nearing 1 million lives lost, signs continue to suggest that an end is in sight for the COVID-19 pandemic, the most disruptive global health crisis in a century. Now, into its third year, those at-risk have numerous options and growing numbers of people have achieved immunity through vaccines and infection.
Shares of Novavax Inc. dropped 19% after briefing documents released ahead of the U.S. FDA’s June 7 advisory committee raised concerns about risks of myocarditis associated with COVID-19 vaccine NVX-CoV2373, though reviewers also noted the vaccine could offer protection against the omicron variant. The stock (NASDAQ:NVAX) closed June 3 at $44.76, down $11.21.
Although the death toll in the U.S. is nearing 1 million lives lost, signs continue to suggest that an end is in sight for the COVID-19 pandemic, the most disruptive global health crisis in a century.
The U.S. Department of Justice and the Securities and Exchange Commission have separately indicted Marc Schessel and his company, Scworx Corp., for making false statements about the company’s ability to provide rapid tests for the COVID-19 pandemic. The indictments include allegations that Schessel and his company had been advised that the tests they had intended to procure were no longer available for distribution in the U.S., but that the Schessel did not advise shareholders of this fact for another 11 days.
About 56% of the clinical data recorded by BioWorld in 2022 target therapies for oncology, as well as infectious and neurological diseases, but news on COVID-19 efforts continue to dwindle compared with last year.
Lumiradx Ltd. has secured CE marking for its HbA1c test for diabetes. The point-of-care (POC), automated fingerstick assay is run on the Lumiradx portable platform and designed to provide connected results in under seven minutes, with a reportable range of 20-130 mmol/mol HbA1c (4.0% to 14.0% HbA1c).
A year after the World Health Organization's (WHO) Independent Panel for Pandemic Preparedness and Response called for reforms to make COVID-19 the last pandemic, the panel remains solidly frustrated in its lack of progress. The WHO’s director general, Tedros Adhanom Ghebreyesus, emphatically agreed on May 18, saying he was taken aback by data showing COVID-19 cases rose in four out of the six WHO regions just in the past week.
