The U.S. FDA has granted emergency use authorization (EUA) to New Haven, Conn., startup Vent Multiplexor LLC for its emergency rescue co-ventilation device. Developed in collaboration with Yale New Haven Hospital, the Vent Multiplexor enables individualized mechanical ventilation of two adults on a single ventilator – lessening demand for more critical care machines in the ongoing COVID-19 outbreak.
The COVID-19 pandemic has moved rapidly over the past few weeks, and Ortho Clinical Diagnostics Inc. is doing its part to help during the crisis. To that end, the Raritan, N.J.-based company has worked to successfully secure an emergency use authorization (EUA) for its total antibody assay for COVID-19, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 total reagent pack and calibrators.
HONG KONG – South Korea’s Osang Healthcare Co. Ltd. became the first Korean company to receive the U.S. FDA’s emergency use authorization (EUA) for its COVID-19 test kit. In a letter dated April 18, 2020, the FDA informed Osang of its authorization for the company’s Genefinder COVID-19 Plus Realamp Kit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytosorbents, Endospan, Fosun Pharma, Foundation Medicine, Genosensor, Osang Healthcare.
Although the COVID-19 pandemic has decimated the economy and played havoc with the financial markets, there are promising signs that investors are slowly returning as infection curves begin to flatten thanks to social distancing measures. There is no doubt that they are showing confidence in those leading biopharmaceutical companies who they believe hold the keys to unlocking cures for the deadly infection. In addition, amid the intense activity related to COVID-19 research and development, the FDA did take some time to approve several new medicines, reinforcing the fact that innovation has not been completely throttled by the industry’s focus on the pandemic.
Both ballyhooed and questioned as a potential savior from COVID-19, hydroxychloroquine is about to get a high-profile test by Basel, Switzerland-based Novartis AG. The company has reached an agreement with the FDA to run a phase III trial evaluating the drug for the treatment of hospitalized patients with COVID-19, with enrollment of 400 patients beginning within weeks and results to be reported as soon as possible.
Looking ahead to COVID-19 strategies, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said vaccine studies might be done not in clinics but in the streets. “By definition, we’re probably not going to be able to vaccinate everyone simultaneously,” he noted.