As of Aug. 13, more than 90,000 patients hospitalized in the U.S. with COVID-19 already had been given access to convalescent plasma through a national expanded use protocol (EAP) sponsored by the Mayo Clinic. The FDA’s decision Sunday to grant emergency use authorization (EUA) for the potential therapy will further expand access to convalescent plasma for hospitalized patients throughout the country at a time when fully approved COVID-19 treatments are nonexistent and even EUAs are few and far between.
DUBLIN – Adrenomed AG has reported encouraging, albeit limited, data for its antibody adrecizumab in eight COVID-19 patients in Germany with life-threatening acute respiratory distress syndrome (ARDS). The drug was made available on a named-patient basis to critically ill patients undergoing mechanical ventilation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Capricor, EMD Serono, Gyroscope, Imara, Knight, Metacrine, Regenxbio, Sarepta, Therapeuticsmd.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainsway, Guardant Health, Helixbind.
Through the use of sequencing data, researchers in Hong Kong presented a case study providing the strongest evidence yet that individuals can become reinfected with SARS-CoV-2 after clearing a first infection.
HONG KONG – Last week was a busy one for Harbour Biomed Therapeutics Ltd., seeing the company sign a COVID-19 research collaboration with several Dutch institutions as well as lodge an application to list on the Hong Kong Stock Exchange.
RSS
