Bamlanivimab: Monoclonal Antibody Treatment Presents Special Difficulties in Administration:
The medical and research establishments certainly have given their best during this pandemic. Eli Lilly is no exception, having marshalled thousands of scientists, research professionals, and clinical trial teams to develop and test novel drugs with the aim of treating a new and deadly virus. Recently, one of the company’s breakthrough investigational monoclonal antibody therapies, first known as LY-CoV555 and now “Bamlanivimab,” was made available as a COVID-19 treatment under an Emergency Use Authorization (EUA), per the NEJM’s Journal Watch Blog. The only acceptable use at this time involves outpatients currently deemed a high risk for severe disease progression and/or hospitalization. Much like remdesivir, the first approved therapy—controversially many may add—this emergency use treatment fails the ease-of-administration test. In the case of Bamlanivimab, it’s not only difficult to pronounce the investigational product’s name, but also even more challenging to actually administer it to patients. The federal government has paid Lilly $3.75 billion for investigational product costs (deal done at $12,500 per treatment, for 300,000 in initial shipment) on the taxpayers’ “dime.”
U.S. Senate Committee to Hold Hearing on COVID-19 Home Treatment Status:
An important medical research blog called COVEXIT recently reported that the concept of outpatient home care for COVID-19 now progresses in America with a forthcoming hearing scheduled for Thursday, Nov. 19 at 10:00 a.m. Sponsored by the Committee on Home Security & Governmental Affairs, the hearing is led by Senator Ron Johnson (WI) as chair and Senator Gary Peters (MI) as ranking member. This committee includes Kamala Harris, Mitt Romney and Rand Paul. A link to the forthcoming hearings is available here.
Sinovac’s CoronaVac trial reauthorized by Anvisa: Phase 3 Clinical Trial Continues on:
TrialSite News recently reported that the Brazilian drug regulatory authority has halted the Sinovac (CoronaVac) COVID-19 vaccine trial, however days later Brazil’s National Health Surveillance Agency (Anvisa) authorized the resumption of the Phase 3 clinical trial testing the inactivated COVID-19 vaccine known as CoronaVac®. The Brazilian study is sponsored by Butantan Institute.