HONG KONG, BEIJING and CAJICA, Colombia – Anvisa, Brazil’s health care surveillance agency, has halted the final-stage trials for Beijing, China-based Sinovac Biotech Ltd.’s COVID-19 vaccine candidate Coronavac after a serious adverse event occurred on Oct. 29 and was communicated to the regulator. Anvisa then evaluated the data and suspended the trials after weighing the risk-benefit of continuing them in the country, it said.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Betterlife, Clinigen, Emmaus, Forma, Immune-Onc, Lilly, Oryzon, Praxis, Rafael, Supernus.
LONDON – A new study has delivered evidence that people who survive COVID-19 infection are at increased risk of being diagnosed with a psychiatric disorder.
HONG KONG – Incheon, South Korea-based Celltrion Inc. has gleaned positive results in a small early stage trial for its anti-COVID-19 monoclonal antibody CT-P59. The results were presented at the Korean Society of Infectious Diseases’ 2020 fall conference, which took place on Nov. 5.
Enthusiasm stayed high but abated somewhat throughout the day as Wall Street took in the positive interim phase III results from Biontech SE and Pfizer Inc. with the COVID-19 vaccine candidate BNT-162b2.
Preparing for a Biden presidency in which COVID-19 will be a top priority, the Joe Biden-Kamala Harris transition team named a board of scientists and public health experts Nov. 9 to advise the team on how to respond to the surging pandemic in the U.S.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amo, Astrazeneca, Axovant, Bayer, Beigene, Eusa, Impel, Liminal, Novavax, Orphazyme, Sorrento.