Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angiocrine, Bioxcel, Gyroscope, Inventiva, Sebela, Sorrento, Surface.
According to an analysis conducted by BioWorld of the third-quarter 2020 financial reports filed by public biopharmaceutical companies with market caps greater than $1 billion, and excluding big pharma companies, the amount that was invested in research and development (R&D) during the nine-month period increased by almost 21% compared to the same period last year. The spending was bolstered by companies turning their attention to focus their research on therapies and vaccines to tackle COVID-19.
Now that the FDA has granted emergency use authorization to Eli Lilly and Co.’s bamlanivimab, the company plans to manufacture up to 1 million doses of the therapy by year-end with worldwide distribution to mild to moderate COVID-19 patients ages 12 and older in early 2021.
LONDON – Biontech SE is looking ahead from the announcement on Nov. 9 of 90% efficacy in the interim analysis of the phase III trial of its COVID-19 vaccine to outline shipping and distribution plans.
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.
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