Nearly a year after the SARS-CoV-2 virus first appeared in Wuhan, China, a ray of hope is shining on the world with high efficacy reported for four vaccines and U.S. emergency use authorizations granted to three more therapeutics.

The latest global regulatory news, changes and updates affecting biopharma, including: DEA gets on board with partial Rx fills; USPTO touts early results of amendment pilot; FDA posts combo product feedback final guidance.

Moderna Inc., late on Nov. 30, said it has asked the FDA to bless emergency use of its COVID-19 vaccine mRNA-1273 after phase III data confirmed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. The Cambridge, Mass.-based company said efficacy was "consistent across age, race and ethnicity and gender demographics."

Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.

HONG KONG – Peptidream Inc. has partnered with four other Japanese companies to research and develop peptide therapeutics capable of neutralizing the SARS-CoV-2 virus as well as potential future coronavirus outbreaks. Peptiaid Inc., the joint venture established with Fujitsu Ltd., Mizuho Financial Group Inc. subsidiary Mizuho Capital Co. Ltd., Takenaka Corp. and Kishida Chemical Co. Ltd., will have capital totaling ¥599 million (US$5.73 million) by Dec. 31.

LONDON – Results from the phase I/II trial of Coronavac, a COVID-19 vaccine based on a traditional inactivated whole SARS-CoV-2 virus that circulated in China in the early days of the pandemic, show it is safe and induces an antibody response in healthy volunteers ages 18 to 59.

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.

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.