Russian researchers are reportedly seeking approval for a single-dose version of the Sputnik V COVID-19 vaccine and are conducting clinical trials in Russia, the United Arab Emirates and Ghana. Read More

The COVAX vaccine-sharing program will stockpile 5 percent of its vaccine doses for high-risk populations in humanitarian settings or for emergency outbreaks, said Gavi, the Vaccine Alliance, which operates the global program alongside the World Health Organization and the Coalition for Epidemic Preparedness Innovations. Read More

Regeneron Pharmaceuticals’ and Roche’s antibody cocktail, REGEN-COV (casirivimab/imdevimab), reduced the risk of hospitalization or death by 70 percent in high-risk nonhospitalized COVID-19 patients in a late-stage trial, the companies have said. Read More

Pfizer is conducting a U.S. phase 1 trial of an oral COVID-19 antiviral, PF-07321332, a protease inhibitor that can stop the virus from replicating. An oral drug would be much easier to administer than an intravenous formulation — a significant advantage during the pandemic. Read More

The Center for Drug Evaluation and Research (CDER) highlights efforts to deal with drug shortages, sham COVID-19 products and poorly compounded drugs, as well as its enforcement successes amidst the pandemic, in its latest annual report from its Office of Compliance, released yesterday. Read More

In yet another setback for AstraZeneca, U.S. health officials raised concerns that the company included outdated information in its interim analysis of data from its U.S. phase 3 vaccine trial, prompting AZ to say it will release the results of its primary analysis by Thursday. Read More

Oramed Pharmaceuticals has partnered with Premas Biotech to launch a joint venture, Oravax Medical, meant to develop the world’s first COVID-19 oral vaccine. Read More

The European Medicines Agency (EMA) has advised against the use of Merck’s anti-parasitic drug Stromectol (ivermectin) for the prevention and treatment of COVID-19. Read More

As the EU’s COVID-19 vaccine supply woes intensify, the 27-member bloc is signaling it could make good on its threat to halt exports of vaccine doses to the UK as soon as this week. Read More

AstraZeneca’s (AZ) COVID-19 vaccine clocked in at 79 percent efficacy in preventing symptomatic infection and fully shielded against severe disease and hospitalization in the company’s phase 3 U.S. trial, opening the door for an Emergency Use Authorization (EUA) filing with the FDA in a matter of weeks. Read More