In yet another setback for AstraZeneca, U.S. health officials raised concerns that the company included outdated information in its interim analysis of data from its U.S. phase 3 vaccine trial, prompting AZ to say it will release the results of its primary analysis by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

The Russian Direct Investment Fund (RDIF) and Indian contract manufacturer Stelis Biopharma have partnered to produce 200 million doses of the Sputnik V COVID-19 vaccine. Read More

HHS is postponing implementation of a final rule issued late in the Trump administration that would have required the FDA to review practically every regulation it has and redirect resources away from pandemic relief efforts. Read More

The FDA’s Office or Regulatory Programs has sent letters to 25 manufacturers, distributors and sellers telling them to stop producing and issuing these certificates. Read More