President Biden made headlines this week by voicing strong support for waiving COVID-19 vaccine intellectual property (IP) rights during the pandemic, but any deal hashed out at the World Trade Organization (WTO) could come too late to make a significant impact. Read More

The FDA said yesterday that it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September. Read More

President Biden will support a World Trade Organization (WTO) proposal to waive patent protections for COVID-19 vaccines during the pandemic, marking a seismic shift in U.S. policy on intellectual property protections. Read More

Pfizer said yesterday that it plans to file for full approval of its COVID-19 vaccine by the FDA later this month — an approval that would allow the companies to market the vaccine directly to consumers and allow the product to stay on the market beyond the pandemic. Read More

The World Health Organization (WHO) has given Moderna’s two-dose COVID vaccine an Emergency Use Listing (EUL), making it eligible for use in the global COVAX initiative aimed at getting vaccines to low- and middle-income countries. Read More

The chief executive officer of troubled Emergent BioSolutions has promised to deliver “within days” the company’s response to a scathing Form 483 issued in April following a serious mix-up of vaccine materials that ruined millions of doses of Johnson & Johnson’s (J&J) COVID-19 vaccine. Read More

AstraZeneca (AZ) reportedly may not file for FDA Emergency Use Authorization (EUA) of its COVID-19 vaccine until mid-May as it needs more time to gather supporting data. Read More

The European Medicines Agency (EMA) is reviewing Eli Lilly’s arthritis drug Olumiant (baricitinib) as a possible treatment for hospitalized COVID-19 patients age 10 years and older who require supplemental oxygen. Read More

Moderna said it plans to produce up to 3 billion doses of its messenger RNA-based COVID-19 vaccine globally in 2022, including booster shots against viral variants and pediatric vaccines. Read More