Pink Sheet reporters and editors discuss the three-day US FDA advisory committee review of several oncology accelerated approvals, President Biden’s speech to Congress and its impact on drug pricing legislation, as well as the implications of the US helping India battle its COVID-19 surge.

Pink Sheet reporters and editors discuss the response to the rare blood clots seen with Janssen’s COVID-19 vaccine, the US FDA’s new virtual facility inspection guidance, and the new permanent director of the Center for Drug Evaluation and Research.

The EU and the UK are going their own way when it comes to making COVID-19 vaccines and treatments available. The European Commission has chosen the full conditional marketing authorization path, while the UK, no longer a member of the EU, is taking the temporary authorization route. 

Pink Sheet reporters and editors consider the impact of pre-announced domestic inspections, as well as look at the various COVID-19 vaccine safety monitoring programs and new data on application decisions during the pandemic.

Pink Sheet reporters and editors discuss the impact of the COVID-19 pandemic on pharma and the FDA and consider former commissioners’ pleas for President Biden to nominate a permanent agency commissioner.

We clean out your President’s Day inbox so you don’t have to.