Pink Sheet reporters and editors discuss the US FDA decision to lower the eligibility age for the Pfizer/BioNTech COVID-19 vaccine, CMS drug pricing project plans, and mid-stream standard of care changes in drug development.

Rolling reviews are now in progress at the European Medicines Agency for four COVID-19 vaccines and for four potential COVID-19 treatments.

Pink Sheet reporters and editors discuss the potential for the US and other governments to waive IP protections for COVID-19 vaccines, the FDA’s inspection backlog during the pandemic, and potential reimbursement changes for CAR-T therapies.

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.