As a first step in developing a portfolio of COVID-19 therapies, the European Commission identified five promising candidates June 29, including four monoclonal antibodies under rolling review at the EMA and an immunosuppressant that could have its marketing authorization extended to include the treatment of COVID-19 infections.

The U.S. government on June 17 announced plans for a multi-faceted $3.2 billion investment in the development and manufacture of new antivirals for preventing serious COVID-19 illness and death.

In a bid to bring more drug manufacturing back to the U.S. and to ensure an adequate supply of essential medicines, even in public health emergencies, the U.S. Department of Health and Human Services is forming a public-private consortium on advanced manufacturing and the onshoring of domestic production.

The American Clinical Laboratory (ACLA) filed an appeal to revive its lawsuit against the U.S. Health and Human Services challenging HHS’ overhaul of the medical clinical lab fee schedule over its “harmful regulatory overreach” that imposes an “unsustainable reimbursement model.”

The Biden administration is reviving the U.S. FDA’s Unapproved Drugs Initiative, which was terminated late last year by the Trump administration.

The U.S. Health Resources and Services Administration (HRSA) ordered six drug companies May 17 to immediately resume providing 340B discounts to contract pharmacies without restrictions and to credit or refund overcharges stemming from those restrictions.

The Biden administration’s fiscal 2022 budget proposal included an allocation for an office described as the Advanced Research Projects Agency – Health, or ARPA-H, which would receive $6.5 billion as part of the National Institutes of Health.