Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Cytodyn, Daewoong, Five Prime, Flexion, Kadmon, Lundbeck, Millendo, Protagonist, Revance, Savara, Scholar Rock.

Just days after Foster City, Calif.-based Gilead Sciences Inc. gained emergency use authorization (EUA) from the FDA for antiviral Veklury (remdesivir) for the treatment of patients with SARS-CoV-2 infection, the virus that causes COVID-19, Japan invoked its own exceptional approval pathway to give the drug the green light to treat patients with severe COVID-19.

The U.S. National Institutes of Health recently announced a competitive grant opportunity for testing for the SARS-CoV-2 virus, which has been characterized as a “Shark Tank-like” program, and NIH director Francis Collins said in a May 7 Senate hearing that one of the criteria for awards is whether supplies can be made readily available for that test, the lack of which has been a significant impediment to testing in the U.S.

A brief glossary of the types of tests used and in development.

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: 3M, Aesculap, Daddybaby, Guangdong Nuoakang Medical Technology.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bittium, Camber Spine, Grifols, Neumodx, Sherlock Biosciences.