Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Arch, Bridge, Cynata, Cytokinetics, Junshi, Pluristem, Redhill, Sesen, Takeda.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acadia, Arcturus, Beroni, Fortress, Oncogenuity, Sorrento, Zyus.

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.