Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elekta, Genscript.

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioelectronics, Careprotocol, Decision Diagnostics, Djo, Genassist, Hancock Jaffe, Mesa Biotech, Orthoalign, Progenity, Scott Specialties, Verida.

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA tweaks export final guidance per CARES Act; OIG: CMS should act to recover payments for device credits.

Lenzilumab, the lead candidate from Humanigen Inc., has taken two large steps forward with positive interim phase III data and some support from the federal government. That, along with an Asia-Pacific region licensing from earlier in the week, has the relatively small company successfully “punching above our weight,” the CEO told BioWorld.

The Coalition for Epidemic Preparedness Innovations (CEPI) said that it would fund a SARS-CoV-2 vaccine under development by Sichuan Clover Biopharmaceuticals Inc., of Chengdu, China.

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE reviews Dexcom’s G6; Ortho claims EUA for antigen test with 100% sensitivity.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Astellas, Basilea, Gosun, Bristol Myers Squibb, Lipocine, Sarepta, Sedor, Senhwa.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affimed, Artiva, Astrazeneca, Felix Bio, ICER, Kannalife, OM Pharma, Roche, TFF, Vaccibody, Vir.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Assembly, Boehringer Ingelheim, Equillium, Homology, Humanigen, Janssen, Novartis, Pfizer, Puma, Seres, Viela.