Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Neuroplast, Revance, Silence, Vanda, Veru, Yishengbio.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzinova, Amgen, Ashvattha, Aslan, Bicycle, Biogen, Bioinvent, Biophytis, Biovie, Curasen, Edesa, Eli Lilly, Erasca, Flugen, Genfleet, Glaukos, Inflarx, Inxmed, Ionis, Isofol, Lianbio, Lutris, Lyra, Mind, Muvon, Nektar, Ocuphire, Oncxerna, Palatin, Regeneron, Salubris, Scynexis, Spine, Synairgen, Teva, UCB, Vaxcyte, Vistagen, Zynerba.

Inflarx NV is poised to apply for U.S. FDA emergency use authorization for its complement inhibitor, vilobelimab, in treating seriously ill, mechanically ventilated COVID-19 patients, following a reappraisal of the statistical analysis of the 369-patient placebo-controlled phase III trial.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Basilea, Nodus, Takeda, Tetra, Tikomed, Virogin, Zealand.

Akston Biosciences Corp. emerged from a successful small company that was sold to a pharma major. For Todd Zion, that’s a back-to-basics move that suits him just fine. Zion co-founded Smartcells Inc. in 2003 with technology developed at the Massachusetts Institute of Technology. The company went on to develop the once-daily injectable self-regulating insulin product, Smartinsulin, and sold it to Merck & Co. in what was at the time one of the largest preclinical pharmaceutical acquisitions ever.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Amylyx, Aston, Astrazeneca, Bausch + Lomb, Novaliq, Novavax, Tenaya.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, Alaunos, Bavarian Nordic, Boehringer Ingelheim, Clarity, Dizal, Dyne, Immutep, Innovent, Ironwood, Iveric, Jacobio, Laekna, Mannkind, Regeneron, Sanofi, Yingli, Zymeworks.

Biovaxys Technology Corp. has announced that Millipore-Sigma, the contract manufacturer for its preclinical viral vaccine program, has completed the bioproduction and batch release endotoxin screening of BVX-1021, the company's vaccine for SARS-CoV, which is being used in the collaboration with The Ohio State University (OSU) to develop a pan-sarbecovirus vaccine.