From the beginning of the monkeypox outbreak in the U.S. in May, the federal government has bungled the response, according to both Democratic and Republican members of the Senate Health, Education, Labor and Pensions (HELP) Committee.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akouos, Atyr, Biontech, Clovis, Cstone, H. Lundbeck, Hansa, I-Mab, Innocare, Merck, Novavax, Otsuka, Pfizer, TC.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apollomics, Arctic, Biomarin, Biphytis, Caladrius, Cend, Coave, CSL, Eton, Foundation, Medincell, Metis, Nacuity, Obseva, Radiopharm, Relay, Respira, Sabin, Sunstone, Valeo.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adamis, Akero, Amolyt, Bioatla, Eli Lilly, Lyra, Nanoscope, On Target, Oramed, Rayzebio, Recursion Selection Sonalasense, Vaxxinity.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Biolinerx, BMS, Chiesi, Mersana, Vaxxinity.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adagio, Adial, Alume, Aptose, Attralus, Azura, Bavarian Nordic, Celgren, Cellusion, Epivax, Fosun, Infexious, Intravacc, Invivyd, Purnovate.

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.