Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affimed, Applied, Celularity, Fera, Nicox, Pfizer, Pharmamar, Seattle Genetics.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AC Immune, Adaptive, Advanz, Aicuris, Alnylam, Amgen, Ansun, Apeptico, Astrazeneca, Aurobindo, Axxam, Bharat, Bioaegis, Celator, Celularity, Cobra, Combigene, Cortexyme, Cytodyn, Elevation, Ennaid, ERS, Evotec, Flugen, Foamix, 14ner, Ipsen, Kite, La Jolla, Leo, Menlo, Merck, Merrimack, Novartis, Noxopharm, Paratek, Perrigo, Persephone, Ra, Redhill, Relief, Sandoz, Serimmune, Sonnet, Sorrento, Tetra, Teva, UCB, Vir, Zealand.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Apeiron, Arena, Atara, Athera, Axial, Biogen, Dermavant, Eiger, Fulcrum, Geron, I-Mab, Mateon, Merck, Moleculin, Momenta, Noxxon, Oncolytics, Rhovac, Valbiotis, VBL, Xbrane, Zymeworks.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3D Medicines, Alphamab, Altimmune, Amgen, Aptorum, Aravive, Astrazeneca, Bellerophon, Benitec, Cobra, Compass, Covar, Curetis, Diverse, Forty Seven, Genexine, Gigagen, Gilead, Harmony, Hoth, I-Mab, Imaginab, IMV, Isoprene, Lifemax, Moderna, Nanotx, Noveome, Numab, Olix, Ono, Opgen, Plus, Simcere, Surrozen.

PERTH, Australia –Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD).

The latest global regulatory news, changes and updates affecting biopharma.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Aveo, Concert, Cytodyn, Diurnal, Faron, Mallinckrodt, Mesoblast, Novoteris, Orchard, Y-mabs.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, Astellas, Azurrx, Cardiol, Citius, China Shijiazhuang Pharmaceutical, Daiichi Sankyo, Danaher, Daré, Diffusion, Editas, Eisai, Emergent Biosolutions, Eyepoint, Flexion, GE, Immunitybio, Innovation Pharmaceuticals, Macromoltek, Modalis, Novavax, Novellus, Ocumension, Oramed, Ostrich, Paratek, Regenxbio, Sanbio, Seikagaku, Soleo Health, Sorrento, Ultragenyx, Vaccibody.