Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akouos, Belief, Dermavant, Fibrogen, GW, Innocare, Lantern, Merck, Phasebio, Reata, Roivant, SFJ.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptive, Advaxis, Algernon, Alphabet, Bio-Thera, Clene, Curebase, Dyadic, Hoth, Humacyte, Imbrium, Kaleido, Lumen, Merz, Mindset, Moderna, Neximmune, Nouscom, Orizuru, Protagonist, Purdue, Puretech, Q Biomed, Sab, Second Genome, Skye, Sorrento, Therapeutic Solutions, Tryp, Vensica, Veraxa, Wesana, Zealand.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apollomics, Athersys, Avacta, Azurrx, Cohbar, Crinetics, Cytoagents, Flexion, Fulcrum, Goldfinch, Grunenthal, Healios, Heparegenix, I-Mab, Immvira, IMV, In8bio, Inflarx, Novaliq, Nrx, Point, Pulmatrix, Reata, Retrotope, Rezolute, Sinovac, Summit, Trevena.

SK Bioscience Ltd. has won approval from the South Korean Ministry of Food and Drug Safety (MFDS) to begin a phase III trial for its COVID-19 vaccine candidate GBP-510, making the recombinant protein antigen vaccine the first domestically developed candidate to make it to late-stage testing. “We aim to begin the phase III trials within August and to have the data ready by early 2022,” a company spokesman told BioWorld.

Rick Bright, who filed a whistleblower complaint last year against the U.S. Department of Health and Human Services (HHS) after he was removed from his position as director of the Biomedical Advanced Research and Development Authority (BARDA), reached an undisclosed settlement with HHS, the U.S. Office of Special Counsel reported Aug. 9.

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

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Asia Molecular Diagnostic Laboratory, Cardinal Health, China Biotech Services Holding, Empiramed, Fitbit, Fujifilm, Fujifilm Irvine Scientific, Happify Health, Life Whisperer, Lifescan, Oncxerna Therapeutics, Pillar Biosciences, Presagen, Pyramid Innovation, Qiagen, Quidel, Statlab Medical Products.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Advaccine, Ascletis, Astrazeneca, Autolus, Bluebird, Biohaven, Calliditas, Dare, Eton, Inovio, Moderna, Relief, Sanofi, Yisheng.