Jam-packed with efforts to address COVID-19 variants and next-step booster shots, as well as safety concerns over vaccine co-administrations and the expansion of emergency use authorizations (EUAs) into younger populations, May was another busy pandemic-fighting month for the world, despite higher numbers of those vaccinated and declining death and hospitalization rates.
Trading in shares in AB Science SA was suspended Tuesday after a safety signal prompted a voluntary hold on two late-stage clinical studies of its masitinib, in mastocytosis and amyotrophic lateral sclerosis, respectively.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guardant Health, Intelligent Implants, Thermo Fisher Scientific.
HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affamed, Amgen, Astrazeneca, Biohaven, BMS, Calliditas, Diurnal, Eton, Fennec, Humanigen, Iterum, Lantheus, Novo, PCI, Provention, Ryvu, Verrica.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beroni, Cyclerion, Disc, Hunterian, Roche, Sapience, Synbal, Tetra.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antengene, Chiasma, Cstone, Eqrx, Omeros, Tetra, Turning Point, Zai Lab.
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