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BioWorld - Wednesday, July 15, 2026
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Regulatory actions for May 28, 2021

May 28, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guardant Health, Intelligent Implants, Thermo Fisher Scientific.
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Flag of India

India does away with bridging trials for global vaccine candidates

May 28, 2021
By David Ho
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.
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Regulatory actions for May 28, 2021

May 28, 2021
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.
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Other news to note for May 28, 2021

May 28, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beroni, Cyclerion, Disc, Hunterian, Roche, Sapience, Synbal, Tetra.
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In the clinic for May 28, 2021

May 28, 2021
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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Regulatory actions for May 27, 2021

May 28, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioinvent, Dicerna, Eli Lilly, Emmaus, Foresee, Gannex, GSK, Hightide, Intercept, J&J, Legend, Myovant, Ocugen, Pfizer, Seelos, Tarus, Transgene, Vir.
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In the clinic for May 26, 2021

May 28, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ADC, Aim, Ammax, Aptevo, Biodesix, Biofactura, Ceapro, Connect, Elixirgen, Emergent, Exelixis, Eyepoint, Gensight, Glycomimetics, Jasper, Kintara, Maat, Medivir, Mindmed, Ose, Prosit, Tiziana, Zucara.
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Australia and coronavirus

Ausmedtech 2021: Lessons learned from COVID-19

May 27, 2021
By Tamra Sami
PERTH, Australia – With half the world’s population, Asia Pacific is quickly replacing Europe as the world’s second-largest medical device market, and China, Korea and Australia stand out as leaders, said Tim Schmid, company group chairman for Johnson & Johnson Medical Devices, Asia Pacific, during the recent Ausmedtech 2021 virtual conference.
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Regulatory actions for May 27, 2021

May 27, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Advanced Human Imaging, Avicenna.AI, Lantheus, Micro Interventional Devices, Nowdiagnostics.
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Other news to note for May 27, 2021

May 27, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: AIM Immunotech, Cardiacsense, Clinical Enterprise, Enspectra Health, Ibex, Implicity, Indica Labs, Metagenomi, Microport CRM, Onduo, Perkinelmer, Smoore.
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