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BioWorld - Tuesday, July 14, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Jan. 26, 2021

Jan. 26, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Biontech, Cardiff, Cidara, Edesa, Faron, Fosun, Immunicum, Meiragtx, Merck, Mundipharma, Nanoscope, OS Therapies, Recordati, Veralox, Vertex.
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Other news to note for Jan. 26, 2021

Jan. 26, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief:Aclipse, Adagio, Adamis, Adial, Allarity, Amarin, Aslan, Atai, Bicycle, Bridgebio, Curadigm, Eidos, Entasis, Enzychem, Galmed, Health Net, Humanetics, I-Mab, Janssen, Moderna, Morphosys, Nanobiotix, Pharmacyte, Sanofi, Silo, Synaptogenix, Therapeutic Solutions, Vaxart.
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In the clinic for Jan. 26, 2021

Jan. 26, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Azurrx, Bioinvent, Concentric, Eucure, Gesynta, I-Mab, Isa, Imvax, Lilly, Marinus, Merck, Minoryx, Morphosys, Myovant, Orphomed, Qurient, Regeneron, Rhythm, Vir.
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Other news to note for Jan. 25, 2021

Jan. 25, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Artificial, Brainsway, Emed, Flurotech, Gaelan, Medtechnica, Nanocomposix, Renalsense, Roche, Sysmex, Therapeutic Solutions International, Thermo Fisher Scientific, Volitionrx.
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In the clinic for Jan. 25, 2021

Jan. 25, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Becton Dickinson.
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T cells

With enviable liquidity, Tscan on solid ground; $100M for dual oncology push

Jan. 25, 2021
By Randy Osborne
Tscan Therapeutics Inc. CEO David Southwell told BioWorld that his firm’s series C financing of $100 million will allow two IND filings in liquid tumors this year and three – possibly more – in solid tumors starting next year. “We’ll be filing a lot of INDs in solid tumors,” he said. The Waltham, Mass.-based firm works with T-cell receptor-engineered T-cell therapies.
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Green approved stamp

Pfizer vaccine receives provisional approval in Australia

Jan. 25, 2021
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd. for its COVID-19 vaccine, branded Comirnaty, making it the first COVID-19 vaccine to receive approval in Australia.
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Coronavirus mutation illustration

New COVID-19 variants challenging vaccine makers amid rollout

Jan. 25, 2021
By Nuala Moran
LONDON – There is “a realistic possibility” that infection with the B 1.1.7 variant of SARS-CoV-2 is associated with a 30% to 40% increased risk of death compared to earlier variants of the virus, according to scientists on the U.K. government’s New and Emerging Respiratory Virus Threats Advisory Group. That conclusion is based on studies by three university groups, linking community PCR testing to mortality.
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COVID-19 vaccine trial halted

Double blow in COVID-19 fight as Merck terminates two vaccine programs

Jan. 25, 2021
By Cormac Sheridan
Merck & Co. Inc. dropped a bombshell Jan. 25, announcing that it was terminating its two COVID-19 vaccine programs, V-590 and V-591, because neither demonstrated convincing levels of efficacy in phase I trials. As a relatively late entrant to the COVID-19 vaccine race, Merck, of Kenilworth, N.J., was never a leading contender in the effort to bring safe and efficacious vaccines to market. Even so, the failure of these programs is a significant setback, given the company’s scale and experience as a global vaccine manufacturer.
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Regulatory actions for Jan. 25, 2021

Jan. 25, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Albireo, Arrowhead, Astrazeneca, Aurinia, Beigene, EMD Serono, Eusa, Iterum, Junshi, Pfizer, Waymade.
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