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BioWorld - Sunday, May 10, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Jan. 13, 2022

Jan. 13, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Ascendis, Atai, Basilea, Cellular, Denali, Edesa, GSK, Hutchmed, Jeil, Mitsubishi, Novavax, Pharmather, Rockwell, SK, Vir.


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Other news to note for Jan. 13, 2022

Jan. 13, 2022
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuredit, Adagio, Advanz, Allecra, Amgen, Atyr, Bridgebio, Bristol Myers Squibb, Can-Fite, Captor, Endo, Halberd, Helmholtz , ITM, Journey Medical, Lysogene, N1, Prellis, Radius Health, Sarepta, Vir, Vyne, Zhittya.
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In the clinic for Jan. 13, 2022

Jan. 13, 2022
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alar, Arrowhead, Blade, Cyteir, Glaukos, I-Mab, IMV, Mesoblast, Pfizer, Revolution, Vaxxinity, Zai Lab.
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Australian flag on laptop screen with health professional

TGA issues guidance on software requirements for COVID-19 rapid antigen self-tests

Jan. 12, 2022
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released guidance for sponsors and manufacturers on regulatory requirements for software to be used with COVID-19 rapid antigen self-tests that are intended to analyze and interpret tests results.
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In the clinic for Jan. 12, 2022

Jan. 12, 2022
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abiomed, Caredx, Castle Biosciences, Electrocore, Glaukos, Pictor.
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Expectations for pharma R&D returns climb, but deeper view dulls shine

Jan. 12, 2022
By Nuala Moran
LONDON – There was a marked increase in the projected return on investment in pharma R&D in 2021, which rose to 7%, the highest level since 2014. That was up from a lowly 2.7% in 2020 and – even worse – 1.8% in 2019, according to the 12th annual report tracking ROI by the consultants Deloitte. But while 7% is a significant improvement, it is still below the projected ROI when the first edition of ‘Measuring the Return from Pharmaceutical Innovation’ was published in 2010, in response to concerns that pharma was spending more and more on R&D while getting less out. At that point, projected ROI was 10.1%.
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Regulatory actions for Jan. 12, 2022

Jan. 12, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aramis, Artelo, Biomica, Immunome, Phio, Polynoma, Snipr, Vertex, Wesana.


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Other news to note for Jan. 12, 2022

Jan. 12, 2022
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 2Seventy, Affibody, Amicus, Beyondspring, Bharat Biotech, Bristol Myers Squibb, Curateq, Heat, Iaso, Immix, Immuron, Innovent, Kintara, Lantern, Lokon, Merck, Mynd Life Sciences, Neogene, Neurocrine, Neurorx, Nuravax, Ocugen, Orion, Panavance, Plus, Relief, Revelation, Sana, Targovax, Xenon, Yumanity.
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In the clinic for Jan. 12, 2022

Jan. 12, 2022
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advaxis, Aldeyra, Amryt, Ascletis, Awakn, Antares, Applied Genetic Technologies, Basilea, Cansino, Myrtelle, Nascent, Pharmamar, Quantum Leap.
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FDA says Wirion embolic protection device recall a class I event

Jan. 11, 2022
By Mark McCarty
The FDA reported a class I recall of the Wirion embolic protection device by Cardiovascular Systems Inc. (CSI), of St. Paul, Minn., due to reports of nine instances of device malfunction. The agency said the filter portion of the device can be difficult to withdraw under some circumstances and thus lead to separation, although the FDA noted that no deaths have been reported in association with the issue despite the risk of embolization. The FDA’s device center also posted a Jan. 11 notification against the use of two tests by Lusys Labs Inc., of San Diego, for the SARS-CoV-2 virus.
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