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BioWorld - Sunday, January 12, 2025
Home » Topics » Infection » Coronavirus

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Regulatory front for Feb. 2, 2021

Feb. 2, 2021
By Mark McCarty
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDC reports on cases, sequencing; NICE says savings seen with Cytosorb; IP at issue as WTO pushes for global pandemic effort; Researcher gets prison time for trade secret theft; USPTO responds to COVID-19 challenge.
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Other news to note for Feb. 2, 2021

Feb. 2, 2021
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuvein, Adapthealth, Aerocare, Aegea Medical, Biosig, Cardiofocus, Chronix, Coopersurgical, Diagnos, Electrocore, Evestra, Geniemd, Horiba, Intellatriage, Japan Lifeline, Kanhoor Medical, Lidco, Masimo, Mayo Clinic, Medtest, Myriad Genetics, Novacyt, Omega Laboratories, Oncocyte, Predictive Oncology, Vivos Therapeutics.
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Sputnik V vaccine efficacy confirmed, as developers tout safety, ease of distribution

Feb. 2, 2021
By Nuala Moran
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LONDON –The Russian COVID-19 vaccine Sputnik V now has validation from the Western science establishment, after The Lancet published full interim results of the phase III trial on Feb 2. The peer-reviewed paper confirms the 91%-plus efficacy that the vaccine’s developer, Gamaleya National Center of Epidemiology and Microbiology, claimed in its own announcement of the results in December.
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Regulatory front

IP at issue as WTO pushes for global pandemic effort

Feb. 2, 2021
By Mari Serebrov
No Comments
The latest global regulatory news, changes and updates affecting biopharma, including: Researcher gets prison time for trade secret theft; USPTO responds to COVID-19 challenge.
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Regulatory actions for Feb. 2, 2021

Feb. 2, 2021
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, BMS, Cerecor, Chinook, Durect, Kintor, Mustang, Neurmedix, Paxmedica, Russian Direct Investment Fund, Sesen, SQZ, VBI Vaccines.
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Other news to note for Feb. 2, 2021

Feb. 2, 2021
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adagene, Adamas, Adverum, Aeterna, Aikido, Annovis, Ascentage, Bharat Biotech, Biovaxys, Can-Fite, Cevec, Circ, Coherus, Engrail, Evozyne, Exelixis, Genentech, Harbour Biomed, Ilias, Immunome, Junshi, Maia, Mati, Max, Moleculin, Neurocycle, Novelion, Ocugen, Ono, Oragenics, Paragon, Probiogen, Q, Regeneron, Ribon, Rznomics, Viewpoint Molecular, Virios, X-Chem, Zebiai, Zydus.
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In the clinic for Feb. 2, 2021

Feb. 2, 2021
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abpro, Arch, Arena, Biomx, BMS, Bridgebio, Calcimedica, Cassava, Chemomab, Curis, Daiichi, Diurnal, Exonate, Gedea, Gemini, Immunovant, Janssen, Kira, Pharnext, Pinteon, RDIF, Secura, Selva, Tiziana, Travere, Verona.
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Other news to note for Feb. 1, 2021

Feb. 2, 2021
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arcus, Aicuris, Algernon, Akari, Biontech, Cognition, Curevac, Dynavax, Eversana, Gilead, Gritstone, Iterum, Kamada, Metrion, Noveome, Nyrada, Pfizer, Rentschler, Sonnet, Sosei, Sumitomo Dainippon, Titan, Valneva, Vir.
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Digital imaging technology

NICE publishes guidelines for AI use in select imaging procedures

Feb. 1, 2021
By Nuala Moran
No Comments
LONDON – The U.K. National Institute for Health and Care Excellence (NICE) has published new advice on how and when artificial intelligence (AI) could be applied to the interpretation of mammograms and chest computer tomography images, in a move that is intended to set the ground rules for the uptake of these technologies. In population breast screening, NICE looked at how five AI systems could be used to pick out mammography images that need further assessment, supporting qualified radiologists in their interpretation.
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Other news to note for Feb. 1, 2021

Feb. 1, 2021
No Comments
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Althea UK and Ireland, Ambu, Ascensia, Avails Medical, Cadwell Industries, Cardiovascular Systems, Chansu Vascular Technologies, Circularity Healthcare, Earlysense, Fuse Medical, Hillrom, Innova Medical Group, Laborie Medical Technologies, Mayo Clinic, Orthovestments, Roche, Seegene, Senseonics, Setpoint Medical, Urotronic.
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