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BioWorld - Saturday, December 27, 2025
Home » Topics » Infection » Coronavirus

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Regulatory front

MHRA: Trial supply chains need to prepare for Brexit changes

Dec. 14, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: Health Canada to extend COVID-19 flexibilities; USTR seeking input on nations with poor IP protections.
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Regulatory actions for Dec. 14, 2020

Dec. 14, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acceleron, Amag, Ascletis, Antengene, Astrazeneca, Avelas, Biontech, Codagenix, Daiichi Sankyo, EMD, Gamida, Gannex, Graphite, Legend, Merck KGaA, Mindmed, Open Orphan, Pfizer, Sobi.
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Other news to note for Dec. 14, 2020

Dec. 14, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3Sbio, ADC, Adelia, Allarity, Alzecure, Anixa, Ascentage, Ashvattha, Brainstorm Cell, Crispr, Cybin, Enzolytics, Eureka, Havn, Hemab, Hummingbird, Immuno-Precise, Intellia, Litevax, Mosaic, Neuraxpharm, Neurorx, Novo Nordisk, Overland, Pharmacyte, Phathom, Reviva, Spectrum, Teon, Unicycive, Verseau, Vivus.
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In the clinic for Dec. 14, 2020

Dec. 14, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerpio, Amarin, Arvinas, Astrazeneca, Bellus, Biontech, Biophytis, Caladrius, Cytokinetics, Curevac, Daiichi, Freeline, Innovent, Junshi, Kintor, Lilly, Mitsubishi Tanabe, Novartis, Odonate, Pfizer, Polyphor, Poxel, Puma, RDIF, Sanofi, Synlogic, TCR2.
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X-ray scans with highlighted regions

Partners collaborate with Boston Children’s Hospital on ‘explainable’ AI-driven technology

Dec. 11, 2020
By David Godkin
TORONTO – Waterloo, Ontario-based DarwinAI Corp. and Raleigh, N.C.-based Red Hat Inc.are developing a suite of deep neural networks for COVID-19 detection and risk stratification via chest radiography in cooperation with Boston Children’s Hospital. DarwinAI designed COVID-Net as “explainable” artificial intelligence (AI) that illuminates the inner workings of AI-driven medical technologies and promptly offered it on an open-source platform for the broader hospital community.
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Digital illustration of U.S., coronavirus

Harvard’s Mina: Props to HHS’s Giroir for assisting on antigen test development

Dec. 11, 2020
By Mark McCarty
Michael Mina, assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, again criticized the U.S. FDA for taking a conventional regulatory approach to rapid antigen tests for the pandemic. However, not everyone at the FDA’s parent department deserves brickbats. Mina said Assistant Secretary for Health Brett Giroir deserves a lot of credit for assisting in the effort to stand up pilot studies for rapid antigen tests that could be used to restore the U.S. economy even in the absence of a fully rolled-out vaccination campaign.
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Regulatory actions for Dec. 11, 2020

Dec. 11, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode.
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Other news to note for Dec. 11, 2020

Dec. 11, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akoya Biosciences, Biocogniv, Dermtech, Djo, Litecure, Nanalysis, Nanovibronix, Neovasc, Pear Therapeutics, Roche, Rs2d, Spinal Elements, Ultra Pain Products.
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COVID-19 vaccine vials

Sanofi-GSK delay their COVID-19 vaccine development as Astrazeneca partners with Russia

Dec. 11, 2020
By Lee Landenberger
The Sanofi SA-Glaxosmithkline plc COVID-19 vaccine program is taking a step backward to recalibrate as weak interim phase I/II data showed an insufficient response in patients age 50 and older. The step is a large one, delaying a potential launch until mid-2021 at the earliest and the end of next year at the latest.
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Coronavirus and DNA

New research on COVID-19 genetic variants will guide development of treatments

Dec. 11, 2020
By Nuala Moran
LONDON – A study of genetic variants in patients with life-threatening COVID-19 has shed light on the mechanisms that underpin severe disease, uncovered new drug targets and pointed to approved drugs, including JAK inhibitors and phosphodiesterase type 4 inhibitors, as therapies that could aid recovery.
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