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BioWorld - Sunday, January 11, 2026
Home » Topics » Coronavirus, BioWorld

Coronavirus, BioWorld
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Regulatory front

FDA pilot programs aim to create manufacturer rating system

Oct. 15, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma.
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Testing of Lilly's COVID-19 antibody continues despite paused trial

Oct. 14, 2020
By Michael Fitzhugh
Despite an NIH move to pause enrollment in a trial testing Eli Lilly and Co.'s COVID-19 antibody candidate, LY-CoV555, after a participant's unexplained illness, at least three other studies of the candidate remain underway, the company said Oct. 14.
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Health professional touching screen, digital/medical icons

UK Bioscience Forum: COVID-19 amplifying importance of real world data

Oct. 14, 2020
By Nuala Moran
Tracking the pandemic in all its manifestations – from symptoms and spread, to viral genomics and repurposing drugs – has massively increased appreciation of the importance of real world data, with significant implications for the future of drug discovery and clinical development, the use of patient data and health care as a whole.
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Regulatory actions for Oct. 14, 2020

Oct. 14, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Biohaven, Direct, Enlivex, Harmony, Moderna, Orca, Redhill, Scynexis, Sorrento, Taysha Gene, Tevogen, Y-mabs.
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Other news to note for Oct. 14, 2020

Oct. 14, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arvinas, Bioclonetics, Blue Oak, Boehringer, Denali, Dendreon, Emmaus, Enzolytics, Exscientia, Gilead, Immunomedics, Kadmon, Lactiga, Mediwound, Moberg, Novan, Oxford, Passage, Polyphor, Qihan, Redhill, Rezolute, Secarna, Vaxart, Xoma.
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In the clinic for Oct. 14, 2020

Oct. 14, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amolyt, Anaptysbio, Auris, Azurrx, Basilea, Bone Therapeutics, Celldex, Cyclerion, Cytoagents, Evelo, Horizon, Ionis, Linnaeus, Mesoblast, Noxxon, Revance, Shasqi, TLC.
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Microscope image of SARS-CoV-2

Intervenn Biosciences IDs COVID-19 risk biomarkers using glycoproteomics

Oct. 13, 2020
By Meg Bryant
Intervenn Biosciences said it has identified stark differences in the glycoproteomic profile of COVID-19 patients who became very sick and people infected with the SARS-CoV-2 virus who were either asymptomatic or experienced only minimal effects. The contrast could help clinicians better understand the biological mechanisms of the disease and triage patients at risk of responding detrimentally to early treatments and more intensive care.
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Janssen’s vaccine candidate

J&J pauses COVID-19 vaccine trial after unexplained illness

Oct. 13, 2020
By Michael Fitzhugh
Johnson & Johnson said it has temporarily paused further dosing of its adenoviral vector-based COVID-19 vaccine candidate, JNJ-78436735, due to an unexplained illness in a study participant. Trial enrollment is also on hold while the company awaits a recommendation on how to proceed from the study's data safety monitoring board.
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NIH trial testing Lilly antibody against COVID-19 paused

Oct. 13, 2020
By Michael Fitzhugh
An NIH-sponsored phase III trial testing Eli Lilly and Co.'s SARS-CoV-2 neutralizing antibody candidate, LY-CoV555, alongside the Gilead Sciences Inc. antiviral Veklury (remdesivir) has been paused at the request of its data safety monitoring board, the company told BioWorld.
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Coronavirus, lungs

Apogenix adds cancer drug asunercept to COVID-19 fight; phase II study underway

Oct. 13, 2020
By Nuala Moran
LONDON – Apogenix GmbH has added its CD95 ligand inhibitor, asunercept, to the band of cancer immunotherapies that are being repurposed to treat the most severe effects of COVID-19 infection.
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