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BioWorld - Sunday, May 31, 2026
Home » Topics » Infection » Coronavirus

Coronavirus
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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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Antibodies attacking SARS-CoV-2 virus

Oncimmune snags government funding for COVID-19 immune profiling tool

Oct. 13, 2020
By Nuala Moran
LONDON – Oncimmune Holdings plc has won government funding to apply its autoantibody biomarker technology to develop a COVID-19 immune profiling tool for triaging patients and predicting response to therapies and vaccines in development against the virus. The company will cross reference serum samples from 3,000 COVID-19 patients against its library of 800 SARS-CoV-2 related antigens and peptides to identify autoantibodies that characterize the range of immune responses to the infection.
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Other news to note for Oct. 13, 2020

Oct. 13, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced ICU Care, Biogx, Brain Scientific, Carebox, Cedars Sinai, Eos Imaging, Exagen, Facedrive, Immunitybio, Inspirata, Kitotech Medical, Labcorp, Livanova, Mymedic, Nanthealth, Nantomics, Oncimmune, Ppd, Primestone Capital, Qynapse, Roche, Spline.AI, Stryker, Toda Pharma, Transenterix, True Positive Medical Devices, Twist Bioscience, Visby Medical, Voycare, Wright Medical, Xilinx.
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Regulatory front

Medicare imaging stakeholders urge waiver of budget neutrality for MPFS

Oct. 13, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG: Medicare overpaid for facet-joint injections; FDA posts IIE policy for non-COVID tests.
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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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