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BioWorld - Monday, February 9, 2026
Home » Topics » Clinical

Clinical
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Researchers developing test for earlier diagnosis of Parkinson’s

March 11, 2021
By Nuala Moran
LONDON – New research shows it is possible to diagnose Parkinson’s disease by mass spectrometry analysis of sebum samples taken with a simple skin swab, and that the same technique has potential to be used for diagnosing COVID-19. In a paper published in Nature Communications on March 11, 2021, scientists and clinicians in the U.K. and the Netherlands describe using high resolution mass spectrometry to profile the chemical signature of lipids and other biomarkers in sebum from Parkinson’s patients and show how these exhibit subtle but fundamental changes as the disease progresses.
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GM-CSF

Immune response research shows GM-CSF plays role in COVID-19 severity

March 11, 2021
By Nuala Moran
LONDON – The largest study of its kind to date has identified new biomarkers of inflammation that are both indicators of severe COVID-19 infection and distinguish it from severe influenza.
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Entera Bio shares lead U.S. market with new phase II osteoporosis data

March 11, 2021
By Michael Fitzhugh
Shares of Israeli drug delivery specialist Entera Bio Ltd. (NASDAQ:ENTX) led the U.S. market March 11, in both percentage gain and volume, climbing 152.5% to $4.04 after a report that its oral parathyroid hormone candidate, EB-613, significantly boosted levels of P1NP, a biomarker indicating new bone formation vs. placebo at three months in an ongoing phase II osteoporosis study.
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Coronavirus and antibodies

‘Profound efficacy’ for the Vir-GSK COVID-19 antibody prompts EUA talk as Roche-Gilead fails

March 11, 2021
By Lee Landenberger
Positive COVID-19 efficacy numbers from Vir Biotechnology Inc. and Glaxosmithkline plc (GSK) has prompted them to immediately seek an emergency use authorization (EUA) with the FDA and similar authorizations in other countries for their monoclonal antibody, VIR-7831. Meanwhile, the phase III Remdacta study of Actemra/RoActemra (tocilizumab) plus Veklury (remdesivir) vs. placebo plus Veklury, from Roche Holding AG and Gilead Sciences Inc., missed its primary endpoint in treating hospitalized patients with severe COVID-19 pneumonia receiving standard of care.
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Azura Ophthalmics advances to registration study on positive phase II results in Meibomian gland disfunction

March 11, 2021
By Tamra Sami
PERTH, Australia – Sydney-based Azura Ophthalmics Ltd. has moved into a registration trial following positive phase II results for lead candidate AZR-MD-001 in Meibomian gland dysfunction, the leading cause of dry eye disease.
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In the clinic for March 11, 2021

March 11, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aelix, Algernon, Biohaven, Bioventus, Entera, Evgen, Formosa, Genentech, Gilead, GSK, Kintor, Marinomed, Moderna, Novartis, Renibus, Rigel, Roche, Sosei, Sun, Transgene, Vicore, Vir.
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Affimed moves ahead with its T-cell lymphoma study

March 10, 2021
By Lee Landenberger
Following an interim futility analysis, Affimed NV has decided to continue enrolling its phase II, registration-directed study of AFM-13, a tetravalent, bispecific innate cell engager, as a monotherapy for treating relapsed or refractory CD30-positive peripheral T-cell lymphoma.
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Sickle cell illustration

Bluebird seeking to resume SCD trials, clear concerns about vector

March 10, 2021
By Michael Fitzhugh
Just weeks after two unexpected cases of blood cancer landed trials of its investigational gene therapies for sickle cell disease (SCD) and beta-thalassemia on FDA-issued clinical holds, Bluebird Bio Inc. said it's talking to regulators about their resumption after what RBC analyst Luca Issi called a "partial exoneration" of the BB-305 lentiviral vector shared between the medicines.
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In the clinic for March 10, 2021

March 10, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adicet, Affimed, Alar, Aligos, Beigene, Eli Lilly, Genentech, Gilead, Impact, VBI, Vertex, Viiv, Viriom.
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Target with off-center arrow

Bio-Thera terminates HER2 and Trop2 ADCs and PD-1 inhibitor programs

March 9, 2021
By Elise Mak
In an unusual move for a Chinese company, Bio-Thera Solutions Ltd. terminated the clinical development of its Trop2 antibody-drug conjugate (ADC), BAT-8003, and its PD-1 monoclonal antibody, BAT-1306, a month after it halted the phase III-stage HER2-ADC candidate BAT-8001.
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