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BioWorld - Sunday, March 29, 2026
Home » Topics » Clinical

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Stomach and intestine

GSK discontinues phase II trial of Immutep’s anti-LAG3 immunotherapy in ulcerative colitis

Jan. 26, 2021
By Tamra Sami
PERTH, Australia – Sydney-based Immutep Ltd. announced that Glaxosmithkline plc is discontinuing a phase II ulcerative colitis trial of its anti-lymphocyte activation gene-3 cell-depleting monoclonal antibody, derived from Immutep’s IMP-731 antibody that GSK licensed in 2010.
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Antibodies attacking SARS-CoV-2 virus

Regeneron and Lilly antibody studies produce positive COVID-19 data

Jan. 26, 2021
By Lee Landenberger
Regeneron Pharmaceuticals Inc. posted positive initial results from its ongoing phase III study of its monoclonal antibody cocktail, REGEN-COV (casirivimab and imdevimab), used as a passive vaccine, designed to provide immediate short-term passive immunity to prevent COVID-19 in people at high risk of infection due to household exposure to a COVID-19 patient. Eli Lilly and Co. reported upbeat news the same day, as the phase III Blaze-1 trial testing its antibody cocktail met its primary and key secondary endpoints.
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In the clinic for Jan. 26, 2021

Jan. 26, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Azurrx, Bioinvent, Concentric, Eucure, Gesynta, I-Mab, Isa, Imvax, Lilly, Marinus, Merck, Minoryx, Morphosys, Myovant, Orphomed, Qurient, Regeneron, Rhythm, Vir.
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Putting band-aid on finger

Babson Diagnostics takes blood panels to pharmacies

Jan. 25, 2021
By Annette Boyle
Driving to a laboratory for blood testing may soon be a thing of the past. Babson Diagnostics Inc. just completed a pivotal study of its new system for collecting and analyzing blood from a finger prick at a pharmacy counter. The results indicate that the microsample system provides comparable results to phlebotomist-drawn venipuncture blood samples.
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Woman lays on couch while wearing Nerivio on arm

Theranica’s Nerivio gets FDA nod for adolescent migraines

Jan. 25, 2021
By Meg Bryant
Theranica Bioelectronics Ltd. has snagged an expanded clearance from the U.S. FDA for use of its smartphone-controlled Nerivio device to treat migraines in adolescents. The new indication, for acute treatment of episodic or chronic migraine in people 12 years and older, is supported by a study published last month in the journal Headache.
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COVID-19 vaccine trial halted

Double blow in COVID-19 fight as Merck terminates two vaccine programs

Jan. 25, 2021
By Cormac Sheridan
Merck & Co. Inc. dropped a bombshell Jan. 25, announcing that it was terminating its two COVID-19 vaccine programs, V-590 and V-591, because neither demonstrated convincing levels of efficacy in phase I trials. As a relatively late entrant to the COVID-19 vaccine race, Merck, of Kenilworth, N.J., was never a leading contender in the effort to bring safe and efficacious vaccines to market. Even so, the failure of these programs is a significant setback, given the company’s scale and experience as a global vaccine manufacturer.
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In the clinic for Jan. 25, 2021

Jan. 25, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alector, Antios, Astrazeneca, Durect, Dynavax, Exelixis, Genentech, Macrogenics, Medigen, Synairgen, Zydus.
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Device image

Cairnsurgical treats first patient in pivotal trial of 3D imaging system for breast cancer surgery

Jan. 22, 2021
By Annette Boyle
One in five breast cancer conserving surgeries leaves behind some of the tumor. That means patients must schedule a second surgery and then endure additional pain, infection risk, recovery time and cost. Cairnsurgical Inc.'s Breast Cancer Locator system may change that by providing 3D tools that enable surgeons to precisely tailor resection to the shape, size and location of each tumor.
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Illustration of vascular system in the legs

New data take another bite out of Katsansos, but registries now more topical

Jan. 22, 2021
By Mark McCarty
The storm of controversy over the use of paclitaxel in devices for the peripheral vasculature had a dramatic effect on utilization, but a new study coming out of Sweden seems to have helped further ease concerns about purported mortality associated with this antiproliferative. While this unplanned interim analysis lends yet more support to the view that the mortality signal in the so-called Katsanos paper did not reflect a true biological finding, the net effect of the controversy has prompted a call for a registry that might eliminate some statistical noise that had a significant and harmful impact on patients.
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Clinical, regulatory data surged in 2020; approvals on target with pre-pandemic years

Jan. 22, 2021
By Karen Carey
Clinical and regulatory data reported in 2020 are up 24% and 47%, respectively, over the prior year, proving to be the busiest 12 months on record for the biopharma industry, in spite of, or perhaps because of, a deadly global pandemic.
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