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BioWorld - Monday, April 20, 2026
Home » Topics » Clinical

Clinical
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Red and white blood cells

FDA to ring ide-cel bell; BCMA in play with Allogene on mezzanine

March 5, 2021
By Randy Osborne
As the March 27 PDUFA date nears for idecabtagene vicleucel (ide-cel, also known as BB-2121), the B-cell maturation antigen (BCMA)-directed chimeric antigen receptor CAR T-cell therapy from Bristol Myers Squibb Co. and Bluebird Bio Inc., investors are looking with increased favor on the approach.
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Target with off-center arrow

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

March 5, 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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In the clinic for March 5, 2021

March 5, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apellis, Aerpio, Bergenbio, Bioeclipse, Brii, Can-Fite, Eli Lilly, GT, Immutep, Longeveron, Macrogenics, Ocuphire, Seelos, Tersera.
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Liver tumor treatment conceptual illustration

Histosonics tests sonic beam therapy for liver tumors

March 4, 2021
By Mary Ellen Schneider
Histosonics Inc. is testing its investigational histotripsy technology to destroy liver tumors in two clinical trials in the U.S. and Europe, with the goal of seeking regulatory clearance for the platform in 2022. The technology uses the science of histotripsy, a form of therapeutic focused ultrasound, to mechanically destroy targeted primary and metastatic liver tumors from outside the body.
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Silhouettes

Researchers ID new method to monitor schizophrenia drug in blood

March 4, 2021
By David Ho
HONG KONG – Researchers at Ben-Gurion University of the Negev (BGU) in Israel have developed a way to instantly monitor blood levels of the antipsychotic drug clozapine. BGU’s solution is based on an electrochemical microsensor developed by Hadar Ben-Yoav from BGU’s Department of Biomedical Engineering and Ilse Katz Institute for Nanoscale Science and Technology.
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Cuba mask and syringe

Cuba’s Soberana 02 SARS-CoV-2 vaccine candidate moves to phase III trials

March 4, 2021
By Sergio Held
CAJICA, Colombia – Cuba’s Center for the State Control of Drugs, Equipment and Medical Devices gave the green light March 3 for phase III trials of a domestically developed COVID-19 vaccine candidate, even though very little peer-reviewed information has been published about it.
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In the clinic for March 4, 2021

March 4, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, Allarity, Apollomics, Cyclo, Dicerna, Diamyd, Dnatrix, Galapagos, Landos, Lilly, Mallinckrodt, Provention, Ridgeback, Roche, TFF, VBL, Ysopia.
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In the clinic for March 3, 2021

March 3, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Arena, Azura, Bharat, Biomarin, Forendo, GSK, Incyte, Karolinska, Lilly, Longeveron, Maker, Morphosys, Ocugen, Prometheus, Reveragen, Santhera, Spectrum, Vir.
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Ascletis joins Madrigal and Viking in global race for THR-β agonist for NASH

March 2, 2021
By Elise Mak
Liver disease specialist Ascletis Pharma Inc. said its nonalcoholic steatohepatitis (NASH)-focused subsidiary, Gannex Pharma Co. Ltd., will start global development of its oral THR-β agonist, ASC-41, after it obtained an IND approval from the FDA based on positive phase I data generated in China.
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Silhouettes

Neurocrine schizophrenia thesis intact post-Interact? Opinions differ on phase II data

March 2, 2021
By Randy Osborne
San Diego-based Neurocrine Biosciences Inc.’s good-and-bad top-line phase II data with d-amino acid oxidase inhibitor luvadaxistat, also known NBI-1065844 and TAK-831, in schizophrenia likely came as little surprise to many, given earlier experience in the general pathway.
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