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.
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.
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.
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.
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.
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.
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.