The U.S. FDA cleared Respiree Pte. Ltd.’s 510(k) for its RS-001 cardio-respiratory wearable that measures respiration and offers passive cardio-respiratory monitoring.
Braveheart Bio Inc. is paying $65 million up front to license Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s oral hypertrophic cardiomyopathy drug candidate called HRS-1893.
Detailed data are expected later, but partners Biontech SE and Duality Biologics Co. Ltd. are celebrating a phase III interim analysis readout demonstrating that HER2-targeting antibody-drug conjugate (ADC) trastuzumab pamirtecan hit the primary endpoint of progression-free survival in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy.
“New explosions in biotechnology are allowing us to interrogate cancers at a very sophisticated level compared to before,” Dennis Slamon told audience members at the Global Bio Conference in Seoul, South Korea Sept. 3.
Propanc Biopharma, Inc. plans to acquire $100 million of Ethereum cryptocurrency over the next 12 months to accelerate its pipeline. The company is advancing its lead candidate, PRP, to enter a phase Ib trial in 30 to 40 advanced cancer patients with malignant solid tumors.
About two years since its founding, new company Radiance Biopharma Inc. signed a deal in which it could pay up to $1.165 billion to Novatim Immune Therapeutics Co. Ltd. for global rights outside of certain Asian countries to a bispecific nanobody antibody-drug conjugate that targets c-MET and EGFR to treat solid tumors.
Several South Korean biotech and biopharmaceutical companies completed IND submissions or won nods to start clinical trials in either the U.S. or South Korea, including SK Bioscience Co. Ltd., Genosco Inc., Pimedbio Inc., Sillajen Inc. and Ami Pharm Co. Ltd.
Argenica Therapeutics Ltd. saw its stock drop 56% following mixed results for its ARG-007 phase II Seancon trial in acute ischemic stroke patients undergoing endovascular revascularization, or thrombectomy.
Argo Biopharmaceutical Co. Ltd. and its RNAi work drew Novartis AG back to the table for a third time, as the companies entered a potential $5.2 billion deal involving cardiovascular-focused assets, including a right to first negotiation for BW-00112, an angiopoietin-like protein 3-targeting siRNA in phase II testing in severe hypertriglyceridemia.
Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).
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