BioSpace News Archive

Positive results from the pivotal TROPION-Breast01 phase 3 trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to investigator’s choice of chemotherapy in patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.

Positive results from the ongoing DESTINY-PanTumor02 phase 2 trial showed that ENHERTU® (trastuzumab deruxtecan) continued to demonstrate clinically meaningful and durable responses, leading to a clinically meaningful survival benefit in previously treated patients across multiple HER2 expressing advanced solid tumors.

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced that positive initial data from the first-in-human study evaluating JK08 in adults with solid tumors were presented in a poster session during the European Society of Medical Oncology Annual Congress 2023.

GE HealthCare (Nasdaq: GEHC) will showcase some of the latest innovations designed to help clinicians in the treatment of cardiovascular disease at the 2023 Transcatheter Cardiovascular Therapeutics conference (TCT) which will take place October 23-26 in San Francisco, CA.

Gel4Med, an innovative biomaterials company, is proud to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its first biosynthetic matrix products, G4Derm and G4Derm Plus.

NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation

The Alzheimer’s Drug Discovery Foundation’s (ADDF) Diagnostic Accelerator (DxA) today announced the launch of SpeechDx, the first longitudinal study aimed at creating the largest repository of speech and voice data to help accelerate the detection, diagnosis and monitoring of Alzheimer’s disease.

CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announced today the presentation of findings from its post-hoc analysis of the Phase 3 ENHANCE study of seladelpar for the treatment of primary biliary cholangitis (PBC), showing baseline intensity of patient-reported pruritus was associated with higher levels of serum IL-31.

Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it is scheduled to report third quarter results on November 2, 2023 at 4:00 PM Eastern Time.

Xtant Medical Holdings, Inc. announced that it has acquired the nanOss production operations from RTI Surgical, Inc., a leading CDMO in regenerative medicine.