BioSpace News Archive

Selux Diagnostics, a biotech startup in Boston whose mission is to combat superbug infections and antimicrobial resistance (AMR), announced it has received its second 510(k) clearance on the Selux Next Generation Phenotyping (NGP) System from the U.S. Food and Drug Administration (FDA) for its proprietary NGP Gram-Negative Panel.

Trefoil Therapeutics, a clinical-stage biotechnology company focused on developing novel new therapeutic agents to treat corneal diseases, today announced a series of data presentations demonstrating the potential use of TTHX1114 to protect endothelial cells at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in New Orleans.

NASDAQ IVCP Swiftmerge Acquisition Corp announced the signing of a non-binding letter of intent for a business combination with HDL Therapeutics Inc., a privately held commercial stage biotech company with an FDA-approved cardiovascular therapy for reducing coronary atheroma in homozygous familial hypercholesterolemia patients.

SimonMed is proud to announce we will offer GE HealthCare’s radiopharmaceutical diagnostic tracer, DaTscan™, with DaTQUANT™ nationally starting immediately in all of our markets.

Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, announces a scientific presentation at the 2023 Association for Research in Vision and Ophthalmology annual meeting in New Orleans, LA.

Texas Biomedical Research Institute’s 3rd Global Health Symposium on May 18 and 19 will convene experts from across the nation and the world to discuss how community, trust and science can help build health equity.

QIAGEN announced that its QIAstat-Dx syndromic testing solution is expected to be available soon for use in Japan with a SARS-CoV-2 Respiratory Panel that can detect more than 20 pathogens from a single patient sample.

Sernova Corp. announced the presentation of preclinical data supporting the anticipated 2024 IND submission and planned Phase 1/2 clinical trial of Evotec SE’s iPSC-derived ILCs in combination with Sernova’s implantable Cell Pouch device for the treatment of patients with T1D.

MaaT Pharma reported that the U.S. Food and Drug Administration has lifted the clinical hold and cleared the Investigational New Drug application to initiate in the U.S. an open-label, single arm Phase 3 pivotal clinical trial evaluating the safety and efficacy of MaaT013 to treat gastrointestinal acute Graft-versus-Host Disease as a third line of treatment.

Ipsen, a global specialty-driven biopharmaceutical company, announced the appointment of Sandra Silvestri, M.D., Ph.D., as EVP, Chief Medical Officer and Head of Global Medical Affairs, Patient Safety and Patient Affairs, effective 5 May 2023.