BioSpace News Archive

MedAlliance has announced enrolment of the first two patients in the PRISTINE registry with SELUTION SLR™ 018 DEB for the treatment of patients with Below The Knee disease (Chronic Limb Threatening Ischemia). This is the first DEB accepted by the FDA for its “Breakthrough Program”. SELUTION SLR (Sustained Limus Release) is a nov

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today introduced two new SARS-CoV-2 antibody tests: the Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test, and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test. These new tests for detecting COVID-19 antibodies expand the company’s leading

Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases

GE Healthcare today announced U.S. FDA 510k clearance for its Ultra Edition package on Vivid 1 cardiovascular ultrasound systems, which includes new features based on artificial intelligence (AI) that enable clinicians to acquire faster, more repeatable exams consistently. Methodical assessments of heart function are key in echocardiography but can be tedious and time-consuming to acquire. High quality data acquisition and

Phase 1 development partner Janssen to present data showing VE202 microbiome-derived bacterial strains rapidly, abundantly and durably colonize the gut of healthy volunteers CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Vedanta Biosciences , a leading clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria, today announced that additional pharmacoki

IQVIA™ (NYSE: IQV), in scientific partnership with the U.S. Food and Drug Administration, will provide agile analytics from IQVIA’s CARE Project COVID-19 registry to support better understanding of how people in the community are affected by exposure to the coronavirus. IQVIA’s research will show what symptoms individuals experience, the length and severity and whether any medications or

The FAST-01 (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases) study is a significant milestone in the development of FLASH therapy - FLASH therapy delivers radiation at ultra-high dose rates and may be over 100 times faster compared to conventional radiation therapy - The study will use Varian’s ProBeam® proton particle accelerator modified with a specialized module with FLASH capabilities - Trial to evaluate patients with bo

SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of two posters at the Nurse Practitioners in Women Health’s (NPWH) 23rd Annual Premier Women’s Healthcare Virtual Conference to be held from October 15 – October 17, 2020. The posters will highlight the robust Phase 3 data on ibrexafungerp, a novel

Alexion Receives FDA Approval for New Advanced Formulation of ULTOMIRIS ® (ravulizumab-cwvz) with Significantly Reduced Infusion Time – New 100 mg/mL formulation will reduce infusion time by approximately 60 percent, lessening the burden on patients – – ULTOMIRIS is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) – BOSTON--( BUSINESS WIRE )-- Alexion Pharmaceuticals, Inc.

Avadyne Health, the patient liability resolution expert, is pleased to announce it has taken the Patient Financial Advocate Pledge and been awarded the Seal indicating patient excellence in financial communication by the American Association of Healthcare Administrative Management (AAHAM) and the National Patient Financial Advocate Task Force.