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Technology & Devices

Natera to Partner with AMAL Therapeutics on Clinical Trial Using Signatera MRD Test to Assess Treatment Response to Colorectal Cancer Vaccine

SAN CARLOS, Calif., March 26, 2019 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, will partner with AMAL Therapeutics on a clinical trial focused on stage IV colorectal cancer. This study adds to the growing number of pharmaceutical trials using Natera’s Signatera™ molecular residual disease …

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CRISPR-Chip Enables Digital Detection of DNA without Amplification

CLAREMONT, Calif., March 25, 2019 /PRNewswire/ — Researchers have found multiple applications for the CRISPR (Clustered Regularly Interspersed Short Palindromic Repeats) gene editing technology since it came into use by the scientific community. Keck Graduate Institute (KGI) Assistant Professor and University of California, Berkeley Visiting Scientist Kiana Aran is the …

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Impulse Dynamics Receives FDA Approval for Breakthrough Optimizer Smart System Delivering CCM Therapy for Treatment of Heart Failure

ORANGEBURG, New York, March 21, 2019 /PRNewswire/ — Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System (link to FDA announcement:  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634103.htm). Designed to address …

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Alexion and Affibody Announce Partnership to Co-Develop Anti-FcRn Affibody Molecule

BOSTON & SOLNA, Sweden–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Affibody AB today announced a partnership to co-develop ABY-039 for rare Immunoglobulin G (IgG)-mediated autoimmune diseases. Currently in Phase 1 development, ABY-039 is a bivalent antibody-mimetic that targets the neonatal Fc receptor (FcRn). ABY-039 has been specifically designed to combine Affibody’s protein …

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FDA Grants Breakthrough Device Designation to Fresenius Medical Care’s Software for Fluid Management During Hemodialysis

WALTHAM, Mass., March 14, 2019 /PRNewswire/ — Fresenius Medical Care North America’s Renal Therapies Group, the leading provider of kidney care products, announced today that the U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to its computer-assisted ultrafiltration (UF) control software currently in development to improve fluid …

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Merck KGaA Collaborates with Iktos for Generative Artificial Intelligence Technology

Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced a collaboration agreement with Iktos, for the use of its generative modelling artificial intelligence (AI) technology, in order to facilitate the rapid and cost-effective discovery and design of promising new compounds. “This agreement is another illustration of how …

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Biocept Expands its Pathology Partnership Offering for Liquid Biopsy with the Addition of Several Key Services

SAN DIEGO, March 13, 2019 /PRNewswire/ — Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, announces that it has expanded its pathology partnership platform, EmpowerTCTM, to now offer local …

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Hematogenix Launches FDA Approved Companion Diagnostic Immuno-oncology Test for Triple-Negative Breast Cancer

TINLEY PARK, Ill., March 12, 2019 /PRNewswire/ — Hematogenix®- a global leader in the field of integrated pathology services for drug development and immuno-oncology testing, today announced the launch of the companion diagnostic test for the drug TECENTRIQ®. On March 8, 2019, the U.S. Food and Drug Administration (FDA) approved …

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Microsoft Research and Oxford Biomedica Collaborate to Improve Gene Therapy Using Intelligent Cloud and Machine Learning

Oxford, UK – 12 March 2019: Oxford Biomedica plc (LSE:OXB), a leading gene and cell therapy group, today announces that it has entered into a research and development collaboration with Microsoft Research to improve the yield and quality of next generation gene therapy vectors using the cloud and machine learning. Cell …

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Biocartis and Bristol-Myers Squibb Sign Collaboration Agreement for MSI Testing with Immuno-Oncology Therapies

Mechelen, Belgium, 12 March 2019 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced the signing of a collaboration agreement with Bristol-Myers Squibb Company (NYSE: BMY), a global biopharmaceutical company, aimed at the potential registration as a companion diagnostic and use of …

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