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Technology & Devices

FDA Approves Hologic’s Genius 3D Mammography Exam as the Only Mammogram Superior for Women with Dense Breasts

MARLBOROUGH, Mass., June 7, 2017 /PRNewswire/ — Hologic, Inc. (Nasdaq: HOLX) announced today that the Genius™ 3D Mammography™ exam is now the only mammogram that is FDA-approved as superior to standard 2D mammography for routine breast cancer screening of women with dense breasts.1 The Genius exam has been commercially available …

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Bristol-Myers Squibb and Qiagen Agree to Use NGS Technology to Develop Gene Expression Profiles for Immuno-Oncology Therapies

NEW YORK & HILDEN, Germany–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) and QIAGEN (NASDAQ:QGEN; Frankfurt Prime Standard:QIA) have signed an agreement to explore the use of next-generation sequencing (NGS) technology to develop gene expression profiles (GEPs) as predictive or prognostic tools for use with Bristol-Myers Squibb novel immuno-oncology (I-O) therapies in cancer …

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FDA Approves Roche’s Companion Diagnostic to Identify ALK-Positive NSCLC Patients

Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Novartis drug ZYKADIA (ceritinib). The VENTANA ALK (D5F3) Assay is the …

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ImmunoGen and Sanofi Amend License Agreements Covering All Sanofi Compounds Using ImmunoGen’s Technology

WALTHAM, Mass.–(BUSINESS WIRE)–ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the Company and an affiliate of Sanofi have amended their license agreements covering all compounds in development by Sanofi using ImmunoGen’s technology. Under the terms of …

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Shire’s Hemophilia Candidate Using Xenetic Technology Platform Fails in Phase 1/2 Trial

LEXINGTON, Mass.–(BUSINESS WIRE)–Xenetic Biosciences, Inc. (NASDAQ:XBIO) (“Xenetic” or the “Company”), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, announced today that it has received an update on the Phase 1/2 clinical study conducted by its partner Shire, evaluating …

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X-Chem and Vertex Enter Multi-Target Genetic Disease Partnership

WALTHAM, Mass.–(BUSINESS WIRE)–X-Chem, Inc. (X-Chem), a privately held biotechnology company applying its innovative drug discovery platform to the generation of novel small molecule therapeutics, today announced a collaboration with Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX). Under the terms of the agreement, X-Chem will apply its proprietary DEXTM libraries, which contain more than …

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Intellia Announces Progress with CRISPR Technology at the ASGCT Annual Meeting

WASHINGTON, May 13, 2017 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on the development of potentially curative therapeutics using CRISPR technology, presented an update on its long-term mouse genome editing and delivery studies and shared new, first-time data in rat models demonstrating consistent dose-dependent …

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Veracyte Announces Next-Generation Afirma Test Can Help More Patients Avoid Unnecessary Surgery in Thyroid Cancer Diagnosis

SOUTH SAN FRANCISCO, Calif., May 4, 2017 /PRNewswire/ — Veracyte, Inc. (NASDAQ: VCYT), a genomic diagnostics company focused on reducing unnecessary surgeries and healthcare costs by resolving diagnostic uncertainty, today announced data from a pivotal clinical validation study of its Afirma Genomic Sequencing Classifier (GSC). The data suggest that the …

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Bluebird Bio Licenses Delivery Technology to Novartis for Development of CAR-T Therapies

CAMBRIDGE, Mass.–(BUSINESS WIRE)–bluebird bio, Inc. (Nasdaq: BLUE) today announced that it has entered into a worldwide license agreement around its proprietary lentiviral vector platform with Novartis Pharma AG. “bluebird bio is a pioneer in the field of lentiviral vector-based cell and gene therapy, and our partnerships and licensing agreements have …

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New Imaging Method May Predict Immunotherapy Response Early

Bottom Line: A noninvasive PET imaging method that measures granzyme B, a protein released by immune cells to kill cancer cells, was able to distinguish mouse and human tumors that responded to immune checkpoint inhibitors from those that did not respond early in the course of treatment. Journal in Which …

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