Technology & Devices

Guardant Health and Radius Health Partner to Develop Liquid Biopsy Companion Diagnostic for Elacestrant

REDWOOD CITY, Calif., July 30, 2020 (GLOBE NEWSWIRE) — Guardant Health, Inc. (Nasdaq: GH) today announced a strategic collaboration with Radius Health, Inc. (Radius, Nasdaq: RDUS) to pursue regulatory approval of the Guardant360® CDx as a companion diagnostic for elacestrant (RAD1901), an investigational selective estrogen receptor degrader (SERD) being studied in the treatment …

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FDA Approves Roche’s Ventana HER2 Dual ISH Test as a Companion Diagnostic to Identify Breast Cancer Patients Eligible for Targeted Therapy

Basel, 29 July 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast cancer and as a companion diagnostic for Herceptin (trastuzumab) therapy. …

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BD receives FDA Approval for HPV Test with Extended Genotyping Capabilities

FRANKLIN LAKES, N.J., July 22, 2020 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it received approval for a pre-market approval (PMA) supplement from the U.S. Food and Drug Administration (FDA) for an expanded version of its BD Onclarity™ HPV …

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GSK and CureVac Announce Strategic mRNA Technology Collaboration

GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac today announced the signing of a strategic collaboration agreement for the research, development, manufacturing and commercialization of up to five mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. The collaboration complements GSK’s existing mRNA capabilities with CureVac’s integrated mRNA platform. mRNA (messenger …

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Orchard Therapeutics Announces Global License Agreements for Stable Cell Line Technology from GSK

BOSTON and LONDON, July 15, 2020 (GLOBE NEWSWIRE) — Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company has entered into two worldwide royalty-bearing license agreements with GlaxoSmithKline plc (GSK) (LSE/NYSE: GSK) for use of their proprietary lentiviral stable cell line technology (LV-SCLT) for Orchard’s …

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Medtronic to Acquire Medicrea and its Spinal Surgery Technology

DUBLIN & LYON, France–(BUSINESS WIRE)–Medtronic plc (NYSE:MDT), a global leader in medical technology, and Medicrea (Euronext Growth Paris: FR0004178572 – ALMED Medicrea; OTCQX Best Market – MRNTF), a pioneer in the transformation of spinal surgery through artificial intelligence, predictive modeling and patient specific implants, today announced that they have entered …

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Illumina Launches TruSight Software Suite to Accelerate the Identification of Genetic Diseases

SAN DIEGO–(BUSINESS WIRE)– Illumina, Inc. (NASDAQ: ILMN) is bringing turn-key data analysis solutions to accelerate and facilitate the adoption of whole-genome sequencing with the launch of the TruSight™ Software Suite. TruSight Software delivers ready-made infrastructure to realize the full potential of whole-genome sequencing for rare genetic diseases. This new offering enables sample-to-report analysis …

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Thermo Fisher Scientific Signs Companion Diagnostic Agreement with Chugai Pharmaceutical

CARLSBAD, Calif., July 8, 2020 /PRNewswire/ — Thermo Fisher Scientific has signed a companion diagnostic (CDx) agreement with Chugai Pharmaceutical Co., Ltd., a member of the Roche Group, and has applied to the Ministry of Health, Labour and Welfare (MHLW) to expand the use of the Oncomine Dx Target Test …

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CENTOGENE Receives FDA Emergency Use Authorization for COVID-19 Molecular Diagnostic Test

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, July 02, 2020 (GLOBE NEWSWIRE) — Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, today announced that the U.S. Food and Drug Administration (FDA) …

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Carmine Therapeutics and Takeda Collaborate to Develop Rare Disease Gene Therapies Using Novel Red Blood Cell Extracellular Vesicles Platform

CAMBRIDGE, Mass., June 30, 2020 /PRNewswire/ — Carmine Therapeutics announced today that it has signed a research collaboration agreement with Takeda Pharmaceutical Company Limited (“Takeda”) to discover, develop and commercialize transformative non-viral gene therapies for two rare disease targets using Carmine’s REGENT(TM) technology, based on red blood cell extracellular vesicles. …

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