Technology & Devices

FDA Issues Emergency Use Authorization to Yale School of Public Health for its SalivaDirect COVID-19 Diagnostic Test

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection. “The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another …

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Galapagos Partners with Scipher Medicine to to Identify Novel Drug Targets for Treatment of Inflammatory Bowel Disease

Mechelen, Belgium and Boston, USA; 12 August 2020 – Galapagos NV (Euronext & Nasdaq: GLPG) and Scipher Medicine (Scipher), a Boston based privately held precision medicine company focused on autoimmune diseases, today announce a collaboration to advance novel drug targets identified by Scipher for the treatment of inflammatory bowel disease …

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Medtronic to Acquire Smart Insulin Pen Company Companion Medical

DUBLIN and SAN DIEGO, Aug. 11, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the planned acquisition of privately-held Companion Medical, manufacturer of InPen — the only U.S. FDA-cleared smart insulin pen system paired with an integrated diabetes management app on the market. The …

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Ligand to Acquire Pfenex for up to $516 Million

SAN DIEGO–(BUSINESS WIRE)–Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) and Pfenex Inc. (NYSE American: PFNX) today announced the signing of a definitive agreement for Ligand to acquire all outstanding shares of Pfenex for $12.00 per share in cash or $438 million in equity value on a fully diluted basis. In addition, Ligand will …

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Thermo Fisher Scientific Develops COVID-19 Antibody Assay Targeting Transplant Community

WEST HILLS, Calif., Aug. 10, 2020 /PRNewswire/ — Thermo Fisher Scientific continues to expand its response to the COVID-19 pandemic, developing a new serological assay targeted towards transplant candidates and recipients that can detect antibodies directed against COVID-19 (SARS-CoV-2). The assay will be provided under the company’s One Lambda brand …

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Guardant Health Guardant360 CDx First FDA-Approved Liquid Biopsy for Comprehensive Tumor Mutation Profiling Across All Solid Cancers

REDWOOD CITY, Calif., Aug. 07, 2020 (GLOBE NEWSWIRE) — Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor). The Guardant360 CDx is also …

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FDA Expands Approval of Adaptive’s clonoSEQ Assay to Assess Minimal Residual Disease in Patients with Chronic Lymphocytic Leukemia

SEATTLE, Aug. 06, 2020 (GLOBE NEWSWIRE) — Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today received clearance from the U.S. Food and Drug Administration (FDA) for its clonoSEQ® Assay …

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Biogen and Denali to Collaborate on LRRK2 Program for Parkinson’s Disease and Certain TV Platform-Enabled Programs for Neurodegenerative Diseases

CAMBRIDGE, Mass. and SOUTH SAN FRANCISCO, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) and Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that they have signed a binding agreement to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease. Biogen will also …

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RadNet and Hologic Collaborate to Advance the Development of Artificial Intelligence Tools in Breast Health

LOS ANGELES and MARLBOROUGH, Mass., Aug. 06, 2020 (GLOBE NEWSWIRE) — RadNet, Inc. (Nasdaq: RDNT), a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services, and Hologic, Inc. (Nasdaq: HOLX), an innovative medical technology company primarily focused on improving women’s health, have entered into a definitive collaboration to …

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Genfit Announces Pivotal Publication of NIS4 Technology to Identify Patients with At-Risk NASH in The Lancet Gastroenterology & Hepatology

Lille (France), Cambridge (Massachusetts, United States), August 05, 2020 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, today announced that pivotal data describing the derivation and validation of NIS4™ has been accepted for publication by The Lancet …

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