March 4, 2020 Acad, Gov/Utilities Atomic Spectroscopy

FDA grants Breakthrough Device Designation for Roche's Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma

The Elecsys GALAD score aims to support clinicians in diagnosing hepatocellular carcinoma by giving them more timely and accurate information to make earlier interventions When hepatocellular carcinoma is detected and managed at the very earliest, patient’s 5-year survival rates can increase to over 70%1 Utilizing blood-based biomarkers, as part of the Elecsys GALAD score, is... Read more

February 25, 2020 Acad, Gov/Utilities

FDA accepts Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer

Fixed-dose combination administered under the skin in just minutes, compared to hours with intravenous administration, significantly reducing time spent receiving treatment US Food Drug and Administration is expected to decide on approval by 18 October 2020 Basel, 25 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug... Read more

February 24, 2020 Acad, Gov/Utilities Lab Top-10 Liq. Handling & Robotics PAI Top-10

Luminex Corporation Submits VERIGENE® II Respiratory Flex Assay for FDA Clearance

AUSTIN, Texas, Feb. 24, 2020 /PRNewswire/ — Luminex Corporation (NASDAQ: LMNX) today announced that the company has submitted an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of the VERIGENE® II Respiratory Flex Assay, the second VERIGENE II assay to be submitted to the agency. The VERIGENE® II Respiratory Flex (RSP Flex) Assay... Read more

February 19, 2020 Acad, Gov/Utilities

FDA grants priority review to Roche’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer

Basel, 19 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without... Read more

February 11, 2020 Acad, Gov/Utilities M&A, Partnerships PAI Top-10

MTS Partners With Auburn University To Advance Additive Manufacturing

EDEN PRAIRIE, Minn., Feb. 11, 2020 /PRNewswire/ — MTS Systems Corporation (NASDAQ: MTSC), a leading global supplier of high-performance test systems, motion simulators and sensors, today announced a strategic alliance with Auburn University to accelerate additive manufacturing research and test development. Auburn University is home to the National Center for Additive Manufacturing Excellence (NCAME), which is... Read more

February 6, 2020 Acad, Gov/Utilities Environ, Ag./Food & Bev

Dr. Scott Gottlieb, former US FDA Commissioner, joins Illumina’s Board of Directors

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) announced today that Scott Gottlieb, M.D. has joined the company’s Board of Directors, effective February 4, 2020. Dr. Gottlieb is currently a special partner at the venture capital firm New Enterprise Associates (NEA) and a resident fellow at the American Enterprise Institute (AEI). From 2017 to 2019, he served... Read more

January 27, 2020 Acad, Gov/Utilities

Roche submits supplemental Biologics License Application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer

Basel, 27 January 2020 Application is being reviewed under FDA’s Real-Time Oncology Review pilot programme Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), for the treatment of people with... Read more

January 16, 2020 Acad, Gov/Utilities Atomic Spectroscopy Lab Top-10 M&A, Partnerships

Agilent Collaborates with University Researchers Investigating Risk Factors for Eczema

Agilent Collaborates with University Researchers Investigating Risk Factors for Eczema SANTA CLARA, Calif. , January 16, 2020 Agilent Technologies Inc. (NYSE: A) is collaborating with researchers at two UK universities who are looking into the risk factors for atopic eczema (also known as atopic dermatitis), a chronic skin condition that affects one in five children... Read more

December 13, 2019 Acad, Gov/Utilities Lab Top-10 Product Launch

PerkinElmer Launches First FDA-Approved Assay Kit to Screen for Duchenne Muscular Dystrophy in Newborns

Available on PerkinElmer’s automated GSP® instrument, kit supports early diagnosis by measuring CK-MM concentration instead of CK enzyme activity WALTHAM, Mass.–(BUSINESS WIRE)–Dec. 13, 2019– PerkinElmer, Inc., (NYSE: PKI), a global leader committed to innovating for a healthier world, today announced that its GSP® Neonatal Creatine Kinase –MM (CK-MM) kit has received U.S. Food & Drug... Read more

December 5, 2019 Acad, Gov/Utilities Clinical Research/Diagn. Lab Top-10

Thermo Fisher Scientific to Bring One-Day Genomic Profiling to Hematology Oncology

Thermo Fisher Scientific to Bring One-Day Genomic Profiling to Hematology Oncology Comprehensive myeloid assay available in 2020 to run on the Ion Torrent Genexus System CARLSBAD, Calif., Dec. 5, 2019 /PRNewswire/ — Clinical researchers who take a traditional sequential approach to analyze myeloid malignancies, a highly heterogeneous group of disorders, face a major hurdle: a... Read more