May 16, 2019 Acad, Gov/Utilities Bio/Pharma/CRO

Roche announces FDA approval for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukaemia

Basel, 16 May 2019 Roche announces FDA approval for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukaemia Fixed 12-month treatment with Venclexta plus Gazyva significantly reduced risk of disease progression or death by 67% compared to a current standard-of-care Approval for expanded use of Venclexta offers more adults with chronic lymphocytic leukaemia... Read more

May 15, 2019 Acad, Gov/Utilities Clinical Research/Diagn. Lab Top-10 Product Launch

New Study Demonstrates Clinical Utility of Liquid Biopsy for Cancer Monitoring

Multi-institutional clinical research indicates liquid biopsy can detect changes in tumor profile and resistance to treatment CARLSBAD, Calif., May 15, 2019 /PRNewswire/ — Growing scientific evidence supports liquid biopsy as a valuable tool for monitoring treatment response in patients with cancer. A new retrospective clinical research study showing comparable results between liquid and tissue biopsy in... Read more

May 6, 2019 Acad, Gov/Utilities

FDA approves Roche’s Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment

Basel, 06 May 2019 FDA approves Roche’s Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment The approval is based on data showing Kadcyla cut the risk of disease recurring by half compared to Herceptin in the adjuvant setting for specific patients with HER2-positive early breast... Read more

April 30, 2019 Acad, Gov/Utilities Bio/Pharma/CRO PR/Corporate

BD Receives FDA Approval for Fully Sterile Chlorhexidine Gluconate Antiseptic Skin Preparation

FRANKLIN LAKES, N.J., April 30, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) approval for BD ChloraPrep™ skin preparation with sterile solution, the only fully sterile chlorhexidine gluconate (CHG) antiseptic skin preparation commercially available in the... Read more

April 23, 2019 Acad, Gov/Utilities Clinical Research/Diagn. Product Launch

Roche launches new VENTANA HER2 Dual ISH companion diagnostic test for breast and gastric cancer patients eligible for targeted therapy

Basel, 23 April 2019 Roche launches new VENTANA HER2 Dual ISH companion diagnostic test for breast and gastric cancer patients eligible for targeted therapy Nearly 2.1 million new cases of breast cancer are diagnosed worldwide each year, and more than 620,000 people will die from the disease.1 About 15 to 20 percent of women diagnosed... Read more

April 17, 2019 Acad, Gov/Utilities Bio/Pharma/CRO Chromatography Clinical Research/Diagn. Lab Top-10 PR/Corporate

Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC

Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC PD-L1 IHC 22C3 pharmDx Can Now Be Used to Identify a Broader Range of NSCLC Patients for First-line Treatment With KEYTRUDA® (pembrolizumab) SANTA CLARA, Calif., April 16, 2019 Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has... Read more

April 16, 2019 Acad, Gov/Utilities Clinical Research/Diagn. Lab Top-10 M&A, Partnerships Mass Spectrometry

Bruker and the Translational Metabolic Laboratory at Radboud University Medical Center Announce the Establishment of a Joint Center of Excellence for Translational Omics

Nijmegen, Netherlands, April 16, 2019 – At the opening event of the Netherlands X-omics Initiative, Bruker and the Translation Metabolic Laboratory (TML) at Radboud University Medical Center (UMC) today jointly announce the establishment of a Center of Excellence (CoE) for Translational Omics. Under the leadership of Professor Alain van Gool, the joint CoE will focus on... Read more

April 15, 2019 Acad, Gov/Utilities

GE Healthcare Accelerates AI Model Development and Deployment with Launch of Edison Integration to American College of Radiology AI-LAB™

Boston, MA – April 8, 2019 – GE Healthcare today announced Edison will integrate with ACR AI-LAB. The Edison platform helps accelerate the development and adoption of Artificial Intelligence (AI) technology and empower providers to deliver faster, more precise care. Edison serves as a “digital thread” for GE Healthcare’s existing AI partnerships and products, and... Read more

April 12, 2019 Acad, Gov/Utilities Clinical Research/Diagn. Product Launch

QIAGEN launches first FDA-approved companion diagnostic using FGFR alterations to help guide the treatment of metastatic urothelial cancer

Germantown, Maryland, and Hilden, Germany, April 12 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. launch of its novel therascreen® FGFR RGQ RT-PCR Kit (therascreen FGFR Kit) as a companion diagnostic to help guide the use of the newly approved FGFR kinase inhibitor, BALVERSA™ (erdafitinib), developed by Janssen Biotech,... Read more