June 11, 2019 Acad, Gov/Utilities

FDA grants Roche’s Polivy accelerated approval for people with previously treated aggressive lymphoma

Basel, 11 June 2019 FDA grants Roche’s Polivy accelerated approval for people with previously treated aggressive lymphoma New targeted medicine shown to improve clinical outcomes in people with relapsed or refractory diffuse large B-cell lymphoma compared to a commonly used regimen First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of... Read more

June 10, 2019 Acad, Gov/Utilities PR/Corporate Product Launch

Xylem’s new ‘Decision Intelligence’ paper presents six comprehensive strategies to transform the economics of utility water management

New Xylem publication discusses how decision intelligence enables utilities to secure a sustainable, resilient and affordable water future DENVER–(BUSINESS WIRE)–Jun. 10, 2019– As global water challenges intensify, new approaches are needed to create a step change improvement in water system performance. Today at ACE19, global water technology company, Xylem (NYSE: XYL) unveiled a new publication... Read more

June 5, 2019 Acad, Gov/Utilities PR/Corporate Product Launch

Fernando Vergas appointed new Vice President of WITec Instruments Corporation

WITec GmbH, leading manufacturer of Raman and scanning-probe microscopes, has named Dr. Fernando Vargas as Vice President of WITec Instruments Corporation, its USA-based subsidiary, and Area Manager of the USA market. As a longtime WITec team member with a background in physics, Vargas has extensive experience in both the scientific application and strategic sales of... Read more

May 24, 2019 Acad, Gov/Utilities Clinical Research/Diagn. Product Launch

QIAGEN launches first FDA-approved companion diagnostic for PIK3CA biomarkers to enhance precision medicine in breast cancer

Germantown, Maryland, and Hilden, Germany, May 24, 2019 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the immediate launch of its therascreen® PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with PIQRAY (alpelisib), a... Read more

May 20, 2019 Acad, Gov/Utilities Liq. Handling & Robotics Microscopy Product Launch

QIAGEN gains 510(k) clearance by FDA for QIAstat-Dx in the U.S. and launches system as next generation platform for syndromic insights

Germantown, Maryland, and Hilden, Germany, May 20, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. launch of its QIAstat-Dx syndromic testing system after receiving 510(k) clearance by the U.S. Food and Drug Administration, along with the multiplex QIAstat-Dx® Respiratory Panel for simultaneous qualitative detection and identification of multiple respiratory... Read more

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