November 26, 2018 Clinical Research/Diagn. M&A, Partnerships

Cobra Biologics, Pall Corporation and the Cell and Gene Therapy Catapult Win £1.5M Innovate UK Grant to Investigate Continuous Manufacturing for Gene Therapies

KEELE, England, PORT WASHINGTON, N.Y. and LONDON, Nov. 26, 2018 /PRNewswire/ — Cobra Biologics, an international contract development and manufacturing organization (CDMO) with a focus on advanced therapy medicinal products (ATMPs) has won a £1.5M shared grant from Innovate UK, the United Kingdom’s innovation agency. Co-winners, Pall Corporation, a global leader in filtration, separation and purification, and the Cell and Gene Therapy Catapult, an independent research and technology organization... Read more

November 19, 2018 Bio/Pharma/CRO Clinical Research/Diagn. Informatics & Software Product Launch

Lonza Opens Collaborative Innovation Center in Haifa, Israel

November 19,2018 Product News PDF New center will be a hub to identify and accelerate fresh solutions to rethink drug development and manufacturing Labs in the new facility, together with funding, will enable projects in collaboration with Israeli talent in academia, medical institutions and early-stage innovative companies Haifa (IL), 19 November 2018 – Lonza Pharma &... Read more

November 19, 2018 Clinical Research/Diagn. PR/Corporate

Two Pore Guys Receives $2.8M Grant to Develop Sensitive, Low-Cost Molecular Diagnostic Tests for Tuberculosis

Goal of Bill & Melinda Gates Foundation Grant Is to Improve TB Care in Resource-Poor Settings SANTA CRUZ, Calif.–(BUSINESS WIRE)–Two Pore Guys, Inc. (2PG) today announced that the company has received a $2.8 million grant from the Bill & Melinda Gates Foundation to develop sensitive, low-cost molecular diagnostic tests for tuberculosis (TB) using its solid-state nanopore technology.... Read more

November 19, 2018 Clinical Research/Diagn. M&A, Partnerships

Arrayit Corporation Announces Allergy Testing Agreement with Sutter Health

Sunnyvale, Nov. 05, 2018 (GLOBE NEWSWIRE) — Arrayit Corporation (OTC: ARYC), a life sciences and personalized medicine company, announces an allergy testing agreement with Northern California healthcare leader Sutter Health. The company is providing its proprietary microarray-based finger stick allergy testing services to Sutter Health via doctors in the Sutter Health-affiliated Palo Alto Medical Foundation. Sutter Health,... Read more

November 15, 2018 Clinical Research/Diagn. Licensing, IP, and Legal Liq. Handling & Robotics

Dynex Technologies Receives CFDA Approval to Supply AGILITY Automated ELISA Processing System to China

Company’s portfolio approval demonstrates dedication to clinical labs in the Asia-Pacific region November 15, 2018 08:14 AM Pacific Standard Time CHANTILLY, Va.–(BUSINESS WIRE)–Dynex® Technologies, Inc., announced today that it received Chinese Food and Drug Administration (CFDA) approval to market its DYNEX AGILITY® instrument and software for quantitative immunoassay measurements of analytes, including proteins and microbiological specimens. “With... Read more

November 13, 2018 Clinical Research/Diagn. Product Launch

bioMérieux launches the BIOFIRE® FILMARRAY® Pneumonia Panels with FDA clearance and CE Marking

13 November, 2018 bioMérieux, a world leader in the field of in vitro diagnostics, today announced the Food and Drug Administration (FDA) 510(k) clearance of the BIOFIRE® FILMARRAY® Pneumonia Panel and the CE-Mark of the BIOFIRE® FILMARRAY® Pneumonia Panel plus. The BIOFIRE®  FILMARRAY®Pneumonia Panels aid in the diagnosis of lower respiratory tract infections. bioMérieux’s molecular biology affiliate, BioFire Diagnostics, builds upon its... Read more

November 13, 2018 Clinical Research/Diagn. Product Launch

New Diagnostic Test Helps Hospitals More Quickly Identify and Treat Emerging Antibiotic-Resistant Bacteria

Fully-automated BD Phoenix™ CPO Detect Test Receives U.S. FDA Clearance FRANKLIN LAKES, N.J., Nov. 13, 2018 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration 510(k) clearance of the BD Phoenix™ CPO detect test, which will allow hospitals to identify infections caused by carbapenemase-producing organisms (CPOs). The... Read more

November 13, 2018 Clinical Research/Diagn. Product Launch

New Diagnostic Test Helps Hospitals More Quickly Identify and Treat Emerging Antibiotic-Resistant Bacteria

FRANKLIN LAKES, N.J., Nov. 13, 2018 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration 510(k) clearance of the BD Phoenix™ CPO detect test, which will allow hospitals to identify infections caused by carbapenemase-producing organisms (CPOs). The test may help hospitals contain the... Read more

November 9, 2018 Clinical Research/Diagn. M&A, Partnerships

bioMérieux acquires a majority stake in Hybiome and strengthens its presence both in China and in the immunoassay market

09 November, 2018 bioMérieux, a world leader in the field of in vitro diagnostics, today announces the acquisition of a majority holding in Suzhou Hybiome Biomedical Engineering Co.Ltd. This announcement follows the acquisition of a minority stake in July 2018. Founded in 2009 and based in Suzhou (China), Hybiome is specialized in automated immunoassay tests. The... Read more

November 7, 2018 Clinical Research/Diagn.

BD Announces Clinical Trial Data for the LUTONIX® 014 Drug-Coated Balloon Below-The-Knee IDE Trial

FRANKLIN LAKES, N.J., Nov. 7, 2018 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the safety and efficacy data from the LUTONIX® Drug-Coated Balloon (DCB) IDE, level 1 clinical trial for a below-the-knee (BTK) indication. The clinical study is a prospective, global, multicenter, randomized, controlled trial comparing... Read more