Basel, 5 November 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data for its approved and investigational medicines will be presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition from 5 – 8 December 2020. Eleven Roche medicines will be featured in more than 80 abstracts,... Read more
Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows Thermo Fisher and the Biopharmaceutical Analysis Training Laboratory (BATL) of Northeastern University aim to deliver cutting-edge analytical solutions and training programs SAN JOSE, Calif., Nov. 4, 2020 /PRNewswire/ — Thermo Fisher Scientific, the world leader in serving science, and the Biopharmaceutical... Read more
Latest testing strategy to increase the sample processing efficiency WALTHAM, Mass. –(BUSINESS WIRE)–Oct. 29, 2020– PerkinElmer, Inc. (NYSE: PKI) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) to allow sample pooling with PerkinElmer Read more
(CHICAGO – October 22, 2020) GE Healthcare today announced its largest ever ultrasound deal in the United States – an $11 million order by St. Luke’s University Health Network to install GE Healthcare ultrasound technology and IT workflow solutions system-wide. GE Healthcare will continue upgrades over the next four years to maintain latest technology for... Read more
Approval supported by data from phase III confirmatory trials, VIALE-A and VIALE-C VIALE-A study showed Venclexta plus azacitidine significantly improved overall survival in newly diagnosed AML compared to azacitidine alone Supplemental New Drug Applications approved under the FDA’s Real-Time Oncology Review pilot programme and Project Orbis initiative Basel, 19 October 2020 – Roche (SIX: RO,... Read more
Chicago (October 12, 2020) – GE Healthcare today announced U.S. FDA 510k clearance for its Ultra Edition package on Vivid[1] cardiovascular ultrasound systems, which includes new features based on artificial intelligence (AI) that enable clinicians to acquire faster, more repeatable exams consistently. Methodical assessments of heart function are key in echocardiography but can be tedious... Read more
FRANKLIN LAKES, N.J., Oct. 5, 2020 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD FACSLyric™ Flow Cytometer with the Integrated BD FACSDuet™ Sample Preparation System. The new integrated system enables clinical laboratories to fully automate... Read more
Next-generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly 100 percent preventable with proper screening, vaccination and treatment New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs More... Read more
US FDA approves +PLUSPAK™ (polymer bottle) Pharmacy Bulk Package for the gadolinium-based contrast agent, Clariscan™ (gadoterate meglumine) As the only polymer bottle for an MRI contrast agent, Clariscan in +PLUSPAK offers the potential for increased workplace safety, efficiency, convenience and environmental advantages Clariscan has been approved in more than 65 countries globally, with more than... Read more
FDA Approves First NGS-Based Companion Diagnostic for RET Fusion-Positive Non-Small Cell Lung Cancer CDx approval expands clinical utility of Oncomine Dx Target Test to identify candidates for GAVRETO CARLSBAD, Calif., Sept. 8, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a... Read more