Competitor News, Oncology, Product Updates

U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for KEYTRUDA® (pembrolizumab) to Identify Patients with Microsatellite Instability-High (MSI-H) Solid Tumors

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Foundation Medicine’s tissue-based comprehensive genomic profiling test is now the first and only FDA-approved companion diagnostic to aid in identifying patients with MSI-H solid tumors who may benefit from immunotherapy February 21, 2022 06:57 AM Eastern Standard Time CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. today announced that it received approval from the…

Clinical Trials, Collaborations, Partner and Collaborator News

Unlearn Signs Multi-Year Collaboration with Merck KGaA, Darmstadt, Germany to Accelerate Immunology Trials using Twintelligent RCTs™

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Collaborators will leverage AI-generated Digital Twins to enable smaller, more efficient pivotal clinical trials. February 16, 2022 07:30 AM Eastern Standard Time SAN FRANCISCO–(BUSINESS WIRE)–Unlearn®, developer of the Twintelligent RCT™, today announced that the company has entered into a multi-year collaboration with Merck KGaA, Darmstadt, Germany to accelerate late-stage clinical trials with…

Collaborations, Competitor News, Data Partnership

Calyx EDC Selected for RWE Data Collection in Lengthy, Late Phase Trial

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Leading pharmaceutical company trusts Calyx to meet accelerated timelines and support multi-year trials NEWS PROVIDED BYCalyx  Feb 21, 2022, 07:55 ET NOTTINGHAM, England and MORRISVILLE, N.C., Feb. 21, 2022 /PRNewswire/ — Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced its electronic…

Collaborations, Competitor News

Walmart and Quest Diagnostics Empower People to Take Control of Their Healthcare Through New Consumer-Initiated Laboratory Testing Solution Powered by QuestDirect™ Through Walmart.com

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Convenient, physician-guided medical insights help people manage health without a trip to the doctor’s office More than 50 tests available (at home & patient service center collection options) for conditions ranging from COVID-19 and heart health to sexually transmitted diseases with opportunity for prescription drug treatment, when appropriate Builds upon…

Collaborations, Competitor News, International, Japan, Oncology, Product Updates

BC Platforms Adds Japan’s Mitsubishi Space Software to its Global Data Network

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ZURICH, Feb. 21, 2022 /PRNewswire/ — BC Platforms (BCP), a global leader in healthcare data management and analytics, today announced a new data partnership with Japan’s Mitsubishi Space Software Co. Ltd. (Mitsubishi), one of the country’s oldest bioinformatics companies. The collaboration, which provides secure access to Mitsubishi’s cancer specific cohort of 8,000 patients, will accelerate the…

Collaborations, Competitor News, Data Partnership, RWE Study

Disparities in economic burden for children with leukemia insured by resident basic medical insurance: evidence from real-world data 2015–2019 in Guangdong, China

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Background Pediatric leukemia is the most prevalent childhood cancer in China and incurs heavy economic burden to patients without sufficient insurance protection. Although all Chinese children are obliged to enroll in the national insurance scheme, “Resident Basic Medical Insurance (RBMI)”, the protection may vary among patient subgroups. This study is…

Academic, Partner and Collaborator News

UC-Irvine Institute for Precision Health Called an ‘Ecosystem for Collaboration’

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The University of California, Irvine has launched the Institute for Precision Health (IPH), which brings together UCI’s health sciences, engineering, machine learning, artificial intelligence, clinical genomics and data science capabilities. UCI said the institute would bring a multifaceted, integrated approach to precision medicine, which collects patient data – history, exams,…

Collaborations, Competitor News, Data Partnership

The Myrovlytis Trust Leverages Pulse Infoframe’s Platform to Study Birt-Hogg-Dubé Syndrome

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LONDON, ON, Feb. 17, 2022 /PRNewswire/ — The Myrovlytis Trust is creating a patient registry for Birt-Hogg-Dubé Syndrome (BHD) to better understand the epidemiology of the disease, its prevalence, and the disease trajectory, to improve the quality of life for this community, and to ultimately develop treatments for BHD. Six hundred families…

Government/Regulatory, Industry News

Real-World Evidence: US FDA Urged To Leverage Prior Validation Work and Regulatory Experience

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Executive Summary In comments on FDA guidance on electronic health records and medical claims, Duke-Margolis Center suggests a certification process for validated datasets, while data companies request the agency do more to publicize the experience to date with RWE in regulatory submissions.Source: AlamyTHERE IS A DESIRE NOT TO HAVE TO…