Collaborations, Competitor News, Data Partnership, Oncology

xCures announces real world biomarker study for patients with FGFR-mutant bladder cancer receiving Balversa®

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Tyra Biosciences supported study investigates if non-invasive blood and urine samples provide biomarkers to assess clinical response to erdafitinib treatment OAKLAND, CALIFORNIA, UNITED STATES, March 10, 2022 /EINPresswire.com/ — Today, xCures announced their collaboration with Tyra Biosciences for a real-world biomarker study involving patients with FGFR-mutant bladder cancer receiving Balversa® (erdafitinib)…

Academic, Collaborations, Competitor News, Data Partnership

C-Path and Tufts Medical Center Collaborate on EHR Data Transfer

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TUCSON, Ariz., March 10, 2022 — Critical Path Institute (C-Path) and Tufts Medical Center have announced a collaboration to transfer electronic healthcare records (EHR) data to C-Path as part of the real-world data (RWD) effort to generate actionable real-world evidence (RWE) for neonatal drug development. This initiative, funded by a grant from the U.S….

Government/Regulatory, Industry News

What New FDA Guidance Means for the Future of Real World Data Use

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Matthew W. Reynolds, Vice President, Real World Solutions, IQVIA 03.09.22Recent  FDA guidance on using real world data (RWD) to study the safety and effectiveness of products and treatments represents an exciting advancement for clinical research. Opportunities for RWD usage have existed for many years now and has grown more rapidly during the pandemic,…

Competitor News, Government/Regulatory

RWE Alliance Submits Comments on All Four Recent FDA RWE Guidances, Looks Toward Further Engagement to Advance Use of RWE to Benefit Patients

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March 09, 2022 04:15 PM Eastern Standard Time WASHINGTON–(BUSINESS WIRE)–Today, the RWE Alliance submitted a substantial comment letter in response to the U.S. Food and Drug Administration’s (FDA) recent draft guidance, “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.”…

Collaborations, Data Partnership, Partner and Collaborator News, Pharma, RWE Study

AAAAI 2022: Real-World Analysis Confirms Benefits of Benralizumab for Severe Eosinophilic Asthma

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February 26, 2022—Phoenix, Arizona—Use of benralizumab in patients aged 12 and over with severe eosinophilic asthma results in significant reduction in asthma exacerbations, oral corticosteroid use, and healthcare resources utilization, according to a real-world analysis presented at the American Academy of Allergy, Asthma, & Immunology Annual Meeting, which took place…

China, Industry News, International, RWE Study

Comparative Effectiveness of Abiraterone and Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer in Taiwan

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Background: Abiraterone and enzalutamide are widely used as first-line treatment for metastatic castration-resistant prostate cancer (mCRPC); however, their efficacy in mCRPC has been inconsistently demonstrated in other outcome studies from real-world databases. The aim of our study was to assess the comparative effectiveness of abiraterone and enzalutamide in patients with mCRPC…

AI, Competitor News, Ethics, Product Updates

ViVE 2022: Google Health expands AI capabilities of Care Studio to organize patient data

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MIAMI—Google Health is expanding the capabilities of its clinician-facing search tool using artificial intelligence to bring context to physicians’ clinical notes. Speaking at the ViVE 2022 conference, Paul Muret, vice president and general manager of Care Studio at Google Health, announced new features of the company’s clinical software that harmonizes healthcare data from…

Industry News

ISPOR Launches “About Real-World Evidence” Content

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Newswise — Lawrenceville, NJ, USA—March 8, 2022—ISPOR—The Professional Society for Health Economics and Outcomes Research (HEOR) in partnership with the Bristol Myers Squibb-Pfizer Alliance announced that it has launched a new “About Real-World Evidence” microsite. This introductory content is designed for the broader healthcare audience toward the goal of engaging…

Collaborations, Competitor News, Data Partnership

TARGET-IBD Study Reveals Nearly a Third of Patients with Inflammatory Bowel Disease Did Not Undergo Objective Assessment Prior to Biologic Dose Change, Discontinuation

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DURHAM, N.C., March 8, 2022 /PRNewswire/ — A new TARGET-IBD study analysis shows one-third of patients with inflammatory bowel disease (IBD) did not have a record of objective disease activity assessment or therapeutic drug monitoring (TDM) prior to a biologic therapy dose change or discontinuation. The study was conducted by Target RWE, a leading…