Diagnostics

Hologic’s 3Dimensions™ System for 3D Mammography Receives EUREF Type Test Certification

11/08/2022

3Dimensions System Earns Distinction for Meeting or Exceeding Rigorous European Image Quality and Dose Standards Excerpt from the Press Release: MARLBOROUGH, Mass.–(BUSINESS WIRE)–Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, announced today that its 3Dimensions™ mammography system was awarded EUREF Type Test certification by the European Reference Organisation for Quality Assured Breast Screening…

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Mirum Pharmaceuticals Presents Long-Term LIVMARLI® (maralixibat) Data and New Alagille Syndrome Caregiver Burden Analysis at NASPGHAN 2022 Annual Meeting

10/21/2022

– Six-year natural history comparison with maralixibat demonstrates event-free and transplant-free survival in patients with Alagille syndrome (ALGS) – Characterization of four-year growth improvement in Alagille syndrome with maralixibat – New analysis evaluating health-related quality of life impact assessed on caregivers of children with Alagille syndrome – Mirum to host a scientific symposium on the…

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Axcella Announces Positive Interim Data from Phase 2b EMMPACT Study of AXA1125 in Nonalcoholic Steatohepatitis (NASH)

10/07/2022

Subjects enrolled with biopsy confirmed NASH experienced clinically and statistically significant improvements in liver stiffness as measured by FibroScan, a non-invasive measure of liver fibrosis Subjects with NASH experienced clinically and statistically significant improvements in alanine aminotransferase (ALT), a measure of liver cell inflammation, at both dose levels of AXA1125 Findings demonstrate improvement in hepatic…

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ImmunoGen Presents Comprehensive Updates for Mirvetuximab Soravtansine Combination Data in Ovarian Cancer at IGCS

10/07/2022

Mirvetuximab Plus Bevacizumab Demonstrated Meaningful Efficacy in Recurrent FRα-Positive Ovarian Cancer Across a Broad Range of FRα Expression Regardless of Prior Treatment; Data to be Highlighted in Oral Presentation Additional Clinical Benefit Outcomes from Pivotal SORAYA Study Also Reported Excerpt from the Press Release: WALTHAM, Mass.–(BUSINESS WIRE)–ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding…

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The New England Journal of Medicine Publishes Pivotal Tofersen Data that Show Benefits in Rare, Genetic Form of ALS

10/03/2022

Publication includes the Phase 3 VALOR SOD1-ALS trial and its open-label-extension study, underscoring the importance of these longer-term data 12-month data show earlier initiation of tofersen slowed decline across critical measures of function and strength in people diagnosed with SOD1-ALS Results offer important learnings regarding the biology of SOD1-ALS and design of ALS clinical trials…

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Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT™

09/29/2022

SKOUT’s advanced computer vision capabilities enable physicians to detect pre-cancerous lesions in the colon with more accuracy Excerpt from the Press Release: CAMBRIDGE, Mass. & MINNEAPOLIS–(BUSINESS WIRE)–Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced today that SKOUT™…

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2seventy bio Announces Plans to Initiate KarMMa-9 Study of Abecma (idecabtagene vicleucel) in Newly Diagnosed Multiple Myeloma Patients

09/12/2022

This study will evaluate Abecma in patients with suboptimal response to transplant Data from KarMMa-3 and KarMMa-2 studies of Abecma will be presented at future medical meeting Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–2seventy bio, Inc. (Nasdaq: TSVT) today announced plans to initiate the KarMMa-9 study to evaluate Abecma (idecabtagene vicleucel) in newly diagnosed…

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CorDx Granted CE Mark for Two Monkeypox Diagnostic Tests

08/25/2022

Diagnostics enable the detection of the monkeypox virus in humans Excerpt from the Press Release: SAN DIEGO, Aug. 18, 2022 /PRNewswire/ — CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and medical devices, was recently granted a CE Mark certificate for two of the company’s monkeypox diagnostic tests. The CE Mark,…

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Valo Health Announces First Patient Dosed in the OPL-0401 Phase 2 study of an oral ROCK1/2 inhibitor for the Treatment of Non-Proliferative Diabetic Retinopathy

08/23/2022

Excerpt from the Press Release: Valo’s Opal Computational Platform™ being used to select a patient subset within non-proliferative diabetic retinopathy patients at high risk of progressing toward vision-threatening disease BOSTON, Aug. 18, 2022 /PRNewswire/ — Valo Health, Inc. (“Valo”), the technology company focused on transforming the drug discovery and development process using human-centric data and…

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Corcept Therapeutics Initiates ROSELLA – A Pivotal Phase 3 Trial in Recurrent, Platinum-Resistant Ovarian Cancer

07/04/2022

Phase 2 trial showed that relacorilant plus nab-paclitaxel improved progression-free survival, duration of response and overall survival without an increased side effect burden compared to nab-paclitaxel alone Excerpt from the Press Release: MENLO PARK, Calif., June 29, 2022 (GLOBE NEWSWIRE) — Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development…

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