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BioWorld - Wednesday, May 21, 2025
Home » Topics » Clinical

Clinical
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Investigator-led study finds BSX's Acurate Neo not noninferior vs. Edwards' Sapien 3

Sep. 30, 2019
By Stacy Lawrence
SAN FRANCISCO – As the transcatheter aortic valve replacement (TAVR) field matures, it is becoming increasingly difficult to develop a new implant that can distinguish itself vs. competitors. The incremental benefits are narrowing rapidly, making it tough to distinguish new iterations from one another using standard, randomized trials.
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Medtronic gets greenlight for Intrepid TMVR study with transfemoral approach

Sep. 30, 2019
By Meg Bryant

Ancora Heart sees positive early results with Accucinch in systolic heart failure

Sep. 30, 2019
By Liz Hollis

Opportunity abounds in harnessing genomics; so does opportunism

Sep. 30, 2019
By Anette Breindl
BARCELONA, Spain – This year's theme at the European Society for Medical Oncology's (ESMO) 2019 annual meeting is "translating science into better patient care."
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Laying on GAS, Aravive spins early ovarian AXL; will the wheels stay on?

Sep. 30, 2019
By Randy Osborne
Aravive Inc.'s chief medical officer, Gail McIntyre, told BioWorld that a "very clever mechanism" designed by researchers at Stanford University helped lead to positive data from the first 12 patients of the ongoing phase Ib part of the phase Ib/II experiment with AVB-500 against notoriously hard-to-beat ovarian cancer.
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Pfizer reports positive top-line results for JAK1 inhibitor in AD

Sep. 30, 2019
By Lee Landenberger
Pfizer Inc. edged closer to Dermira Inc. in the rush for an approved treatment for atopic dermatitis (AD), a field dominated by Regeneron Pharmaceutical Inc.'s FDA-approved blockbuster, Dupixent (dupilumab), as Pfizer reported positive top-line results from a phase III trial evaluating the efficacy and safety of its oral JAK1 inhibitor, abrocitinib.
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Pascal holds own in one-year CLASP data, as speculation abounds on Mitraclip comparisons

Sep. 27, 2019
By Stacy Lawrence
SAN FRANCISCO – Mitraclip from Abbott Park, Ill.-based Abbott Laboratories, has long been the only minimally invasive mitral valve repair device that's approved by the FDA. Edwards Lifesciences Corp., of Irvine, Calif., aims to challenge that dominance with its Pascal. This week at the Transcatheter Cardiovascular Therapeutics (TCT) conference, positive one-year data from the small CLASP study on Pascal were presented, offering a further glimpse of data for comparison.
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Midstage test of Enanta NASH drug positive, but differentiation questioned

Sep. 27, 2019
By Michael Fitzhugh
Top-line results from Enanta Pharmaceuticals Inc.'s Argon-1 phase IIa study of EDP-305 for the treatment of nonalcoholic steatohepatitis (NASH) found one of the two doses of the drug tested met the study's primary endpoint, alanine aminotransferase (ALT) reduction at week 12, contributing further evidence for the drug's mechanism of action, farnesoid X receptor (FXR) agonism. But the non-biopsy study appears to have left investors without proof for something more even more valuable: a clear case for differentiation vs. FXR first-mover Ocaliva (obeticholic acid, Intercept Pharmaceuticals Inc.). Appearing to reflect the sentiment, Enanta's shares (NASDAQ:ENTA) fell 15.1% to $60.51 on Thursday.
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Study finds AI may be as good as docs at interpreting medical images despite flawed data

Sep. 26, 2019
By Nuala Moran
LONDON – The first systematic review and meta-analysis of the accuracy of artificial intelligence in health care has concluded AI may be as good as clinicians in interpreting medical images, but it is hard to be sure because of the poor quality of published studies. Researchers at Birmingham University, U.K. considered 31,887 journal papers appearing between January 2012 and June 2019, of which 20,530 were screened. They found most were methodologically flawed.
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Corvia launches Interatrial Shunt Device trial using Physiq's biosensor

Sep. 25, 2019
By Annette Boyle
Corvia Medical Inc. is enrolling patients in a 100-site multinational study of its Interatrial Shunt Device that will measure traditional heart failure endpoints as well as biosensor data transmitted to the cloud for analysis by Napier, Ill.-based Physiq's artificial intelligence analytics. The trial will evaluate Tewksbury, Mass.-based Corvia's device in heart failure with preserved and mid-range ejection fraction.
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