SAN FRANCISCO – Abbott Laboratories expects that its self-expanding transcatheter aortic valve replacement (TAVR) system Portico will be able to become a top competitive product. A pivotal trial of Portico has found that the implant is noninferior to current FDA-approved TAVR systems that are marketed in the U.S. The results from the 750-patient, randomized trial were presented here last week at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

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.

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."

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.

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.

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.

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.

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.