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FDA backs EndoStim's neurostimulation implant for GERD control

The FDA has granted breakthrough device designation to EndoStim for its implantable device which serves as a treatment option for patients with refractory gastroesophageal reflux disease, according to a manufacturer release. The EndoStim System is a neurostimulation device which is implanted laparoscopically and designed to provide long-term reflux control via automatically delivered mild
Eric Goorno Robert Stott Endostim System Stim System
Source: healio.com

FDA rejects Gilead's bulevirtide for hepatitis D, compensated liver disease

The FDA issued a complete response letter to Gilead indicating it cannot approve the company’s new drug application that seeks approval of bulevirtide for chronic hepatitis D virus infection and compensated liver disease. In its letter, the FDA cited concerns over the manufacture and delivery of bulevirtide, a first-in-class investigational entry-inhibitor; however, no new studies to assess
Robert Stott Gilead Sciences European Economic Area
Source: healio.com

First US patient enrolled in Abivax's phase 3 trial of obefazimod for ulcerative colitis

Abivax announced that the first U.S. patient has been enrolled in its global phase 3 clinical trial of its oral small-molecule inhibitor obefazimod for the treatment of moderate to severe ulcerative colitis. The trial will include two induction studies – ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106) – and a subsequent ABTECT maintenance trial (ABX464-107) that will investigate 25
Hartmutj Ehrlich Brucee Sands Henryd Janowitz Robert Stott Icahn School Of Medicine At Mount Sinai Icahn School
Source: healio.com

'One size does not fit all': Cirrhosis care access, mortality vary widely worldwide

LONDON — Cirrhosis severity, infections and mortality outcomes were worse for patients in low to middle-income countries, due in part to poor access to liver transplant and ICU facilities, according to data presented here. “We have health care disparities as well as differing populations and diseases that cause cirrhosis around the world,” Jasmohan S. Bajaj, MD, associate
City Of United Kingdom Jasmohans Bajaj Robert Stott Virginia Commonwealth University International Liver Congress
Source: healio.com

Low-carbohydrate, high-fat diet reduced fatty liver, improved type 2 diabetes control

LONDON — A low-carbohydrate, high-fat diet significantly improved nonalcoholic fatty liver disease activity score and HbA1c more than a high-carbohydrate, low-fat diet in people with type 2 diabetes mellitus, according to a researcher here.
City Of United Kingdom Stephena Harrison Camilla Dalby Hansen Robert Stott Nonalcoholic Steatohepatitis Clinical Research Network
Source: healio.com

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WHO: HCV elimination by 2030 demands 'scale-up, simplification' of care pathways

LONDON —WHO presented updated guidance on hepatitis C, calling for drastic simplification of care pathways to alleviate access gaps in HCV testing and treatment, during a joint WHO-EASL-CDC symposium at the International Liver Congress. “In 2016, when WHO launched its global strategy, there were ambitious plans for elimination, defined as a 90% reduction in incidence and a 65%
City Of United Kingdom Steve Forrest Philippa Easterbrook Robert Stott International Liver Congress
Source: healio.com

Registry trials can provide revenue 'backbone' for gastroenterology practice

MIAMI — Incorporating clinical trials into daily practice can both enhance patient treatment options and provide a stream of reimbursement revenue to support the practice, according to a presenter at the Scrubs and Heels Summit. “In my practice, I always ask myself, no matter where a patient is in the course of disease: Would this patient potentially benefit from inclusion in a
United States Robert Stott University Of North Carolina At Chapel Hill Dont Have Walk Alone Wheels Summit
Source: healio.com

Effective male allies 'recruit, train and retain' female gastroenterologists

MIAMI – Female gastroenterologists continue to be underrepresented in leadership positions and earn less than their male counterparts, spotlighting a critical ally role for males, noted a presenter at Scrubs and Heels Summit.Despite some progress in the field, gender gaps persist in pay and promotions – and not for lack of female presence in the pipeline.
United States Samira Shah Robert Stott Brown University Alpert Medical School Dont Have Walk Alone
Source: healio.com

Surgery risk for IBD declining in biologic era, 'but that doesn't mean it's zero'

Although the rate of surgery for inflammatory bowel disease has declined significantly in the era of biologic therapy, “it is still occurring,” according to a presenter at the Crohn’s and Colitis Congress. “If you think in terms of risk, about what the most disabling situation is when it comes to ulcerative colitis, it’s probably surgery, and most patients would like
San Diego United States Angelina Collins Robert Stott Uc San Diego Health Inflammatory Bowel Disease Center
Source: healio.com

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