National Institutes of Technology (India)

Data from 89bio’s ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Nonalcoholic Steatohepatitis (NASH) Published in The New England Journal of Medicine and Simultaneously Presented in a Late-breaker Session at the EASL International Liver Congress

Retrieved on: 
Saturday, June 24, 2023
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SAN FRANCISCO, June 24, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today announced that data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis (NASH) were published online in the New England Journal of Medicine (NEJM). The data were simultaneously presented in a late-breaking oral session today at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna, Austria and were also selected for inclusion in the Best of EASL Congress summary.

Key Points: 
  • The published manuscript titled “A Randomized, Controlled Trial of the FGF21 Analog Pegozafermin in NASH” is available online.
  • A copy of the EASL oral presentation will be accessible under “Scientific Publications” in the pipeline section of 89bio’s website .
  • Treatment with pegozafermin also led to clinically meaningful changes compared to baseline in liver fat and other key non-invasive tests (NITs) of liver inflammation and fibrosis.
  • Five out of eleven of these patients treated with pegozafermin had fibrosis improvement ≥1 stage without worsening of NASH.

IFF Names New President of Nourish and Introduces Leadership Structure Aligned to New Operating Model

Retrieved on: 
Wednesday, June 7, 2023
Cosmetics, Retail, Chemicals, Plastics, Manufacturing, Specialty, Food, Beverage, Christophe, University, ICI, Kellogg, Engineering, Marketing, DuPont, CPG, Registered trademark symbol, Faculty of Management Studies – University of Delhi, All rights reserved, Herriott, Nutrition and Health, Science, Creativity, Personal care, Strategic management, Paweł Strzelecki, National Institutes of Technology (India), Corporation, Osaka Titanium Technologies, Zeneca, Growth, Cereal, International Flavors & Fragrances, NYSE, Odor, Drug, Management, Perfume, IFF, Health, Beach nourishment

IFF today also announced the leadership structure to support the transition to a new operating model as part of the company’s transformation strategy.

Key Points: 
  • IFF today also announced the leadership structure to support the transition to a new operating model as part of the company’s transformation strategy.
  • IFF expects its new operating model to be in effect by the beginning of 2024.
  • As President, Nourish, Arora, will lead IFF’s Food and Beverage categories when the operating model is in full effect in the new year.
  • “Our evolution to a category-aligned operating model is a pivotal moment for IFF,” said Frank Clyburn, IFF CEO.

Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

Retrieved on: 
Friday, May 19, 2023
Intercept, Therapy, NASH, Advisory Committee, NDA, Patient, Intercept Pharmaceuticals, OCA, PDUFA, Fatty liver disease, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, National Institutes of Technology (India), Food, Safety, Pharmaceutical industry

MORRISTOWN, N.J., May 19, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced the outcome of the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting to review the Company’s New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).

Key Points: 
  • “We continue to disagree with the FDA on certain characterizations of OCA’s efficacy and safety in pre-cirrhotic fibrosis due to NASH and the role of non-invasive tests (NITs), as discussed in today's meeting.
  • As previously reported, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 22, 2023.
  • The conference call will be available via a listen-only webcast on the investor page of the company’s website at http://ir.interceptpharma.com .
  • A replay of the call will be available on the Intercept website shortly following the completion of the call and will be available for one year.

89bio’s Phase 2b ENLIVEN Trial of Pegozafermin in Nonalcoholic Steatohepatitis (NASH) Achieved High Statistical Significance on Both Primary Histology Endpoints with Weekly (QW) and Every-Two-Week (Q2W) Dosing at 24 Weeks

Retrieved on: 
Wednesday, March 22, 2023
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Pegozafermin continued to demonstrate a favorable safety and tolerability profile consistent with prior studies.

Key Points: 
  • Pegozafermin continued to demonstrate a favorable safety and tolerability profile consistent with prior studies.
  • A total of five patients treated with pegozafermin were discontinued due to treatment-related AEs all of which were Grade 2 compared with none for placebo.
  • The webcast can be accessed live here and on the Events & Presentations page in the Investors section of the 89bio website, www.89bio.com.
  • The webcast will be archived on 89bio’s website for at least 30 days after the conference call.