BioTech 365

MAY 24, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: NGM’s closely-watched NASH prospect flops, cutting shares in half and spurring R&D rethink.NGM’s closely-watched NASH prospect flops, cutting shares in half and spurring R&D rethink ntaylor Mon, … Continue reading (..)

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Research 40

BioTech 365

OCTOBER 1, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: After disastrous NASH crash, Genfit slashes jobs and splits operations into 2.After

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Research 40

Pharmaceutical Technology

APRIL 21, 2023

In a statement emailed to Endpoints News , AstraZeneca (AZ) disclosed intentions to terminate its clinical program for its daily glucagon-like peptide-1 receptor glucagon co-agonist (GLP-1RA/GCGR) cotadutide, in favour of focusing on the development of AZD9550, its once-weekly injectable GLP-1RA/GCGR.

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BioTech 365

OCTOBER 27, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Pfizer Q3 cull sees midstage fast-tracked NASH drug axed, with a cancer vaccine and arthritis asset also chopped.Pfizer Q3 cull sees midstage fast-tracked NASH drug axed, with … Continue reading →

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Vaccination Vaccine Drugs Research 40

pharmaphorum

DECEMBER 10, 2021

Already scrambling to refile its obeticholic acid (OCA) drug for non-alcoholic steatohepatitis (NASH) after the FDA rejected it last year, Intercept Pharma was hoping for more luck in Europe, but has now withdrawn its EU marketing application. Shares in Intercept slipped around 15% after it announced the news.

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Drug Discovery World

DECEMBER 7, 2023

Inipharm has initiated Phase I dosing of its lead candidate, INI-822, which is a small-molecule inhibitor for HSD17B13, a gene implicated in nonalcoholic steatohepatitis (NASH). CN Bio’s PhysioMimix Organ-on-a-Chip (OOC) Systems and NASH ‘in-a-box’ (NIAB) kit was used to provide human-relevant data on compound efficacy for INI-822.

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Drugs In-Vivo Gene Development 59

pharmaphorum

FEBRUARY 1, 2022

After a phase 3 trial win, Madrigal Pharmaceuticals reckons it could succeed where so many other companies have failed, and finally bring a drug to market to treat the liver disease non-alcoholic steatohepatitis (NASH). The discontinuation rate due to adverse events with the drug was just over 2%.

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pharmaphorum

AUGUST 25, 2022

That was until my doctors stunned me with the news that I had cirrhosis caused by non-alcoholic steatohepatitis, or NASH, a severe form of fatty liver disease that often has few or no symptoms until very late stages. Of those, 5 million will progress to NASH cirrhosis. That is a moral failure on the part of medicine.

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Development Drugs Trials Medicine 98

pharmaphorum

JUNE 9, 2021

He also thinks Intercept Pharma could get an indirect benefit for its Ocaliva (obeticholic acid) product as it tries to find common ground with the FDA on a potential use in non-alcoholic steatohepatitis (NASH) – another widespread indication with massive unmet need.

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Drugs Gene Therapy Marketing Regulation 73

The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Theratechnologies received the go-ahead from the FDA to launch its Phase III trial for tesamorelin for adults with nonalcoholic steatohepatitis (NASH) with liver fibrosis. Here’s a look. COVID-19-Related.

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Gene Therapy Trials Gene Clinical Trials 52

Pharma Times

JANUARY 10, 2024

The £30m ADVANCE study is the most extensive study into liver disease worldwide

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Development 84

XTalks

SEPTEMBER 2, 2020

The study also demonstrated that liver fat content was significantly decreased in patients that received VK2809, regardless of baseline characteristics and common risk factors for non-alcoholic steatohepatitis (NASH) such as Hispanic ethnicity, hypertension or a body mass index (BMI) greater than 30.

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pharmaphorum

DECEMBER 10, 2021

The financing involved new and existing backers, which have not been identified, and will be directed mainly to LIVErHEALTHY, a digital health programme that was launched by ChronWell last year. ModifyHealth’s meal plans help patients lose weight, the first line of treatment of NAFLD and NASH.

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Development 73

pharmaphorum

OCTOBER 1, 2022

Intercept Pharma’s hopes of getting its non-alcoholic steatohepatitis (NASH) therapy obeticholic acid (OCA) in the US may have taken another dive, after it flunked a phase 3 trial. In turn that “underscores the importance of treating liver fibrosis due to NASH before it progresses to cirrhosis,” she added.

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Trials FDA Approval Clinical Trials Clinical Trials 57

pharmaphorum

SEPTEMBER 30, 2022

Denmark’s Novo Nordisk has agreed to pay $70 million to license rights to a drug developed by Ventus Therapeutics with potential in non-alcoholic steatohepatitis (NASH) and several other diseases associated with inflammation. Once again, NASH was trumpeted as the primary focus of that deal, along with gout and atherosclerosis.

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pharmaphorum

MAY 24, 2021

Shares in NGM Biopharma have plummeted after the US biotech said it would abandon development of aldafermin in non-alcoholic steatohepatitis (NASH), adding to a lengthening list of failed candidates for the fatty liver disease. . The post NGM craters after dropping mid-stage NASH candidate aldafermin appeared first on.

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pharmaphorum

NOVEMBER 23, 2021

GlaxoSmithKline has joined the ranks of drugmakers trying to develop new drugs for non-alcoholic steatohepatitis (NASH) – a condition with no approved therapies and a lengthy list of failed drug candidates – via a deal with Arrowhead Pharmaceuticals.

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pharmaphorum

NOVEMBER 16, 2020

Gilead and Novo Nordisk have announced their drug combinations for the fatty liver disease known as NASH checked out in a mid-stage proof-of-concept study. The companies said the trial met its primary safety goal in people with non-alcoholic steatohepatitis (NASH) but stopped short of announcing any further plans for clinical development.

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Trials Clinical Trials Clinical Trials Clinical Development 62

Delveinsight

DECEMBER 15, 2020

Gannex received US FDA fast track designation for its NASH drug, ASC42 an FXR Agonist. Gannex Pharma has received Fast Track designation approval from FDA for its drug candidate ASC42 for non-alcoholic steatohepatitis (NASH). At present, there are no approved therapies for NASH.

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Vaccination Vaccine Gene Therapy Gene 54

pharmaphorum

JANUARY 6, 2021

million – including $175 million upfront and an equity investment of $50 million – to find multiple RNA interference (RNAi) candidates for diseases like non-alcoholic steatohepatitis (NASH) and type 2 diabetes. In 2019 the Danish company also licensed a preclinical-stage, small-molecule candidate for NASH from Japan’s UBE.

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Gene Silencing Gene RNA Contract Manufacturing 58

pharmaphorum

MARCH 18, 2021

Gilead is one of many pharmas chasing mega-bucks promised by the fatty liver disease known as NASH – but after several failures the company is expanding a partnership with Novo Nordisk based on combination therapies including the Danish pharma’s semaglutide.

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The Pharma Data

MAY 13, 2021

The good news is, these symptoms are completely reversible – and WITHOUT resorting to prescription drugs or unrealistic diets. In non-alcoholic steatohepatitis (a type of fatty liver disease also known as NASH), the chance of progression to life threatening liver cirrhosis is quoted up to 26 percent over a 7 year period.

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pharmaphorum

JANUARY 6, 2021

Analysts are continuing to back Inventiva’s lanifibranor as a potential “best-in-class” drug for the fatty liver disease NASH, as the company prepares for the launch of a phase 3 trial in spring. There are no approved drugs for NASH – full name non-alcoholic steatohepatitis – after the FDA rejected Intercept’s obeticholic acid last year.

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Gene Silencing Regulation Pharma Companies Doctors 52

pharmaphorum

AUGUST 5, 2020

Merck & Co is to pay $10 million to Hanmi to repurpose an obesity drug discarded by Johnson & Johnson, into a therapy for the fatty liver disease known as NASH. Now US-based Merck wants to see if it can get Hanmi’s drug, known as efinopegdutide, to work in NASH after J&J walked away from developing it in obesity.

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The Pharma Data

MAY 14, 2021

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Doctors Doctor Production Medicine 52

The Pharma Data

JANUARY 3, 2021

It’s not particularly surprising that there wasn’t a lot of clinical trial news between Christmas and New Year’s, although there was some. Hepion Pharmaceuticals announced the DSMB had approved continuation of its Phase IIa AMBITION trial of CRV431 in non-alcoholic steatohepatitis (NASH). Here’s a look. COVID-19-Related.

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The Pharma Data

SEPTEMBER 15, 2020

Key updates included: Phase 2a data for the potential first-in-class combination of clesacostat (PF-05221304), an investigational acetyl-CoA carboxylase inhibitor (ACCi), and ervogastat (PF-06865571), an investigational diacylglycerol acyltransferase 2 inhibitor (DGAT2i), for the treatment of non-alcoholic steatohepatitis (NASH).

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