BioCentury | May 6, 2020
Product Development

Phase II data show Novo’s semaglutide leads the pack on NASH resolution

Novo Nordisk disclosed top-line Phase II data in NASH for semaglutide that puts the GLP-1 agonist in pole position with respect to mechanisms addressing NASH resolution. The readout came as Novo Nordisk A/S (CSE:NOVO B;...
BC Extra | Dec 17, 2019
Company News

Dec. 16 Company Quick Takes: Greenlight for Roche-Spark deal; plus BMS, Gilead, BioMarin, FDA guidance

Roche cleared to complete Spark takeover  The planned merger of Roche (SIX:ROG; OTCQX:RHHBY) and Spark Therapeutics Inc. (NASDAQ:ONCE) has at last been cleared by the U.S. Federal Trade Commission and U.K. Competition and Markets Authority....
BC Innovations | Nov 27, 2019
Product Development

Early Pfizer data from DGAT2-targeting NASH program lay groundwork for monotherapy and combos

Pfizer thinks Phase I and preclinical data from its DGAT2 program suggest the target could hit NASH's three mechanistic pillars -- dysregulated metabolism, inflammation and fibrosis. The pharma is advancing a next-generation compound both alone...
BC Innovations | Oct 25, 2019
Tools & Techniques

NASH: how non-invasive biomarkers promise to displace biopsies

Non-invasive biomarkers in NASH are beginning to show where and how they can upstage liver biopsies, with the first impact appearing in patient recruitment. The biggest value will come when they can serve as regulatory...
BC Extra | Jul 2, 2019
Company News

Boehringer races to catch up in NASH through Yuhan deal

Boehringer is playing catch up in NASH through a preclinical deal with Yuhan that doubles its programs in the indication from one to two and marks its entry into combining therapeutic MOAs -- a strategy...
BC Extra | Apr 25, 2019
Clinical News

Gilead looks towards NASH combo data after selonsertib fails in second Phase III

Gilead's selonsertib has failed in another Phase III NASH trial, this time missing the primary endpoint in patients with a less severe stage of fibrosis. The company will focus on its combination strategy to treat...
BC Extra | Apr 12, 2019
Company News

Gilead, Novo team up to combine NASH compounds

A day after Gilead presented Phase II data at EASL for its cilofexor plus firsocostat combination to treat non-alcoholic steatohepatitis, the company partnered with Novo Nordisk to test the duo in combination with semaglutide in...
BC Extra | Apr 11, 2019
Clinical News

Gilead’s NASH combo data suggest benefit, safety

Phase II combination data presented by Gilead at EASL could begin to lay the groundwork for what MOAs will be essential parts of combinations in non-alcoholic steatohepatitis. In a Phase II proof-of-concept trial in 20...
BC Week In Review | Feb 15, 2019
Clinical News

Gilead’s selonsertib fails Phase III for NASH compensated cirrhosis

Gilead Sciences Inc. (NASDAQ:GILD) said selonsertib (GS-4997) missed the primary endpoint in the Phase III STELLAR-4 trial to treat compensated cirrhosis due to non-alcoholic steatohepatitis (NASH). Selonsertib is an oral small molecule ASK1 inhibitor. The...
BC Extra | Feb 12, 2019
Clinical News

Gilead’s selonsertib fails Phase III for NASH compensated cirrhosis

Gilead Sciences Inc. (NASDAQ:GILD) said selonsertib (GS-4997) missed the primary endpoint in the Phase III STELLAR-4 trial to treat compensated cirrhosis due to non-alcoholic steatohepatitis (NASH). Selonsertib is an oral small molecule ASK1 inhibitor. The...
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