21:58 , Apr 26, 2019 |  BioCentury  |  Product Development

Rise of the independents, biotechs go to market

While product launch and commercialization has largely been the province of big biotech and big pharma, with smaller companies partnering to get their products over the finish line, BioCentury’s analysis of recent FDA approvals finds...
22:44 , Apr 25, 2019 |  BC Extra  |  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...
19:57 , Apr 12, 2019 |  BC Extra  |  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...
19:21 , Apr 11, 2019 |  BC Extra  |  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...
17:29 , Apr 11, 2019 |  BC Extra  |  Clinical News

Intercept EASL data continue to fuel investor concerns

Additional data presented Thursday at EASL for Intercept's Ocaliva obeticholic acid (OCA) to treat NASH address some lingering efficacy questions from physicians, but safety signals and Intercept’s latest analysis methods continue to spook investors as...
22:34 , Mar 29, 2019 |  BC Extra  |  Clinical News

Pfizer's ketohexokinase inhibitor decreases liver fat content in NAFLD Phase II

As Pfizer considers which combination therapies to develop for NASH, the pharma reported that its KHK inhibitor, PF-06835919, as monotherapy reduced whole liver fat in a Phase II trial to treat non-alcoholic fatty liver disease....
01:26 , Feb 28, 2019 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Colorectal cancer Patient sample, cell culture and mouse studies suggest agonizing FXR could help treat colorectal cancer. In colorectal cancer patient samples, low tumor expression of an FXR-induced gene signature was associated with poor...
02:03 , Feb 23, 2019 |  BioCentury  |  Product Development

Benchmarks for NASH

Benchmarking clinical value in NASH will require more than the topline data reported this week by Intercept Pharmaceuticals Inc. The readout gained Ocaliva obeticholic acid the title of first NASH therapy to meet in Phase...
16:57 , Feb 22, 2019 |  BC Week In Review  |  Clinical News

Intercept's NASH therapy heads for submissions after meeting Phase III endpoint

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) intends to submit regulatory applications next half for obeticholic acid (OCA) after new data showed the compound met one of two primary endpoints in the Phase III REGENERATE trial to treat...
17:52 , Feb 19, 2019 |  BC Extra  |  Clinical News

Intercept's NASH therapy heads for submissions after meeting Phase III endpoint

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) intends to submit regulatory applications next half for obeticholic acid (OCA) after new data showed the compound met one of two primary endpoints in the Phase III REGENERATE study to treat...