18:43 , Dec 5, 2018 |  BC Extra  |  Politics & Policy

FDA NASH guidance charts course for surrogate endpoints tied to biopsies

Four companies with products in Phase III testing to treat non-alcoholic steatohepatitis are well positioned to meet endpoints that could support accelerated approval, according to requirements outlined in new FDA draft guidance. However, the guidance...
19:20 , Nov 19, 2018 |  BC Extra  |  Financial News

NASH company Genfit planning U.S. listing

As it prepares for a readout from a Phase III study of its lead candidate to treat non-alcoholic steatohepatitis, French bellwether Genfit S.A. (Euronext:GNFT) intends to conduct a listing on a U.S. exchange. Genfit said...
18:49 , Nov 13, 2018 |  BC Innovations  |  Distillery Therapeutics

Autoimmune disease

INDICATION: Arthritis Mouse studies suggest inhibiting MCP-1 or its receptor CCR2 could help treat arthritis. In a mouse model of anti-collagen antibody-induced arthritis, systemic MCP-1 knockout or a neutralizing antibody against CCR2 decreased disease severity...
02:27 , Nov 3, 2018 |  BioCentury  |  Product Development

New partners for NASH

Pharmas are loading up their NASH portfolios expecting that addressing the full disease spectrum will require combinations, though the field lacks the tools to sort the different mechanisms on offer strategically. Meanwhile, at least three...
19:53 , Nov 2, 2018 |  BC Week In Review  |  Company News

Pfizer, Novartis in NASH deal with multiple MOAs

Pfizer Inc. (NYSE:PFE) and Novartis AG (NYSE:NVS; SIX:NOVN) partnered to test Novartis' tropifexor (LJN452) in combination with three compounds from Pfizer with different mechanisms of action to treat non-alcoholic steatohepatitis. The partners will conduct preclinical...
20:30 , Oct 29, 2018 |  BC Extra  |  Company News

Pfizer, Novartis in NASH deal with multiple MOAs

Pfizer Inc. (NYSE:PFE) and Novartis AG (NYSE:NVS; SIX:NOVN) partnered to test Novartis' tropifexor (LJN452) in combination with three compounds from Pfizer with different mechanisms of action to treat non-alcoholic steatohepatitis. The partners will conduct preclinical...
19:32 , Sep 10, 2018 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Encephalopathy Patient sample and mouse studies suggest inhibiting the JAK/STAT1 pathway, the interaction between MCP-1 and CCR2, or phagocyte activation could help treat Rasmussen encephalitis. In postmortem brain samples from patients, levels of phosphorylated...
19:30 , Jun 15, 2018 |  BC Week In Review  |  Company News

ChemoCentryx, Vifor Fresenius expand CCX140, avocapan deal to include China

ChemoCentryx Inc. (NASDAQ:CCXI) granted Vifor Fresenius Medical Care Renal Pharma Ltd. exclusive rights to commercialize avacopan (CCX168) and CCX140 in China under the second expansion of a 2016 deal. Vifor Fresenius gained exclusive commercialization rights...
20:56 , May 1, 2018 |  BC Extra  |  Company News

Read says Pfizer not looking toward M&A

Pfizer Inc. (NYSE:PFE) Chairman and CEO Ian Read said the pharma is focusing investments on its own pipeline rather than M&A. "I don't see that we need a transformative deal, nor do I see one...
16:40 , Jan 26, 2018 |  BC Week In Review  |  Clinical News

ChemoCentryx reports OS data for CCR2 antagonist in pancreatic cancer

ChemoCentryx Inc. (NASDAQ:CCXI) said CCX872 plus FOLFIRINOX chemotherapy led to an 18-month overall survival rate of 29% in a Phase Ib trial to treat advanced non-resectable pancreatic cancer. The company will present the data at...