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positioned to meet endpoints that could support accelerated approval, according to requirements outlined in new FDA draft guidance.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...
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...
00:55 , Mar 16, 2018 |  BioCentury  |  Emerging Company Profile

Cirius safety

Cirius Therapeutics Inc. is developing a second-generation insulin sensitizer for non-alcoholic steatohepatitis that is designed to avoid cardiovascular symptoms and edema associated with first-generation agents. Insulin-sensitizing thiazolidinediones (TZDs) including Actos pioglitazone from Takeda Pharmaceutical Co....
04:12 , Sep 16, 2017 |  BioCentury  |  Strategy

Passing the baton

When he takes the helm as CEO of Novartis AG in January, Vasant Narasimhan will inherit a business that is still struggling to plug the revenue hole from cancer drug Gleevec imatinib going off patent...
20:34 , Apr 21, 2017 |  BC Week In Review  |  Company News

Allergan, Novartis deal

The companies will test a combination including a farnesoid X receptor (FXR; NR1H4) agonist from Novartis and cenicriviroc from Allergan in a Phase IIb trial to treat non-alcoholic steatohepatitis (NASH). Two of Novartis’ FXR agonists,...
23:13 , Apr 18, 2017 |  BC Extra  |  Company News

Novartis, Allergan planning NASH combo trial

Novartis AG (NYSE:NVS; SIX:NOVN) and Allergan plc (NYSE:AGN) said they will test a combination including a farnesoid X receptor (FXR; NR1H4) agonist from Novartis and cenicriviroc (formerly TBR-652) from Allergan in a Phase IIb trial...
18:32 , Nov 18, 2016 |  BC Week In Review  |  Clinical News

Cenicriviroc: Additional Ph IIb data

Additional data from the double-blind, international Phase IIb CENTAUR trial in 289 NASH patients with liver fibrosis and diabetes or metabolic syndrome showed that 16% of patients receiving once-daily 150 mg oral cenicriviroc for 2...