22:54 , Nov 9, 2018 |  BioCentury  |  Product Development

Cashing out CVOT

Whether or how much diabetes companies will save by dropping postmarket cardiovascular outcomes trials, if FDA follows the advice of its advisory committee, could boil down to what target they are pursuing and whether they...
21:33 , Oct 23, 2018 |  BC Extra  |  Politics & Policy

FDA meeting will revisit diabetes CVOTs, decade-old controversy

An FDA advisory committee will try to unravel a knot that was tied over a decade ago when FDA and the medical community were rocked by assertions that diabetes drugs were causing deadly heart attacks....
02:10 , Oct 20, 2018 |  BioCentury  |  Product Development

CVOT damage in diabetes

As FDA reconsiders its requirement for cardiovascular outcomes trials of new diabetes candidates, it’s clear that the development of new therapies has slowed since it was implemented. In December 2008, FDA issued guidance requiring diabetes...
23:29 , Sep 17, 2018 |  BC Extra  |  Politics & Policy

FDA to re-examine diabetes CVOT requirements

FDA is reconsidering its policy to require pre- and postmarket cardiovascular outcomes trials for diabetes drugs, and plans to hold an Oct. 24-25 meeting of its Endocrinologic and Metabolic Drugs Advisory Committee to discuss existing...
16:17 , May 3, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Melanoma Mouse studies suggest the PPARγ agonist Avandia rosiglitazone could help treat melanoma. In a mouse model of melanoma, Avandia plus an irradiated GM-CSF-secreting tumor cell vaccine and an anti-CTLA-4 mAb decreased tumor incidence...
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....
21:52 , Oct 5, 2017 |  BC Innovations  |  Strategy

Fixing FDA’s FAERS

Last week FDA announced a new searchable format for its adverse events reporting database, making it easier for drug developers to use the tool to de-risk drug candidates. But according to an August publication from...
20:06 , May 19, 2017 |  BC Week In Review  |  Company News

3SBio acquires China rights to Lilly's Humulin

Eli Lilly and Co. (NYSE:LLY) granted 3SBio Inc. (HKSE:1530) exclusive rights to distribute and promote its diabetes drug Humulin in China, beginning July 1. Lilly's China unit will be responsible for manufacturing the drug, while...
18:49 , May 17, 2017 |  BC Extra  |  Company News

3SBio acquires China rights to Lilly's Humulin

Eli Lilly and Co. (NYSE:LLY) granted 3SBio Inc. (HKSE:1530) exclusive rights to distribute and promote its diabetes drug Humulin in China, beginning July 1. Lilly's China unit will be responsible for manufacturing the drug, while...
01:21 , Jan 27, 2017 |  BC Innovations  |  Targets & Mechanisms

Death metal

The findings in two high profile papers on ferroptosis could be the nudge the fledgling field needs to gain the attention of drug developers. The process is the latest cell death pathway to offer up...