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 and...
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. Ltd....
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...
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 3SBio...
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 3SBio...
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...
17:39 , Jan 25, 2017 |  BC Innovations  |  Distillery Therapeutics

Renal disease

INDICATION: Renal failure Mouse studies suggest inhibiting ACSL4 could help treat acute renal failure. In a mouse embryonic fibroblast-based assay of ferroptosis, a regulated cell death mechanism associated with acute renal failure, ACSL4 knockout increased viability...
00:36 , Dec 30, 2016 |  BioCentury  |  Regulation

Parting thoughts

Few people have done more to shape how FDA reviews drugs than John Jenkins, who is resigning in January as director of the Office of New Drugs at the Center for Drug Evaluation and Research....
07:00 , Oct 20, 2016 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Parkinson’s disease (PD) Rat studies suggest liposomal delivery of PPARγ agonists could help treat PD. In a rat model of short-term rotenone-induced PD, i.p. liposomes loaded with the PPARγ agonist Avandia decreased retinal ganglion cell...