BioCentury | Mar 9, 2020

FDA dropping CVOT requirement for diabetes drugs

Editor’s note: This story has been updated to reflect details contained in FDA’s guidance. Twelve years after FDA issued draft guidance that made it exorbitantly expensive to bring a new diabetes therapy to market, the...
BC Innovations | Jan 29, 2019
Distillery Therapeutics


INDICATION: Melanoma Patient sample and mouse studies suggest promoting UCP2 expression could help treat melanoma. In patients, high tumor levels of UCP2 mRNA were associated with survival. In two mouse models of melanoma, tumor-specific overexpression...
BioCentury | Nov 9, 2018
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...
BC Extra | Oct 23, 2018
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....
BioCentury | Oct 20, 2018
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...
BC Extra | Sep 17, 2018
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...
BC Innovations | May 3, 2018
Distillery Therapeutics


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...
BioCentury | Mar 16, 2018
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....
BC Innovations | Oct 5, 2017

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...
BC Week In Review | May 19, 2017
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...
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