03:03 , Feb 15, 2019 |  BC Innovations  |  Tools & Techniques

Heartening predictors in diabetes

New biomarkers of cardiovascular risk could relieve a decade-old bottleneck for diabetes drug development, but validating them will require companies to invest in strategic trial designs, and public and private stakeholders to pool thinking. As...
03:56 , Feb 4, 2017 |  BioCentury  |  Strategy

Lawyers, drugs and money

Heading into 2017, investor consensus held that positive CV outcomes data for Amgen Inc. ’s Repatha evolocumab could provide a commercial boost to PCSK9 inhibitors. But with top-line results now in hand, payers, PBMs and...
08:00 , Mar 5, 2015 |  BC Innovations  |  Strategy

Cardio reboot

A two-year-old FDA initiative is progressing toward its goal of replacing clinical QT studies with preclinical assays that do a better job at predicting proarrhythmia side effects. The question is what impact replacing QT will...
08:00 , Jan 27, 2014 |  BioCentury  |  Regulation

Follow-up rigor

A focus on follow-up made the conduct and execution of Merck & Co. Inc.'s CV outcomes trial for Zontivity vorapaxar a model of rigor that FDA's Cardiovascular and Renal Drugs Advisory Committee expects future trials...
07:00 , Aug 5, 2013 |  BioCentury  |  Regulation

Rushing to abandon tQT

FDA 's Norman Stockbridge wants to abandon thorough QT studies by 2015, replacing them with a preclinical assay suite better able to detect proarrhythmia side effects than existing assays. However, it remains unclear whether two...
00:47 , Jun 19, 2013 |  BC Extra  |  Politics & Policy

FDA to discuss alternatives to QT studies

FDA is holding a public workshop on July 23 to discuss preclinical methods to assess arrhythmia risk including the risk of torsades de pointes during the drug development process as an alternative to clinical thorough...