« Return to News | Ethics/Regulatory | Drug Sponsors

Lilly CEO confident in FDA approval

Monday, March 14, 2011 01:31 PM

Eli Lilly CEO John Lechleiter said he's confident of gaining U.S. regulatory approval for a drug to help identify plaque in the brain associated with Alzheimer's disease, according to a Bloomberg News report.

Outside advisers to the FDA voted in January against immediate approval of the medicine, Amyvid, unless the Indianapolis-based drug maker established a training program and a way to ensure that results of brain scans are read consistently. Lilly aims to resolve the FDA panel's concerns in a few months, Lechleiter said in an interview.

"We are confident that we can work with the FDA and gain approval," Lechleiter, 57, said in the Bloomberg report. "This is an imaging agent that we've used in our own clinical studies, so we are very familiar with it."

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.