« Return to News | Drug Sponsors | Ethics/Regulatory

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

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.