Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

FDA Seeks Addl Information To Complete Review Of HyQ BLA - Quick Facts

RELATED NEWS
Trade BAX now with 

Baxter International Inc. (BAX: Quote) and Halozyme Therapeutics Inc. (HALO) announced that the U.S. Food and Drug Administration is requesting additional information to complete its review of the HyQ Biologics License Application or BLA.

Baxter and Halozyme said that they will work closely together to develop studies to provide additional data to address concerns raised by the FDA related to the long-term chronic use of HyQ. The companies now expect to participate in a meeting of the FDA's Blood Products Advisory Committee concerning the agency's request for additional data.

The companies expect these requests to require additional time to complete and to delay the companies' anticipated regulatory review and approval timeline.

Click here to receive FREE breaking news email alerts for Baxter International Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Global consumer confidence increased in the second quarter to reach the highest levels since the first quarter in 2007 as job optimism improved, results of a survey by Nielsen showed Tuesday. The Nielsen Global Consumer Confidence Index rose a point from the previous quarter to 97 in the second quarter.... Texas Instruments Inc., the world's largest maker of analog chips, said Monday after the markets closed that its second quarter profit rose 3% from last year, as revenue increased 8%. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue. At the same time, the company gave an upbeat outlook for the third quarter. After coming under pressure in early trading on Monday, stocks regained some ground over the course of the trading session but still closed modestly lower. The pullback on the day partly offset the strength that was seen last week.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.