Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

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
There are just two days to go for the big event of India making its maiden foray to Mars. The nation's first interplanetary probe known as Mars Orbiter Mission (MOM) spacecraft is scheduled to enter the Martian orbit at 7.30 AM IST on September 24, 2014. A US satellite to study Mars' upper atmosphere has entered the Red Planet's orbit. NASA said its Mars Atmosphere and Volatile Evolution (MAVEN) spacecraft successfully entered the orbit at 10:24 p.m. EDT Sunday, completing a 10-month interplanetary journey of 442 million miles, or 711 million kilometers. MAVEN is the first spacecraft dedicated to exploring the tenuous higher atmosphere of Mars. Bundesbank President Jens Weidmann has criticized the European Central Bank's latest measures to boost the euro area economy, such as the planned purchases of covered bonds and asset-backed securities and covered bonds, as well as the interest rate reduction this month. The latest decisions suggest...
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.