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
Germany's unemployment increased unexpectedly in August as worsening economic activity weighed on job creation. In addition, consumer price inflation, at a four-and-a-half-year low, boosted the scope for more stimulus from the European Central Bank. The number of people out of work increased by a seasonally adjusted 2,000 persons to 2.901 million in August, the Federal Labor Agency reported. NASA has approved the development of the world's most powerful rocket, designed to take humans beyond Earth orbit and to Mars. NASA officials Wednesday announced they have completed a rigorous review of the Space Launch System (SLS) -- the heavy-lift, exploration class rocket under development - and approved the program's progression from formulation to development, something no other exploration Eurozone economic confidence weakened more-than-expected in August to its lowest level in eight months, underscoring rising pessimism amid heightened geopolitical tensions and stagnating economic recovery. The economic confidence index fell to 100.6 in August, the lowest score since December, from 102.1 in July, the European Commission said Thursday.
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.