logo
Share SHARE
FONT-SIZE Plus   Neg

Baxter, Halozyme Issue Update On HyQ Biologics License Application

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

Both the companies 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. At present, the companies 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 their anticipated regulatory review and approval timeline.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Snacks giant Mondelez International Inc. (MDLZ) made a takeover bid of $23 billion to acquire chocolate behemoth Hershey Co. (HSY) that would create the world's largest chocolate company. Nevertheless, shares of Hershey jumped over 15 percent after the company revealed that it has rejected the offer. "The... Mortgage rates dropped this week to the lowest level in more than three years hurt by the UK's shocking decision to exit European Union. Releasing the results of its primary mortgage market survey, Freddie Mac said that the 30-year fixed-rate mortgage or FRM averaged 3.48 percent for the week ended... Walt Disney Co. (DIS) have installed new signs and temporary barriers across it parks and resorts warning against alligators. References, jokes and appearances of crocodiles eating children have also been cut. Walt Disney World made these changes after the death of 2-year old Lane Graves, who was...
comments powered by Disqus
Follow RTT