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
Home improvement retailer Lowe's Companies Inc. (LOW) has reportedly informed about 2,400 employees that they will be laid off. The majority of the lay offs are at the store level, while other affected positions are at distribution centers, contact centers and at the company's corporate office in... The U.S. Department of Defense and Lockheed Martin Corp. are reportedly nearing a deal worth $9 billion for F-35 fighter planes. President-elect Donald Trump had earlier heavily criticized the Pentagon for overspending on defense contracts. He had specifically noted the F-35 as an example on how Lockheed... PowerBar has selected Olympic swimmer Ryan Lochte for its ad campaign to kick start the "Clean Start Pledge." The energy bar's ad campaign, which focuses on its newer line of "Clean Whey" protein bars, also encourages consumers to participate in sports and fitness exercises to improve their health. The Clean Start Pledge started on January 18.
comments powered by Disqus
Follow RTT