logo
Share SHARE
FONT-SIZE Plus   Neg

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

Baxter International Inc. (BAX) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Lab equipment maker Thermo Fisher Scientific Inc. has agreed to acquire electron microscope maker FEI Co. for about $4.2 billion in cash, the two companies said Friday. Thermo Fisher noted that FEI's electron microscopy platform will complement its own mass spectrometry systems to accelerate advancements in structural biology. While reporting a wider loss for the first quarter, Sears Holdings Corp. said it has decided to "aggressively evaluate" all potential alternatives for its top brands - Kenmore, Craftsman and DieHard or KCD, and the Sears Home Services or SHS businesses. Sears has retained Citigroup Global Markets and LionTree Advisors to assist in its efforts. Philips Lighting, the splinter group of Dutch consumer electronics giant Philips, saw its shares rally around 8.50 percent on its debut on Friday at the Amsterdam stock exchange. The shares are currently at 21.70 euros, above its set pricing of 20 euros per share.
comments powered by Disqus
Follow RTT