Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Protalix Says FDA Extends Taliglucerase Alfa PDUFA Date To May 1, 2012

RELATED NEWS
Trade PLX now with 

Protalix BioTherapeutics, Inc. (PLX: Quote) Tuesday said it has received notification from the U.S. Food and Drug Administration that the FDA has extended the Prescription Drug User Fee Act goal date of the New Drug Application for taliglucerase alfa to May 1, 2012, a three-month extension from the previous PDUFA date of February 1, 2012.

Taliglucerase alfa is the Company's proprietary plant cell expressed recombinant form of human Glucocerebrosidase, which is being developed for the treatment of Gaucher disease.

In November 2011, the Company submitted certain clinical information regarding taliglucerase alfa in response to an FDA request. This request related mainly to the presentation of select data provided in the NDA.

Click here to receive FREE breaking news email alerts for Protalix BioTherapeutics Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Consumers spent less in July than in the previous month, a surprise retreat that complicates the prevailing belief that the U.S. economic situation is improving. Along with the unexpected drop in spending, government figures released on Friday showed that incomes rose at a slower pace in July than in the previous month. Meanwhile, data on prices indicated that inflation pressures remain tame. India's economy grew faster-than-expected in the three months to June and at the strongest pace in two years, preliminary figures from the Central Statistics Office revealed Friday. Gross domestic product grew 5.7 percent in the April to June quarter, which exceeded economists' forecast for 5.5 percent expansion. The economy grew 4.6 percent in the previous three months. Eurozone inflation slowed as expected in August on falling energy prices giving room for the central bank to support demand and economic recovery without stoking inflation and help the region to create more jobs. The unemployment rate remained unchanged at an elevated level in July. Nonetheless, it was at the lowest since September 2012.
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.