logo
Share SHARE
FONT-SIZE Plus   Neg

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

Protalix BioTherapeutics, Inc. (PLX) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Consumers in Nigeria are calling for a boycott of Coca-Cola products sold in the African nation after a high court judge ruled that the products could be "poisonous". Justice Adedayo Oyebanji of the Lagos High Court ruled that high levels of benzoic acid and sunset additives in Coca-Cola's soft drinks could pose a health risk to consumers when mixed with ascorbic acid, commonly known as Vitamin C. Charles Murphy, a partner at New York hedge fund Paulson & Co., fell to his death after jumping out of a hotel window in Manhattan on Monday. Murphy was found dead on the fourth-floor terrace of the Sofitel New York Hotel after he jumped from a window on the 24th floor. Internet media company BuzzFeed is preparing to go public in 2018, media site Axios reported Wednesday, citing industry sources. New York-based BuzzFeed was founded in 2006 by Jonah Peretti and John Johnson III as a viral lab, focusing exclusively on tracking viral content.
comments powered by Disqus
Follow RTT