Categories
Cardiovascular
Diagnostics
Endocrinology
Health Insurance
Medical Devices
Mental Health
Nutrition
Oncology
Public Health
Sexual Health
Popular Articles

American Dental Education Association Releases Statement On Professionalism In Dental Education
The American Dental Education Association (ADEA) has released a Statement on Professionalism in Dental Education for the academic dental community. Aligned with existing codes of ethics and conduct within the dental education and dental practice communities, the Statement helps to define expectations for professional behavior in dental education institutions. It includes the values and behaviors that should guide students as they enter the dental and allied dental professions and faculty and administrators as they continuously improve their educational programs.

News Conference: Physicians Invite President Obama To Texas' Border To See Health Care Delivery System
What
News of the day
Transcept Pharmaceuticals Announces Expected FDA Extension Of Regulatory Review Period For Intermezzo(R)
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual tablet). The Intermezzo(R) NDA had been assigned a Prescription Drug User Fee Act (PDUFA) date of July 30, 2009. Under this revised timeline, Transcept now anticipates action from the FDA on the NDA on or before October 31, 2009.
Endocrinology

Protalix Holds Pre-NDA Meeting With FDA For PrGCD For The Treatment Of Gaucher Disease

Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced that the Company held a pre-NDA meeting with the U.S. Food and Drug Administration (FDA). The purpose of the meeting was to discuss the a proposed new drug application (NDA) submission for prGCD, a new proprietary plant-cell expressed recombinant form of glucocerebrosidase, for the treatment of Gaucher disease and to confirm the clinical, nonclinical and chemistry requirements for the proposed NDA filing. prGCD is currently the subject of a pivotal Phase III clinical trial being conducted under the FDA"s Special Protocol Assessment (SPA) for the treatment of Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms. "This meeting gives us confidence that we will be able to submit the NDA as planned and brings us one step closer to our goal of making prGCD commercially available to Gaucher disease patients through their treating physicians," said Dr. David Aviezer, President and Chief Executive Officer. "We look forward to announcing the results of our ongoing pivotal Phase III clinical trial for prGCD in the fourth quarter of 2009 and anticipate submitting the NDA before the end of the year." Protalix BioTherapeutics


Add your comment:
Name:
Site address: http://
Your message:
Enter today\\\\'s date, 2 digits
(spam protection):

© Copyright 2009