New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 4, 2013
19:39 EDTHEBFDA declines to approve Hemispherx's Ampligen new drug application
Hemispherx Biopharma announced that it received a complete response letter from the US Food and Drug Administration declining to approve its new drug application for Ampligen for Chronic Fatigue Syndrome. The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. In its complete response letter, the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. Hemispherx plans to request an end-of-review conference with the FDA as a precursor to submitting a formal appeal to the office of new drugs in the FDA's center for drug evaluation and research regarding the agency's decision
News For HEB From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
November 17, 2014
09:27 EDTHEBHemispherx says Ampligen blocks certain Ebola Viral Disease protein
Hemispherx Biopharma announced that it had received a new research report from Professor Tramontano in the Department of Life and Environmental Sciences, University of Cagliari, Italy. The biochemical study demonstrates Ampligen can successfully bind to the lethal EVD viral protein designated VP35. Experiments being conducted establish the scientific foundation for Ampligen, an experimental drug, as a potential preventive and early onset therapeutic for Ebola, the company said.
November 10, 2014
08:48 EDTHEBHemispherx reports Q3 EPS (2c), one estimate (3c)
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use