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.
August 26, 2015
10:01 EDTHEBHemispherx says court upholds defense in case brought by Cato Capital
Hemispherx Biopharma announced that on Friday the Third Circuit Court of Appeals upheld the company's defense of a case brought by Cato Capital, one of its former investment banks, thus affirming the trial court judgment Hemispherx obtained in September 2014, when the company fully prevailed in a federal lawsuit brought against the company following trial. The appellate panel affirmed the United States District Court for the District of Delaware, which had dismissed all claims against Hemispherx and subsequently ordered Cato to pay Hemispherx attorney's fees and costs in the amount of $770,852.76.The company's President, Thomas K. Equels, stated: "We are gratified that the distinguished panel vindicated our interpretation of the contract. Our lead counsel, James J. Black, III did an outstanding job interpreting this Delaware law based agreement, and properly navigating this dispute through the courts. Now, in furtherance of our corporate policy to seek redress against plaintiffs who bring meritless claims against the company, we will pursue Cato Capital to the fullest extent of the law to collect on the award of attorney's fees and costs."
August 24, 2015
08:37 EDTHEBHemispherx enters into supply agreement with Gulf Coast Regional Blood Center
Subscribe for More Information
August 19, 2015
14:02 EDTHEBHemispherx to hold an open house
Subscribe for More Information
August 17, 2015
08:47 EDTHEBHemispherx extends strategic alliance with Armada Health Care
Hemispherx Biopharma announced that as the company works toward the re-launch of Alferon N, it has extended its agreement with Armada Health Care for two years, through August 14, 2017, for the sales/marketing of Alferon N Injection, its FDA approved natural interferon, in the U.S. Under this Agreement, the Company will manufacture and supply Alferon N Injection to physicians and patients through Armada's national network of specialty pharmacies. Armada has agreed to provide ongoing sales and marketing to support the product's re-launch. Specialty Distributor, BioRidge Pharma, has received a two year contract extension and will warehouse, ship, and distribute Alferon N Injection on an exclusive basis for U.S. sales.

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