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CEL-SCI has submitted a Phase III clinical trial protocol to the FDA for the
use of its investigational immunotherapy drug Multikine in the treatment of
advanced primary squamous cell carcinoma of the oral cavity.
Insmed has submitted a new drug application to the FDA for regulatory approval
of SomatoKine for the treatment of growth hormone insensitivity syndrome.
BioBalance, a wholly owned subsidiary of New York Health Care, has submitted
an investigational new drug application with the FDA to seek approval to conduct
clinical trials of its proprietary biotherapeutic agent, Probactrix, in patients
suffering from pouchitis.
SuperGen has withdrawn its new drug application (NDA) for Orathecin capsules
based on feedback indicating that the current data package would not be sufficient
to gain approval for Orathecin (rubitecan) in the U.S. at this time.
Study results published in the Dec. 30, 2004, issue of The New England
Journal of Medicine show that the drug Macugen is an effective and well-tolerated
treatment for neovascular, or "wet," age-related macular degeneration
(AMD).
Hemispherx Biopharma has announced that its partner Esteve Laboratorios, Spain,
initiated a clinical program to evaluate the antiretroviral effect of Ampligen
in the treatment of patients infected by HIV-1 (with or without co-infection
by the hepatitis C virus) and virological failure with a randomized pilot
study in Phase II, controlled with standard treatment.
Telik has completed enrollment for the ASSIST-1 clinical trial of Telcyta (TLK286),
and initiated a new randomized Phase III trial of Telcyta called ASSIST-3, in
second-line platinum refractory or resistant ovarian cancer.
DOR BioPharma has announced the top-line results of its multicenter, pivotal
Phase III clinical trial of orBec (oral beclomethasone dipropionate) for the
treatment of intestinal Graft-versus-Host Disease (iGVHD).