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Alfacell has released an update on the progress of its ongoing randomized, multicenter, Phase IIIb study of its lead anti-cancer drug, Onconase (ranpirnase).
Join FDAnews Thursday, Sept. 7, for "Prepare Now for FDA Enforcement of Drug Pedigree Laws." In this 90-minute interactive audioconference, Eric F. Greenberg, principal attorney for the law firm of Eric F. Greenberg, P.C., tells you what drugs the FDA plans to focus on first, who must comply with the drug pedigree requirements, how the FDA plans to enforce the rule, whether you have to invest in expensive RFID technologies (and what problems RFID can cause) and more. On Sept. 12, join FDAnews for "Complying with New Cardiac Safety Guidelines for Clinical Trials: Best Practices for Conducting QT Tests." In this 90-minute audioconference with Q&A session, Daniel B. Goodman, M.D., director of medical affairs, Covance Cardiac Safety Services, hands you best practices for development and implementation of a reliable, cost-effective QT prolongation trial that meets the FDA's expectations.
The FDA's Health Drugs Advisory Committee has recommended by a majority vote that the data presented by Adeza in its new drug application (NDA) for Gestiva support efficacy in preventing preterm birth prior to 35 weeks, and that overall safety data is adequate and sufficiently reassuring to support marketing approval in women with a history of preterm delivery.
Wyeth has been notified by the FDA that the agency has extended by three months the action date for its review of the new drug application (NDA) for desvenlafaxine succinate extended release for the treatment of major depressive disorder.
The FDA has accepted for review the Hana Biosciences's new drug application (NDA) for Zensana (ondansetron HCI) Oral Spray for the prevention of nausea and vomiting associated with chemotherapy and radiation.
Inovio Biomedical announced that its partner, Tripep, has achieved additional positive preclinical results showing that its ChronVac-C DNA vaccine combined with Inovio's MedPulser DNA delivery system produced a strong immune response against hepatitis C virus in a large animal model.