Adventrx Submits NDA

San Diego’s Adventrx Pharmaceuticals (NYSE Amex: [[ticker:ANX]]) says it has submitted a new drug application to the U.S. Food and Drug Administration for its reformulated anti-cancer drug vinorelbine injectable emulsion, (Exelbine). The FDA refused to accept the biotech’s first application after Adventrx sprang back to life in January. In a statement this morning, Adventrx CEO Brian Culley says the revised submission addresses concerns the FDA raised about its vinorelbine production by including “12 months of site-specific stability data from our intended commercial manufacturer.” Culley says Adventrx expects the application will be accepted for review in early 2011, “and we look forward to working with the Agency toward our first product approval.”

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.