Hana Biosciences and NovaDel Pharma have decided to file a different formulation of Zensana with the FDA after running into manufacturing problems with the therapy recently. A European version of Zensana, an oral spray designed to treat the side effects of cancer treatments, will be submitted to the FDA next year. In addition, Hana announced that it was dropping its bid for a Special Protocol Assessment for Marqibo following the FDA's decision to limit SPA's to randomized trials. Hana's shares fell about 20 percent in premarket trading.
- check out the press release for more
- here's the AP report on the regulatory moves