FDA rejects Zarnestra -- for now

As expected, the FDA has formally rejected Johnson & Johnson's Zarnestra for acute myeloid leukemia. Given the FDA advisory council's decision last month that one Phase II trial provided insufficient evidence to back the application, that ruling had been factored in by most analysts. J&J was looking for an FDA approval to use the drug on seniors who were not good candidates for chemotherapy. J&J said it isn't discouraged by the rejection, though. The company says it is "committed" to Zarnestra and is studying the FDA's response to determine what its next step will be.

- read this story from TheStreet.com for more

Suggested Articles

The public financing will enable Monopar to start a phase 3 trial of a prophylactic treatment for a side effect of chemoradiotherapy. 

The dispute centers on whether Asa Abeliovich used Alector’s confidential information in connection with his work for Prevail Therapeutics.

GSK poaches Merck KGaA's Martinez-Davis to helm pharma stateside; Bulto named Novartis U.S. pharma head; Allergan's Saunders set for huge parachute.