Firm plans to begin Phase III studies of nolatraxed for treatment of unresectable hepatocellular carcinoma as early as September following receipt of "Fast Track" designation from FDA. The company expects the trials to last through 2002, with a U.S. NDA filing possible by the end of 2002. Zarix licensed Thymitaq from Agouron in 1998 (1"The Pink Sheet" Jan. 18, 1998, p. 24)
You may also be interested in...
The Irish biopharmaceutical firm Zarix will develop Agouron's oncologic agent Thymitaq (nolatrexed) worldwide as the first step in its strategy of introducing U.S. biotech products to European markets.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials