Supplemental NDA filed June 3 for secondary progressive multiple sclerosis indication. Immunex is requesting a priority review. Novantrone (mitoxantrone) reduced by 21% the relapse rate and disability progression in 194 patients with secondary progressive multiple sclerosis, according to results of a two-year pivotal trial. Third-year follow-up results demonstrated sustained reduction. Novantrone is approved for treatment of pain in patients with advanced hormone-refractory prostate cancer and for initial therapy of acute non-lymphocytic leukemia
You may also be interested in...
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
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth