Studies are ongoing for bisphosphonate zolendronate in postmenopausal osteoporosis and corticosteroid-induced osteoporosis and are planned in osteogenesis imperfecta, Novartis said. Zometa is receiving FDA fast-track review for tumor-induced hypercalcemia, with a June 21 user-fee goal date (1"The Pink Sheet" Feb. 14, p. 22)
You may also be interested in...
Novartis' bisphosphanate Zometa will receive a priority FDA review for treatment of tumor-induced hypercalcemia. The fast-track review has an estimated user-fee goal date of June 21.
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