Novartis Zometa
Executive Summary
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 Aredia Follow-On Zometa Priority Goal Date Set For June
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.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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