Lilly Forteo launch
Lilly expects to launch the osteoporosis drug Forteo "at the end of this year or early next year, depending on the timing of...approval in the fourth quarter," Exec VP August Watanabe tells analysts at Banc of America Securities Conference Sept. 10. In July, FDA's Endocrinologic & Metabolic Drugs Advisory Committee recommended the drug for the treatment of osteoporosis in postmenopausal women but said the indication should be restricted to high-risk patients and second-line use (1"The Pink Sheet" July 30, p. 3)
You may also be interested in...
Lilly's Forteo should be approved for treatment of osteoporosis in postmenopausal women but restricted either to high-risk patients or second-line use, FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended July 27.
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