A pricing chart for Abbott's HIV therapy Norvir (ritonavir) misrepresents the dose and cost of therapy, a June 10 FDA 1warning letter states. The chart compares "a subtherapeutic dose of Norvir (100 mg once daily) to the labeled dosing regimens of other antiretroviral agents," FDA said. "The cost chart is false or misleading...because it claims that Norvir has the lowest daily cost of all antiretroviral drugs and minimizes the risks of Norvir." NIH is considering compulsory licensing for Norvir (2"The Pink Sheet" May 31, 2004, p. 3)...

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