An FDA advisory panel voted that the label for AstraZeneca’s DPP-IV inhibitor Onglyza should reflect heart failure concerns, Medpage Today reported. But panel members noted that the risk may not apply to all Onglyza patients because the clinical trial they examined focused on patients who had a high risk of heart disease.
A government watchdog is examining how much Medicaid is paying for generic drugs. The Department of Health and Human Services’ Office of the Inspector General will review price increases from 2005 to 2014 to assess how price hikes compared to the rate of inflation, The Wall Street Journal reported. The Journal noted that lawmakers in the House and Senate have already proposed bills that would require generic drug manufacturers to increase Medicaid rebates when drug prices grow faster than inflation.
Santhera Pharmaceuticals may take on full marketing responsibilities for its Duchenne muscular dystrophy drug, Catena, in the US. The benefits include longer patent protection and the opportunity to hold on to more revenue, reported Bloomberg News, which noted Santhera has already identified the 20 to 30 hospitals it would target for marketing its rare-disease drug. Santhera told investors it continues to work on its FDA review application.
AstraZeneca’s tremelimumab landed orphan-drug status. The experimental treatment is for malignant mesothelioma, a rare cancer, Reuters reported. AstraZeneca expects to submit the drug for FDA review next year.
Abbott said its new over-the-counter glucose monitor will help patients avoid co-pays. The company said that the new FreeStyle Precision Neo Blood Glucose Monitoring System will cost $22 to $28, and a pack of glucose testing strips will cost between $14 and $17.
