Top news of the day across the health care landscape.
On Thursday, officials with the FDA declined to grant accelerated approval to sacituzumab, Immunomedics’ cancer treatment for breast cancer, Reuters reported. According to the article, Michael Pehl, CEO of Immunomedics, stated that the issues related to the approval were focused on chemistry, manufacturing, and control matters. The company said it will request a meeting with the FDA to work closely with the agency to launch the treatment as soon as possible, the article reported.
An FDA advisory panel was split on whether to recommend approval for Sanofi and Lexicon’s treatment for type 1 diabetes, Reuters reported. According to the article, the panel voted 8-8 when asked to assess sotagliflozin, which is a once-daily, oral medication as an add-on to insulin therapy. Although the drug showed efficacy in clinical trials, FDA officials flagged the risk of diabetic ketoacidosis, the article reported.
A new CDC study indicates a possible link between opioid use and a rare birth defect that appears to be on the rise in the United States, the Associated Press reported. According to the article, the study found that the birth defect, called gastroschisis, was 60% more common in US counties that had the highest overall opioid prescription rates. The findings do not say whether opioids caused the birth defect, but the researchers did suggest the need for further study of a possible connection, the article reported.