EMPA-REG Data Will Boost Jardiance's Role In Combination Therapy, Lilly Says
Large outcomes trial showing a cardiovascular benefit with empagliflozin could shift the treatment landscape to earlier use of the SGLT2 inhibitor in combination therapy rather than replacing treatment with metformin and other agents, Lilly Diabetes President Conterno predicts.
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FAERS reports identify cases of diabetic ketoacidosis, ordinarily rare in type 2 diabetes, which were not associated with high blood sugar levels.
Agency leader expects to spend about a year developing a strategy to combat misinformation. On 5 August, the agency unveiled what appears to be an early component of the initiative – a web page titled Rumor Control, with facts about the safety and components of COVID-19 vaccines.
Switching method of administration from subcutaneous to intradermal would increase by five-fold the number of doses of Bavarian Nordic’s vaccine available to combat the outbreak; an EUA declaration would be needed to make this change, FDA commissioner Robert Califf said.