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Janssen 2 articles

Janssen fights to dismiss Invokana lawsuit filed in PA state court

A Texas man has filed a lawsuit against Johnson & Johnson’s Janssen Pharmaceuticals in Philadelphia state court over claims that the company’s type 2 diabetes medication Invokana caused him to develop life threatening diabetic ketoacidosis. But the drug company contends that the man’s lawsuit should be thrown out because it has no business being in Philadelphia County. Matthew Landes’ lawsuit is one of 41 filed in the Court of Common Pleas in Philadelphia County involving the alleged Invokana side effect of ketoacidosis, and one of 39 filed by people who don’t live anywhere near the county. The drug company argued that ... Read More

FDA requests more data on diabetes drug candidate combining Invokana with metformin

The Food and Drug Administration (FDA) wants more clinical trial data on Janssen’s new type 2 diabetes treatment that combines the recently approved Invokana (canagliflozin) with the widely used metformin, before it will decide whether to approve the new combination therapy. The agency requested more information comparing the twice-daily combination pill with the once-daily canagliflozin. Janssen, a Johnson & Johnson company, says it has the data the agency needs from its comprehensive Phase 3 clinical development program for the drug. Canagliflozin was approved by the FDA in March 2013. It is the first approved drug in a new class of ... Read More