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An innovator files a CP raising scientific or regulatory concerns about a competitors pending approval questions about bioequivalence methodology, manufacturing controls, formulation characterization, or potential safety signals

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That high discontinuation rate makes it especially important to understand what happens to weight and health risks related to diabetes and heart disease once treatment is discontinued

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The objective was to evaluate the effectiveness and safety, with a specific focus on cardiovascular safety, of tirzepatide, a novel dual GIP and GLP-1 receptor agonist, compared to insulin glargine in adults with type 2 diabetes and a high risk of cardiovascular events who have not achieved adequate control with oral glucose-lowering medications.This phase 3 study was conducted at 187 sites across 14 countries on five continents

Nausea is a separate, temporary side effect during dose adjustment that typically resolves