FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year

For over 50 years, Novartis has developed innovative medicines to treat cardiovascular disease. Building on this legacy, I am reaching out to share the news that Novartis received approval from the U.S. Food and Drug Administration (FDA) for Leqvio® (inclisiran), the first and only small interfering RNA (siRNA) to provide effective and sustained reduction in low-density lipid cholesterol (LDL-C), commonly referred to as “bad cholesterol,” as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of LDL-C. The effect of Leqvio on cardiovascular morbidity and mortality has not yet been determined but is being explored in clinical trials currently underway.

The United States spends over $125 billion on direct medical expenses for ASCVD care each year, and heart disease and stroke represent the largest medical expenditures in the country. Beyond direct healthcare costs, heart disease and stroke have been estimated to result in $138 billion annually in lost productivity.

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2022 – Focused on the Year Ahead

2021 was a challenging year in many ways.  It was also a year when AZBio Members stepped up to meet these challenges.  As we look forward to 2022, we are focused on AZBio’s vision of Arizona becoming a top-ten bioscience state.  We  invite you to learn more about how you can get engaged with  AZBio in 2022 and participate in focus initiatives designed to move us toward the top-ten. Continue reading

Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19

Dec 22. 2021 – Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Continue reading

The MedTech Conference Plans to Return to Boston in 2022 with a Strong In-Person Presence

WASHINGTON, D.C. – The MedTech Conference, powered by the Advanced Medical Technology Association (AdvaMed), announced today it will return to Boston from October 24-26, 2022, with hopes of reconvening the industry after two unconventional years. The annual three-day event provides world-class programming, networking, and business development opportunities for the global medical technology community. The conference will once again offer options for virtual attendance while encouraging safe in-person participation.

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