Pharmaceutics

This page contains key pharmaceutical news on drug recalls, FDA clearance, safety communications and research. In cardiology, key pharmaceutic agents include antiplatelet therapies, anticoagulants, hypertension drugs, and drugs for heart failure and arrhythmias.   

pharmaceutical drug approval process

FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

The temporary rock bridge is now allowing access to the Baxter North Cove IV bag plant in North Carolina, which has enabled cleanup crews to begin work on the flooded plant that supplies 60% of U.S. IV bags.

Baxter works to get North Carolina IV plants back online as national shortages loom

Baxter's IV plant in North Carolina was flooded by Hurricane Helene. That plant provides 60% of the U.S. supply of IV bags. 

money business cash flow dollar

AstraZeneca spends up to $1.9B for new heart disease drug

Early data suggest the drug, an oral lipoprotein (a) disruptor, could make a significant impact on patient care. AstraZeneca will pay $100 million upfront, with much more to follow if certain milestones are met. 

Medtronic's MiniMed 780 (left) and 670 (right) insulin pumps in FDA recall

FDA rules Medtronic’s insulin pump issues a Class I recall due to safety risks

Some of Medtronic's 600 and 700 series MiniMed insulin pumps are experiencing significant battery issues when dropped, bumped or impacted in any way. This has been linked to reports of health issues in more than 180 patients.

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Following heart failure guidelines could save 1.2 million lives per year

Millions of heart failure patients who qualify for standard medical therapies do not receive treatment due to poor health literacy, limited access to care and medication costs.

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It’s not what you eat, but when: Intermittent fasting boosts heart health of high-risk patients

“Unlike expensive pharmaceuticals like Ozempic, which require lifetime use, time-restricted eating is a simple lifestyle change that does not cause side effects and can be maintained indefinitely,” one doctor explained. 

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FTC sues drug middlemen over insulin prices, puts others on notice

The FTC alleges that pharmacy benefit managers have set up a system where they get rich, while patients are forced to pay rising insulin costs. The agency also called out drug manufacturers such as Eli Lilly, Sanofi and Novo Nordisk, saying their own actions have raised serious concerns.

Harlan Krumholz, MD, SM, editor-in-chief of the Journal of the American College of Cardiology (JACC), and a cardiologist and the Harold H. Hines, Jr. Professor of Medicine at the Yale school Medicine, explains some of the key technology advances he is watching across cardiology.

JACC editor excited by progress during a 'very important moment' for cardiology

Harlan Krumholz, MD, editor-in-chief of the Journal of the American College of Cardiology, explains some of the key technology and treatment trends he has his eyes on.

Around the web

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

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