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.

FDA finalizes new heart warnings for COVID-19 vaccines
The new warnings, first proposed to Pfizer and Moderna in April, are now officially required by the FDA. They provide additional information about the potential risks of myocarditis and/or pericarditis associated with these vaccines.
New report raises questions about data that helped heart drug gain FDA approval
Ticagrelor, an antiplatelet medication from AstraZeneca commonly prescribed by cardiologists, gained FDA approval back in 2011. The author of a new investigative report, however, is raising several concerns about the data used to secure that approval.
Popular obesity drugs limit amputations, heart issues among patients with peripheral artery disease
Semaglutide, tirzepatide and other GLP-1 drugs appear to provide significant value for patients with moderate PAD.
Updated: Dexcom recalls more than 700K CGM receivers over safety issues—dozens of adverse events reported
There is an increased risk that these devices will not provide audible alerts for low or high blood glucose levels. The FDA has ruled that this is a Class I recall, highlighting the safety risks associated with missed alerts.
Eli Lilly to acquire gene-editing specialists focused on CVD for up to $1.3B
The company has agreed to acquire Verve Therapeutics for an upfront payment of approximately $1 billion. The total could increase significantly, however, if certain milestones are met. One of Verve's biggest gene therapies has already received the FDA's fast track designation.

The entrance to the AHA expo and technology floor. #AHA22

American Heart Association announces late-breaking research for Scientific Sessions 2024

The three-day conference begins Saturday, Nov. 16, in Chicago. Topics will include AI, heart failure, patient management and much more.

Cardiologist Sanjit Jolly, MD, MSc, at TCT 2024

Colchicine falls flat in large heart attack trial, convincing cardiologists to stay away

Treating AMI patients with colchicine is not associated with better cardiovascular outcomes, according to new data presented at TCT. The drug did help with inflammation, but that was the only benefit researchers could identify.

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.

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.

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.

Helene damage to bridge Baxter North Cove facility in North Carolina.

Baxter closes largest IV solution factory, sparking fears of a shortage

Flood damage forced Baxter to close a facility that makes 60% of IV solutions in the U.S., a loss of 1.5 million bags per day.

Pharmaceutics

FDA finalizes new heart warnings for COVID-19 vaccines

New report raises questions about data that helped heart drug gain FDA approval

Popular obesity drugs limit amputations, heart issues among patients with peripheral artery disease

Updated: Dexcom recalls more than 700K CGM receivers over safety issues—dozens of adverse events reported

Eli Lilly to acquire gene-editing specialists focused on CVD for up to $1.3B