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 approves Bayer's finerenone to treat wide range of heart failure patients
Finerenone, sold by Bayer under the brand name Kerendia, is now approved in the United States for the treatment of HFmrEF and HFpEF. The drug has already been used for years to treat patients with chronic kidney disease and type 2 diabetes.
Statin use may protect patients from subarachnoid hemorrhages
Statins appear to be the most impactful for patients diagnosed with hypertension or cerebrovascular disease.
FDA grants breakthrough therapy designation to new drug candidate for FA cardiomyopathy
The new drug, LX2006, has already received the FDA's fast track designation. This latest distinction was based on early data from two separate clinical trials.
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.

FDA approves drug for children with rare condition causing high LDL cholesterol

Evkeeza, which was previously approved for patients ages 12 and above, was shown to help lower cholesterol for children with homozygous familial hypercholesterolemia (HoFH), in conjunction with other therapies.

NASA astronaut Kate Rubins conducts research for the Effect of Microgravity on Drug Responses Using Engineered Heart Tissues (Cardinal Heart) investigation onboard the International Space Station, one of several cardiovascular experiments on the ISS in recent years. Two more cardiac experiements launched to the ISS in March 2023. NASA Image

Heart tissue heads to space for research on aging and impact of long spaceflights

These experiments, performed with help from NASA, are simply out of this world.

Blood thinner recalled due to potential cancer risk

The recall, announced by the FDA, includes multiple lots of dabigatran etexilate capsules.

Steven Nissen, MD, chief academic officer of the Heart, Vascular and Thoracic Institute, Cleveland Clinic, explains the details from the late-breaking CLEAR Outcomes trial presented at the 2023 American College of Cardiology (ACC) meeting found bempedoic acid can be used in statin-intolerant patients to reduce low-density lipoprotein (LDL) cholesterol levels. #ACC #ACC23 Nexletol

CLEAR Outcomes trial shows statin-intolerant patients benefit from bempedoic acid

Steven Nissen, MD, spoke with Cardiovascular Business at ACC.23 about the late-breaking CLEAR Outcomes trial.

Links to all the American College of Cardiology late-breaking studies for ACC.23

Here are links to more information on every late-breaking presentation at ACC.23.

ACC 2023 program chair Douglas Drachman, MD, explains the top takeaways from the American College of Cardiology meeting. #ACC #ACC23

Key takeaways from the ACC 2023 annual meeting

ACC.23 Program Chair Doug Drachman, MD, explains what he saw as some of the key takeaways from the American College of Cardiology (ACC) 2023 annual meeting.

Valentin Fuster, MD, PhD, director of Mount Sinai Heart and general director of the Spanish National Center for Cardiovascular Research

High dosage of blood thinners lowers 30-day morbidity for hospitalized COVID-19 patients

For patients who were hospitalized, but not yet in the ICU, those randomly assigned a higher-dose of anticoagulants had lower 30-day mortality risk than those on a lower dose.

Large study finds high rates of nonadherence to statin recommendations; women especially averse

Many patients who would clearly benefit by lowered LDL cholesterol levels are choosing to forgo first-time recommendations for statin regimens, according to a population-level study.

Pharmaceutics

FDA approves Bayer's finerenone to treat wide range of heart failure patients

Statin use may protect patients from subarachnoid hemorrhages

FDA grants breakthrough therapy designation to new drug candidate for FA cardiomyopathy

FDA finalizes new heart warnings for COVID-19 vaccines

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