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 first new clot-dissolving drug for ischemic stroke in decades
Tenecteplase is a tissue plasminogen activator given to patients through a single five-second intravenous bolus. It is only the second drug of its kind to gain FDA approval, and the first in many years.
Cardiologists recommend complete revascularization, intravascular imaging in new ACS guidelines
The American College of Cardiology and American Heart Association published the new guidelines with assistance from other leading U.S. medical societies.
FDA sued over ‘reckless and arbitrary’ semaglutide decision
The Outsourcing Facilities Association, a Texas-based trade group, is alleging that supply issues still remain for Ozempic and Wegovy. The group believes the FDA has ignored those issues.
Medtronic enrolls first patient in new coronary DCB trial—data could lead to FDA approval
The paclitaxel-coated device, already approved in Europe and other parts of the world, will be tested on more than 1,200 patients for a new international trial. If the study is a success, Medtronic hopes to gain regulatory approval in the United States and Japan.
New drug therapies targeting Lp(a) could be a breakthrough in cardiovascular care
Lipoprotein (a) research is on the rise in recent years. Deepak Bhatt, MD, director of Mount Sinai Fuster Heart Hospital, explains why this trend is so important.

New U.S. guidelines on chronic coronary disease rethink use of beta-blockers, other medications

The updated recommendations from the American College of Cardiology and American Heart Association cover a variety of topics, including patient communication, follow-up imaging, nutritional supplements and more.

Eli Lilly to acquire private equity-backed drugmaker for up to $1.9B

Versanis, founded in 2021 by a venture capital firm, is primarily known as the company behind the obesity drug bimagrumab.

Roosha Parikh, MD, advanced imaging cardiologist, St. Francis Heart Hospital, Long Island, New York, and a clinical assistant professor of medicine at the State University of New York at Stony Brook, presented in one of the ASE 2023 amyloid sessions and spoke with Cardiovascular Business about the disease.

Amyloidosis now a hot topic in cardiac imaging due to new drug treatment

Advanced cardiac imager Roosha Parikh, MD, explained that cardiac amyloidosis is regularly misdiagnosed. It can often be identified in echocardiography results, however, if physicians know how to identify it.

dipyridamole injection drug shortage heart imaging Canada

‘I have no dose for anyone right now’: Drug shortage hits cardiologists in Canada, leading to delays

“It's very important,” one cardiologist said. “This is a life-saving test and it's very frustrating that we can't access the medication.”

PHOTO GALLERY: The trends and technologies at ASE 2023

Browse through some of the many highlights from the American Society of Echocardiography's 2023 annual meeting.

Donislecel Lantidra FDA type 1 diabetes severe hypoglycemia

FDA approves first cellular therapy to treat type 1 diabetes

The new therapy, made from the pancreatic cells of deceased donors, is designed to help adult type 1 diabetes with severe hypoglycemia go a year or longer without needing to take insulin.

Colchicine Lodoco Agepha Pharma price cost

What will Lodoco cost? Looking ahead after FDA’s historic approval of colchicine for CVD

“Our pricing strategy for Lodoco is focused on helping to ensure access to as many people as possible,” an executive with Agepha Pharma told Cardiovascular Business.

The U.S. Food and Drug Administration (FDA) priority review, the FDA has cleared the Agepha Pharma USA LLC's drug Lodoco (colchicine) as the first anti-inflammatory atheroprotective cardiovascular treatment.

Cardiologists applaud FDA’s approval of colchicine for CVD

"The FDA's approval of colchicine confirms that we are entering a new era of patient care," said one veteran cardiologist familiar with the drug.

Pharmaceutics

FDA approves first new clot-dissolving drug for ischemic stroke in decades

Cardiologists recommend complete revascularization, intravascular imaging in new ACS guidelines

FDA sued over ‘reckless and arbitrary’ semaglutide decision

Medtronic enrolls first patient in new coronary DCB trial—data could lead to FDA approval

New drug therapies targeting Lp(a) could be a breakthrough in cardiovascular care