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.

AI cardiology heart artificial intelligence deep learning

AI could help cardiologists predict bleeding, stroke risks in AFib patients on DOACs

Researchers developed several new AI models that could guide the management of patients with non-valvular atrial fibrillation. There is still some work to do in terms of accuracy, but they already appear to outperform the traditional risk scores being used today.

IV hospital room intravenous drip solution

Tenecteplase compares favorably to alteplase in new comparison of FDA-approved stroke drugs

Researchers explored data from nearly 80,000 patients, comparing the newest clot-busting stroke drug from Genetech with its predecessor.

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.

Deepak L. Bhatt, MD, discusses research and drug therapies in development to treat lipoprotein (a). #Lp(a)

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.

FDA ends semaglutide shortage, closing the door on compounded Wegovy, Ozempic

The years-long shortage of Wegovy and Ozempic, two popular prescription-only semaglutide injections, is officially over.

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