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.

Statin therapy benefits high-risk patients with no prior history of CVD

Two separate studies examined the controversial topic of prescribing statins to high-risk elderly patients who do not already have high cholesterol or cardiovascular disease.

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Roche spends $2.7B to acquire biotech company with multiple obesity, diabetes drugs in development

Roche, one of the world’s largest pharmaceutical companies, will gain both oral and injectable assets as a result of this acquisition.

Avidity Biosciences inks drug discovery deal worth up to $2.3B with industry heavyweight

Avidity Biosciences, a San Diego-based biopharmaceutical company, is expanding its ongoing collaboration with Bristol Myers Squibb to identify new cardiovascular therapies.

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New formula could mean diabetes and weight loss drugs such as semaglutide are only needed every 4 months

GLP-1 agonists are often taken as daily or weekly injections. A new delivery system could help make it so those same drugs are only required three times per year.

Bayer ends blood thinner trial early due to lack of efficacy

The Independent Data Monitoring Committee recommended Bayer stop the trial due to the drug's poor performance compared to apixaban.

ADHD medications associated with heightened CVD risk

"Although the effectiveness of ADHD medications has been demonstrated ... concerns remain regarding their potential cardiovascular safety," one research explained.

Gene-editing therapy lowers cholesterol in high-risk heart patients—one dose could potentially last decades

While the therapy has been successfully tested on animals in the past, this study represents the first time it has been used on humans.

A closer look at how weight loss drug semaglutide improves the cardiovascular health of obese patients without diabetes

Novo Nordisk shared initial results from the SELECT trial back in August, but now the full analysis—which includes data from more than 17,000 patients—has been published in The New England Journal of Medicine.

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