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.   

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Insulet Corporation, a Massachusetts-based medical device company focused on diabetes technology, announced that its Omnipod 5 Automated Insulin Delivery System is now cleared by the U.S. Food and Drug Administration (FDA) to manage type 2 diabetes (T2D).

FDA clears first automated insulin pump for type 2 diabetes

Insulet's Omnipod 5 Automated Insulin Delivery System was already cleared to help patients manage type 1 diabetes. 

Medicare coverage for weight loss drug semaglutide could cost up to $145B per year

Medications that target obesity are not typically covered by Medicare. When the FDA approved semaglutide as a way to treat certain cardiovascular risks, however, CMS said Medicare coverage was on the table. 

pharmaceutical drug approval process

Drugmaker to ‘challenge’ FDA after only receiving tentative approval for inhaled PAH treatment

An exclusivity agreement is stopping Liquidia Corporation from gaining full FDA approval of its new inhalation powder for pulmonary arterial hypertension. The company said it is disappointed with the agency's decision and plans to "take quick action."

Bharath Krishnamurthy, a director of Health Policy and Analytics at the American Hospital Association (AHA), explains explains how drug shortages and supply chain issues are negatively impacting U.S. healthcare.

Drug shortages jeopardize patient access to quality hospital care

American Hospital Association Director of Health Policy and Analytics Bharath Krishnamurthy explains how drug shortages and supply chain issues are negatively impacting U.S. healthcare.

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White House unveils lower prices for popular heart, diabetes drugs after Medicare negotiations

Apixaban, empagliflozin, rivaroxaban and sacubitril/valsartan are just some of the medications included in this initial round of Medicare price negotiations. Their new prices were reduced by 56%, 66%, 62% and 53%, respectively. 

Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.

Patient risks persist for insulin pump caught in Class I recall

A software update for the pump's mobile app was expected to fix ongoing battery issues, but the problem remains. 

Novo Nordisk withdraws FDA application to expand use of weight loss drug

The Danish pharmaceutical company said it will resubmit its application in 2025 to have Wegovy approved for use in heart failure patients.

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Medtronic and Abbott join forces to develop new diabetes tech

Medtronic and Abbott are often seen as rivals in a competitive marketplace, but the two companies are collaborating with a simple goal in mind: improving patient access to high-quality CGM devices. 

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Around the web

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met. 

AI in Healthcare
Healthcare AI regulation needs nuance, balance: Research review

When regulating AI-equipped medical devices, the FDA might take a page from the Department of Transportation’s playbook for overseeing AI-equipped vehicles. These run the gamut from assisting human drivers to fully taking the wheel. 

Radiology Business
Pending radiology bills in Congress and predicting the Trump administration's impact on imaging

Kit Crancer, RBMA board member, speaks with Radiology Business about key legislative developments on the Hill that will affect the specialty.