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.   

healthcare value value-based care money dollar

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. 

pharmaceutical drug approval process

FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

The temporary rock bridge is now allowing access to the Baxter North Cove IV bag plant in North Carolina, which has enabled cleanup crews to begin work on the flooded plant that supplies 60% of U.S. IV bags.

Baxter works to get North Carolina IV plants back online as national shortages loom

Baxter's IV plant in North Carolina was flooded by Hurricane Helene. That plant provides 60% of the U.S. supply of IV bags. 

Medtronic's MiniMed 780 (left) and 670 (right) insulin pumps in FDA recall

FDA rules Medtronic’s insulin pump issues a Class I recall due to safety risks

Some of Medtronic's 600 and 700 series MiniMed insulin pumps are experiencing significant battery issues when dropped, bumped or impacted in any way. This has been linked to reports of health issues in more than 180 patients.

Helene damage to bridge Baxter North Cove facility in North Carolina.

Baxter closes largest IV solution factory, sparking fears of a shortage

Flood damage forced Baxter to close a facility that makes 60% of IV solutions in the U.S., a loss of 1.5 million bags per day. 

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FTC sues drug middlemen over insulin prices, puts others on notice

The FTC alleges that pharmacy benefit managers have set up a system where they get rich, while patients are forced to pay rising insulin costs. The agency also called out drug manufacturers such as Eli Lilly, Sanofi and Novo Nordisk, saying their own actions have raised serious concerns.

Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system

Safety update: Sensor issue with Abbott CGMs ruled a Class I recall

The sensors of certain FreeStyle Libre 3 devices are producing inaccurate glucose readings and should not be used. Two patient injuries have been reported. Abbott first reported the problem in July. 

Brittany Nicole Weber, MD, PhD, Brigham and Women's Hospital, explains the growing role of cardio-rheumatology clinics.

The growing role of cardio-rheumatology clinics

Cardio-rheumatology clinics use a heart team-like approach to enhance care for patients with chronic conditions such as lupus, psoriasis and rheumatoid arthritis. "It's not just about cardiology," the director of one clinic explains. "We work closely with rheumatologists, dermatologists and even primary care physicians to provide comprehensive care."

Around the web

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. 

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. 

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