Johns Hopkins researchers are touting microdevices that can latch onto intestinal mucosa and release drugs into the body. Led by engineering professor David Gracias and gastroenterologist Dr. Florin Selaru, the team of researchers and biomedical engineers designed and tested shape-changing microdevices that they say can mimic the way the parasitic hookworm affixes itself to an […]
Drug-Device Combinations
Medtronic must face infusion pump lawsuit
A federal judge in Missouri has blocked an effort by Medtronic (NYSE:MDT) to dismiss a lawsuit alleging that the failure of one of its infusion pumps caused “severe and permanent injuries.” Plaintiff Carissa Sullivan, who has cerebral palsy and spastic quadriplegia, claims that the SynchroMed II infusion pump she had implanted in 2011 failed in 2015, causing […]
FDA produces list of ‘essential’ devices, drugs for health, military emergencies
The FDA has released a list of essential medical devices, medicines and “medical countermeasures” that the Trump administration ordered the agency to buy domestically to fight the novel coronavirus and future health and military crises. Devices on the list include diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, devices […]
Dexcom down big despite strong Q3, raised guidance
Dexcom (NSDQ:DXCM) shares took a big hit today on third-quarter results that trounced the consensus forecast. Shares of DXCM were down nearly -9% at $346.51 per share in mid-morning trading yesterday. Today, DXCM is trading down -3.2% $338.10. The San Diego-based insulin delivery technology developer posted profits of $72.2 million, or 73¢ per share, on sales […]
What you need to know about analytical testing for drug-device combinations
Pharmaceutical manufacturers need to understand the compatibility and performance of the primary packaging system with both the drug and its delivery system. Jennifer Riter, West Pharmaceutical Services As more pharmaceutical manufacturers develop combination products, they identify new and complex interactions among packaging components and delivery systems. Understanding this interplay is critical to developing a successful […]
Amazon, Onica to support digital health for Teva’s Digihaler
Teva Respiratory (NYSE:TEVA) announced that it is collaborating with Amazon Web Services (AWS) and Onica to build and host its digital health platform. The Teva Pharmaceuticals affiliate’s digital health platform is a cloud-based backend data system designed to support its FDA-approved Digihaler portfolio of breath-actuated digital inhalers and its companion mobile app that tracks inhaler events […]
Abbott touts Xience DES study results
A pair of studies of Abbott’s Xience drug-eluting stent showed no difference between shorter courses of treatment with dual antiplatelet therapy (DAPT) compared with 12 months of DAPT following implantation of the XIENCE drug-eluting stent (DES) in patients who are at a high risk of bleeding. Abbott presented the late-breaking data today at TCT Connect, the […]
Dexcom, Lilly partner on diabetes management for healthcare providers
Eli Lilly (NYSE:LLY) and Dexcom (NSDQ:DXCM) today announced a joint program for U.S. healthcare providers that includes Lilly’s new, rapid-acting Lyumjev mealtime insulin pen and Dexcom G6 continuous glucose monitoring (CGM) systems. The program is designed to help clinicians use data to inform diabetes management, including promoting the benefits of a new mealtime insulin dose, the companies […]
HHS gives Vaxxas $22M to support vaccine patch tech
Vaxxas announced today that it has received a $22 million award from the Biomedical Advanced Research and Development Authority (BARDA) at U.S. HHS to support a clinical study involving the company’s vaccine-delivery patch. The money will mostly pay for a Phase 1 clinical study in which Vaxxas’ high-density micro-array patch (HD-MAP) delivering pandemic influenza vaccine […]
Delcath names new CEO
Delcath Systems (OTC:DCTH) announced that it appointed Gerard Michel as its new CEO, effective yesterday, Oct. 1, 2020. Michel assumed the role yesterday and also was appointed as a Class I director on the company’s board of directors, with that role continuing until the expiry of his term at the company’s 2022 annual meeting of stockholders, […]
