Vaxess Technologies today announced positive interim results from a first-in-human trial of its influenza vaccine patch. Cambridge, Massachusetts-based Vaxess evaluated VX-103, a monovalent seasonal influenza vaccine patch. The trial included 45 healthy patients and evaluated the H1N1 influenza antigen from Vaxess’ partner, GC Biopharma. Delivery of the vaccine took place through the Vaxess Mimix patch. […]
Drug-Device Combinations
FDA accepts NDA for over-the-counter Narcan nasal spray from Emergent BioSolutions
Emergent BioSolutions (NYSE:EBS) recently announced that the FDA accepted for review its over-the-counter Narcan (naloxone HCI) nasal spray. The FDA last week accepted Emergent’s supplemental new drug application (sNDA) for the Narcan opioid overdose emergency treatment. It also granted the application priority review. If approved, it would represent the first 4 mg naloxone nasal spray […]
Evonik invests in Allay Therapeutics to reduce need for opioids
Evonik announced today that it invested in Allay Therapeutics and its implant for treating pain after knee surgery. Inserted directly into the knee, the Allay implant may relieve pain for up to three weeks, according to a news release. Previous solutions worked for a maximum of three days, the company said. The technology helps promote […]
Tandem Diabetes Care to acquire patch pump maker AMF Medical
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it acquired AMF Medical, maker of the Sigi patch pump for insulin delivery. Switzerland-based AMF Medical currently develops the Sigi patch pump and does not offer it commercially. The system received FDA breakthrough device designation just over one year ago. AMF Medical designed Sigi as an ergonomic, rechargeable […]
Health Canada licenses Medtronic extended-wear infusion set for insulin delivery
Medtronic (NYSE:MDT) Canada announced that Health Canada licensed its Medtronic Extended infusion set for insulin pumps. The Medtronic Extended Infusion Set is the first and only infusion set labeled for a wear time of up to seven days. The infusion set for delivering insulin from a pump to the body typically requires changing every two […]
Dexcom partners with Green Shield, Health Depot on digital diabetes management service
Dexcom (Nasdaq:DXCM) announced today that it partnered with Green Shield and The Health Depot to expand access to the Dexcom G6. The partnership offers Green Shield plan members convenient access to the G6 real-time continuous glucose monitor (rtCGM). It combines this access with virtual diabetes coaching support. Green Shield plan members eligible for G6 coverage […]
Boston Scientific to acquire majority stake in interventional tech developer Acotec
Boston Scientific (NYSE:BSX) announced that it intends to make a partial offer to acquire a majority stake in Acotec. Marlborough, Massachusetts-based Boston Scientific’s offer could add up to a maximum of 65% of Acotec’s shares. Its proposed price totals HK$20 per share. That amounts to approximately $523 million for the 65% stake at current exchange […]
Smiths Medical issues urgent device correction for some CADD infusion pumps
Smiths Medical today issued an urgent medical device correction letter to inform customers of potential issues with its CADD infusion system. The company — which ICU Medical acquired in January for $2.35 billion — identified two potential issues with the infusion sets. They relate to the potential lack of delivery or underdelivery and false no […]
NIH funds Illinois Tech project using machine learning to fully automate insulin delivery
Researchers at Illinois Institute of Technology received $1.2 million from the NIH to develop a machine learning system for an artificial pancreas’ insulin delivery. Chemical engineering professor Ali Cinar leads the project to ease the burden on those with type 1 diabetes. NIH funding covers four years for developing the machine learning system. The researchers […]
Eli Lilly discontinues Ypsomed collaboration to pursue its own U.S. insulin pump offering
Ypsomed announced today that Eli Lilly (NYSE:LLY) elected to stop their joint project to enter the U.S. insulin pump market. In November 2020, the companies entered into a commercialization agreement. The agreement entailed registering and commercializing Ypsomed’s YpsoPump under Lilly’s branding in the U.S. Ypsomed said that, over the past two years, it customized its […]
