MannKind announced top-level 30-week results from its Phase 4 INHALE-3 study comparing inhaled insulin to traditional delivery methods. The Danbury, Connecticut-based company designed Afrezza, a rapid-acting inhaled human insulin, to improve glycemic control in adults with type 1 diabetes mellitus. The INHALE-3 study looks at Afrezza against usual care. Mannkind defines usual care as multiple […]
Qnovia wins FDA nod for nicotine inhaler as smoking cessation therapy
Qnovia announced that the FDA cleared its investigational new drug (IND) application for the RespiRx smoking cessation inhaler (QN-01). RespiRx, a drug-device combination product, offers inhalable nicotine replacement therapy (NRT) to assist in the quitting of smoking. IND clearance allows Qnovia to initiate a Phase 1 trial in the U.S. to determine the pharmacokinetics, safety, […]
Senseonics, Ascensia launch Eversense 365 year-long CGM in the U.S.
Ascensia Diabetes Care announced today that it launched the Eversense 365 CGM system from Senseonics (NYSE:SENS) in the U.S. Eversense 365, an implantable continuous glucose monitor (CGM), is indicated for people with type 1 and type 2 diabetes aged 18 years and older. Senseonics announced last month that it received FDA clearance for Eversense 365. With […]
Stevanato Group expands large-volume drug delivery offerings
Stevanato Group announced today that it expanded the capacity of its Vertiva on-body device for subcutaneous large-volume drug delivery. The Italy-based company says its Vertiva platform now covers 10mL volumes. It plans to present the latest Vertiva development at CPhI Milan next month. Vertiva features a single-use injection unit (or pod) and a multi-use smart […]
Vivani can begin first-in-human GLP-1 implant trial in Australia following regulatory approval
Vivani Medical (Nasdaq:VANI) today announced that Australian authorities approved a first-in-human clinical trial for its subdermal GLP-1 implant. The LIBERATE-1 trial will evaluate the miniature GLP-1 (exenatide) implant in obese and overweight subjects. This follows FDA approval for an investigational new drug (IND) application for the company’s implant in June. The FDA lifted the clinical hold […]
CereVasc data shows that eShunt could help deliver gene therapies to the central nervous system
CereVasc shared data from a study demonstrating that its eShunt system may help deliver gene therapies to the central nervous system (CNS). eShunt, a minimally invasive system, includes an endovascularly implantable cerebral spinal fluid shunt and delivery components. CereVasc designed the system to enable transvenous-transdural access to the CNS to treat communicating hydrocephalus (CH) without […]
PCI Pharma Services makes $365M investment in drug delivery device manufacturing
PCI Pharma Services announced that it’s investing more than $365 million in infrastructure to support assembly and packaging efforts. The investment supports the clinical- and commercial-scale final assembly and packaging of drug-device combination products utilizing advanced drug delivery systems, with an emphasis on injectable formats. PCI Pharma plans to put its investment toward new and […]
RenovoRx to increase production of RenovoCath catheter delivery system
RenovoRx announced today that it plans to increase the production of its RenovoCath catheter-based delivery system. The Los Altos, California-based company cited increased demand for the delivery of diagnostic and/or therapeutic agents. It signed a new project work order with its principal manufacturing partner, Medical Murray, providing for an expanded relationship. The company looks to […]
Dexcom, Retta, Beyond Type 2 team up to raise glucose awareness
Dexcom (Nasdaq:DXCM) today announced a collaboration to establish National Glucose Awareness Week from Sept. 23-29, 2024. The San Diego-based continuous glucose monitor (CGM) maker aims to close the glucose knowledge gap. In partnership with the nonprofit Beyond Type 2, Dexcom wants to encourage people to take action “to own their glucose health.” According to a […]
Ypsomed reports positive outcomes with automated insulin delivery for maternal health
Ypsomed reports positive outcomes from a large, randomized trial of its closed-loop insulin delivery technology during type 1 diabetes pregnancy. The Switzerland-based company’s AiDAPT study demonstrated that hybrid closed-loop therapy significantly improves maternal glycemic control. Pregnant women with type 1 diabetes used the automated insulin delivery system based on the CamDiab CamAPS FX algorithm in […]
