Koru Medical Systems (Nasdaq:KRMD) announced today that it signed a development agreement with a global pharmaceutical company. The agreement is intended for Koru to develop and seek regulatory clearance for a next-generation subcutaneous immunoglobulin (SCIg) therapy infusion system for use with a commercialized drug therapy. It also includes a close collaboration with Schott Pharma. Koru […]
Pharmaceuticals
Fractyl Health announces layoffs as it pivots to gene therapy
Fractyl Health (Nasdaq:GUTS) is cutting nearly a fifth of its workforce as it streamlines resources and shifts focus toward certain therapies. The company, which develops therapies and procedures for treating obesity and type 2 diabetes, said it plans to prioritize its REMAIN-1 pivotal study. This study addresses the demand for an off-ramp to GLP-1 therapies. […]
Analysts say Embecta is ‘heading in the right direction’ following patch pump discontinuation
Analysts called a recent stock sell-off at Embecta (Nasdaq:EMBC) “unwarranted” and believe the company is moving in the right direction despite recent challenges. Late last year, Embecta filed with the state of Massachusetts to confirm a workforce reduction affecting 118 employees. This related to the company’s plans to discontinue its insulin patch pump program and restructure. […]
Ypsomed, BD collab on self-injection systems for high-viscosity biologics
BD (NYSE:BDX) and Ypsomed today announced a strategic collaboration to advance self-injection solutions for high-viscosity biologic drugs. In a joint project, the companies pre-assessed and streamlined the integration of the BD Neopak XtraFlow glass prefillable syringe with the Ypsomed YpsoMate 2.25 auto-injector platform. They aim to address current limitations by enabling the delivery of higher-viscosity […]
BD partners with ten23 health on prefilled syringe manufacturing
BD (NYSE:BDX) announced today that it entered into a collaboration with ten23 health to develop a new way to track prefillable syringes (PFS). ten23 health, a Swiss CDMO, offers drug development, filling and device assembly expertise to contribute to the product offering. It recently entered into a production collaboration with on-body drug delivery device maker […]
ApiJect Systems promotes COO from within
Injection delivery system developer ApiJect announced that it promoted Molly Weaver to the position of chief operating officer. Weaver’s background includes both the pharmaceutical and medical technology markets. Her experience spans strategy, product development and execution across a broad range of industrialization and drug delivery systems. Most recently, Weaver served as chief technology officer at ApiJect. […]
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 […]
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 […]
Fresenius Kabi recalls and removes some Ivenix infusion pump administration sets from market
The FDA issued a notice outlining a serious recall of Ivenix infusion pump administration sets from Fresenius Kabi. This recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type as it may cause serious injury or death. Fresenius Kabi recalled certain lots of the […]
Tandem wins clearance for t:slim X2 pump with Eli Lilly fast-acting insulin in Europe
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it received clearance for the use of rapid-acting insulin with its t:slim X2 pump. The company can now offer its automated insulin delivery (AID) system with Eli Lilly’s Lyumjev (insulin lispro-aabc injection) ultra-rapid-acting insulin in Europe. Previously, the t:slim X2 pump had clearance for use with Humalog and […]
