Latest news with #PatrickJeukenne
Yahoo
24-07-2025
- Business
- Yahoo
BD announces wearable injector trial for subcutaneous delivery of biologics
Becton, Dickinson and Company (BD) has announced a trial utilising the BD Libertas wearable injector for subcutaneous delivery of biologics. The decision to employ the injector in this first pharmaceutical-sponsored combination product trial comes after positive results from more than 50 pre-clinical and clinical studies carried out by BD. The company noted that a device clinical trial among these studies highlighted the performance, with all subjects indicating their willingness to use the injector if prescribed. BD Pharmaceutical Systems worldwide president Patrick Jeukenne said: "This trial demonstrates BD's commitment to helping pharma companies by advancing large-volume injection science, ensuring therapies are accessible and patient-friendly by offering more efficient and convenient options for biologics. "BD's enhanced testing capabilities acquired through ZebraSci and the proven capabilities of the BD Libertas Wearable Injector technology further position BD as an innovative leader in drug delivery." The prefilled, patient-ready-to-use system is said to support delivery of high-viscosity biologics of up to 50 centipoise. It comes in two volume configurations, 2mL to 5mL and 5mL to 10mL, catering to various therapeutic needs. Additionally, its design features a simple "peel, stick and click" mechanism, eliminating the need for user filling or assembly. The injector also includes a transparent window for monitoring the drug delivery, push-button activation, along with a colour-coded status indicator. The company is currently validating fill-finish and final assembly processes with several contract manufacturing organisations (CMOs) to ensure support for pharmaceutical collaborators from development to commercial-scale production. As a device component intended for drug-device combination products, it is not subject to US Food and Drug Administration (FDA) 510(k) clearance or European Union (EU) CE mark certification. In April 2025, BD secured the 510(k) clearance for the Phasix ST umbilical hernia patch, enabling the product's commercial launch. "BD announces wearable injector trial for subcutaneous delivery of biologics" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
23-07-2025
- Business
- Yahoo
BD Announces First Pharma-Sponsored Clinical Trial Using BD Libertas™ Wearable Injector Technology for Biologic Drugs
FRANKLIN LAKES, N.J., July 23, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announces the first pharma-sponsored combination product clinical trial using the BD Libertas™ Wearable Injector for subcutaneous delivery of complex biologics. The selection of BD Libertas™ Wearable Injector for this pharma-sponsored trial follows successful outcomes from more than 50 BD-conducted pre-clinical and clinical studies, including a device clinical study demonstrating excellent performance with 100% of study participants stating they would likely use the BD Libertas™ Wearable Injector if prescribedi,ii. The pharma-sponsored combination product clinical trial represents a significant advancement in accelerating innovation in drug-device combination products that provide greater flexibility for patients, including potential conversion from infused medications that require patients to travel to a hospital or clinic to more convenient patient care in various settings, including self-injection at home. "This trial demonstrates BD's commitment to helping pharma companies by advancing large-volume injection science, ensuring therapies are accessible and patient friendly by offering more efficient and convenient options for biologics," said Patrick Jeukenne, worldwide president of BD Pharmaceutical Systems. "BD's enhanced testing capabilities acquired through ZebraSci and the proven capabilities of the BD Libertas™ Wearable Injector technology further position BD as an innovative leader in drug delivery." The BD Libertas™ Wearable Injector is an innovative, prefilled, patient ready-to-use drug delivery systemiii designed to enable delivery of complex biologics via subcutaneous injection. The biologics market is expected to grow to more than $670 billioniv by 2030 and for pharmaceutical companies developing these complex drugs, the BD Libertas™ Wearable Injector offers a customizable, patient-centric solution. The BD Libertas™ Wearable Injector: Supports delivery of high-viscosity biologics (up to 50 centipoise), enabling a wide range of subcutaneous therapies Is offered in 2 to 5 mL and 5 to 10 mL configurations providing flexibility for diverse therapeutic requirements Features a fully mechanical, patient ready-to-use design with a simple "peel, stick and click" mechanism, requiring no end-user filling or assemblyiii BD's ongoing validations of fill-finish and final assembly processes with multiple Contract Manufacturing Organizations (CMOs) enable the company to support pharmaceutical partners from development through commercial-scale production. For more information about how BD Libertas™ Wearable Injector is enabling biologic therapy delivery, visit About BD Libertas™ Wearable InjectorBD Libertas™ Wearable Injector is a product in development; some statements are forward looking and are subject to a variety of risks and uncertainties. BD Libertas™ Wearable Injector is a device component intended for drug-device combination products and not subject to FDA 510(k) clearance or separate EU CE mark certification. About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit or connect with us on LinkedIn at X (formerly Twitter) @BDandCo or Instagram @becton_dickinson. Contacts: Media: Investors: Fallon McLoughlin Adam Reiffe BD Corporate Communications BD Investor Relations 201.258.0361 201.847.6927 i Early feasibility clinical study of investigational BD Libertas™ Wearable Injector (WI) evaluated 5ml, non- Newtonian ~8cP subcutaneous placebo injections in 52 healthy adult subjects for functionality, tissue effects, subject tolerability (100mm Visual Analog Scale (VAS)) and acceptability (questionnaires with 5-point Likert or yes /no responses). Tissue effects were measured from WI removal post-injection through 24 hours with calipers (wheals) or graded on a 5-point scale (erythema, bleeding) from 0-none to 4-severe, significant, respectively. Where tissue effects were observed, the majority (>50%) were resolved within 60 minutes and all within 24 hours. Subject pain (100mm VAS) peaked mid-injection (mean 9.1mm, SD 13.4) and rapidly resolved within 30 minutes (mean 0 .4mm, SD 2.6). Subjects found acceptable (Likert agree + strongly agree or yes responses) their peak pain (≥90.2%), injection site appearance (≥92.2% ).ii Woodley, W. D. et al. Clinical Evaluation of an Investigational 5ml Wearable Injector in Healthy Human Subjects. Clin Transl Sci. 2021 May;14(3):859-869. Pharma filled and assemblediv Mordor Intelligence (2025). Biologics Market Size - Industry Report on Share, Growth Trends & Forecasts Analysis (2025 - 2030). 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