Drug Delivery Business
2023年9月6日 · Stevanato Group expands large-volume drug delivery offerings. Sean Whooley. 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.
SpyGlass shares positive data for drug-eluting intraocular lens
6 小时之前 · SpyGlass Pharma released 18-month follow-up data highlighting the potential of its intraocular lens (IOL)-based drug delivery platform. Data came from a first-in-human study of 23 patients with glaucoma or ocular hypertension. They received the IOL implant at the time of cataract surgery. The company reported a consistent sustained reduction of ...
8 drug delivery innovations you should know
2023年7月20日 · Innovations in drug delivery never stop, and over the past 12 months or so a wide variety have been in the spotlight. Constant progress continues in the diabetes space, both in the form of insulin delivery and other drug delivery methods. Elsewhere, we see implants, patches, syringes and more showcasing the many ways we can deliver therapeutics.
FDA approves next-gen drug delivery system from Medtronic
October 10, 2023 By Sean Whooley. The SynchroMed III system. [Image courtesy of Medtronic] Medtronic (NYSE:MDT) announced today that the FDA approved its next-generation SynchroMed III intrathecal drug delivery system. The medtech giant designed SynchroMed III to treat patients with chronic pain, cancer pain and severe spasticity.
Medtronic wins FDA nod for next-gen Simplera CGM - Drug …
2024年8月7日 · The company won CE mark for Simplera with InPen last September. It then picked up CE mark for Simplera Sync with MiniMed 780G this year. Both launched earlier this year, with Medtronic reporting positive feedback around ease of use and insertion. Medtronic said FDA approval “lays the groundwork” for a future submission for the updated InPen ...
Eyenovia begins manufacturing next-gen drug delivery system
2024年10月3日 · [Image courtesy of Eyenovia] Eyenovia (Nasdaq:EYEN) announced that it began manufacturing batches of its Mydcombi product for its next-generation delivery platform. Manufacturing registration batches of the FDA-approved Mydcombi mydriasis product marks a key step in the approval process for the company’s state-of-the-art Gen-2 Optejet dispensing platform, according to a news release.
FDA clears Dexcom G7 next-gen CGM - Drug Delivery Business
2022年12月8日 · Dexcom (Nasdaq:DXCM) announced today that the FDA cleared the next-generation Dexcom G7 continuous glucose monitoring (CGM) system. FDA clearance for the highly anticipated device covers people with all types of diabetes aged 2 years and older. San Diego-based Dexcom’s device features a 60% size reduction from the previous generation, the G6.
BD partners with ten23 health on prefilled syringe manufacturing
October 7, 2024 By Sean Whooley. 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.
Dexcom raises guidance ahead of G7 launch, FDA submission …
2021年10月29日 · Dexcom said it expects to post full-year 2021 revenues ranging between $2.425 billion and $2.45 billion. “We are pleased to once again be in a position to raise our full-year revenue and margin guidance as we drive toward a strong conclusion of 2021 and the upcoming launch of our Dexcom G7 system,” Sayer said in the release.
Regulatory/Compliance Archives - Drug Delivery Business
2024年10月4日 · 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.