The FDA has classified the recall of Medtronic’s (NYSE:MDT) SynchroMed II implantable drug pumps as Class I, the most serious type of recall. The company announced the voluntary recall in October, saying that it had received complaints about the pumps’ motors stalling permanently. Permanent motor stall could prevent the infusion of drugs to the patient, […]
Drug-Device Combinations
Lilly to integrate DexCom CGMs in automated dosing system
Eli Lilly (NYSE:LLY) announced that it will integrate Dexcom (NSDQ:DXCM) products into its personalized diabetes management system, now under development. Under the new, non-exclusive agreement, Indianapolis-based Lilly will use San Diego-based Dexcom’s continuous glucose monitoring (CGM) devices in pen-based and pump-based platforms in Lily’s diabetes management system. The pen-based platform is designed to integrate personalized data from […]
Dyve Biosciences wins FDA nod for Phase 2 transdermal drug delivery trial
Dyve Biosciences received FDA clearance to begin a Phase 2 study of its DYV-700 transdermal therapeutic for the treatment of acute gout pain. Thousand Oaks, Calif.-based Dyve said it plans to begin the Targets study in the first quarter of 2020. It is slated to be a double-blind, placebo-controlled, randomized clinical trial to evaluate the […]
3M to sell drug-delivery biz to Altaris Capital Partners for $650m
3M (NYSE:MMM) announced today that it entered into an agreement to sell most of its drug-delivery business to an affiliate of Altaris Capital Partners for approximately $650 million. St. Paul, Minn.-based 3M will retain its transdermal drug delivery components business, according to a news release. The business being divested has annual global sales reaching approximately […]
Eitan Group signs service agreement with Integrated Medical Systems
The Eitan Group this week said it signed a service partnership with integrated Medical Systems. Through the agreement, Integrated medical Systems will be the service provider for the Eitan Group’s Sapphire infusion pumps that are used in hospital-based and alternate site infusion. Get the full story on our sister site, Drug Delivery Business.
Drug or device? FDA loses this argument for now
This article has been updated with comments from an attorney for Genus Medical Technologies. A federal judge has temporarily blocked an attempt by the FDA to regulate a barium sulfate product ingested before imaging as a drug. The decision counts as at least a partial win for Genus Medical Technologies (St. Louis), maker of the […]
Aptar wins FDA clearance for ready-to-use seizure treatment device
AptarGroup today said it won FDA approval for its Unidose Liquid System that treats acute repetitive seizures in people who have epilepsy. The Unidose Liquid System is a device that delivers a nasal rescue treatment that is ready-to-use when and where a seizure cluster occurs. Get the full story on our sister site, Drug Delivery Business […]
Report: 3M may sell off its drug-delivery business for $1 billion
3M (NYSE:MMM) may try to sell off its drug-delivery business in a deal that could fetch $1 billion, according to a report by Bloomberg. The drug delivery division makes transdermal drug patches, microneedle delivery systems, nasal devices, oral inhalers and packaging films for drug delivery. 3M is also developing a smart inhaler and is looking for pharmaceutical […]
W.L. Gore officials think they can spur insulin delivery system innovation
W.L. Gore announced this week that it is investing in PhysioLogic Devices, a startup developing an implantable intraperitoneal insulin delivery system. The size of the investment was not disclosed. But it was part of Gore’s Micro-Equity Investment (MEI) program, which provides investments of up to $500,000. W.L. Gore officials think the company’s more than 60 years […]
Leo Pharma, Portal Instruments partner to develop needle-free drug delivery device
Leo Pharma and Portal Instruments this week announced a global collaboration and license agreement to develop a needle-free drug delivery system. Through the agreement, Leo Pharma’s investigational and approved medicines will be used in combination with Portal’s needle-free drug delivery system. Portal’s needle-free jet injector platform allows patients to self-administer biologics without needles. Get the full story on […]
CSA Medical wins CE Mark approval for RejuvenAir System
CSA Medical announced this week that it won CE Mark approval for its RejuvenAir system for treating chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB). The RejuvenAir system that is designed to apply spray-liquid nitrogen at -196◦C in a circumferential pattern to central airways through a minimally invasive bronchoscopic procedure, freezing damaged surface area […]