Phillips-Medisize said today that it entered into an agreement with an unnamed biotechnology company to manufacture a wearable, electronic-enabled combination product for subcutaneous drug delivery. The hockey puck-sized product is designed as a disposable, single-use combination device that can be worn near the infusion site for two days or adhere to the patient’s body with […]
West Pharmaceutical Services launches NovaPure drug-delivery system
West Pharmaceutical Services (NYSE:WST) said today that it’s launching the NovaPure 3mL cartridge components with its NovaPure product line for delivery of higher-volume injectable drug-delivery systems. The Exton, Pa.-based company also announced that its SmartDose Gen. II 10mL injector for subcutaneous drug delivery is available for commercialization as well. West’s NovaPure portfolio currently includes stoppers and […]
Clearside Biomedical confirms timeline for Xipere
Clearside Biomedical (NSDQ:CLSD) last week said that the FDA found no efficacy issues with its Xipere drug-delivery technology and will not ask for further clinical efficacy studies. The Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. In October 2018, Clearside touted data from a Phase III pivotal trial, which reported […]
Concept Medical wins CE Mark for MagicTouch DCBs
Concept Medical said yesterday that it received CE Mark approval for three versions of its MagicTouch sirolimus-coated balloons. The MagicTouch PTA for peripheral artery disease, MagicTouch ED for erectile dysfunction and MagicTouch AVF for arterio-venous fistula and graft all received approval in Europe, according to a news release. Concept Medical said MagicTouch PTA is the […]
Novartis unit spikes Pear Therapeutics deal
Novartis (NYSE:NVS) unit Sandoz said this week that Pear Therapeutics will take sole responsibility for the commercialization of their prescription digital therapeutics program for treating substance and opioid use disorders. In April 2018, Pear announced that it agreed to deal commercialization rights of its digital therapeutics to Sandoz. The companies did not disclose financial details, but […]
NIH study: Tandem Diabetes artificial pancreas bests other treatments
A pivotal trial funded by the National Institutes of Health found that an artificial pancreas system from Tandem Diabetes Care (NSDQ:TNDM) was more effective than existing treatments for people with Type 1 diabetes. The Tandem system combines its t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology with a continuous glucose monitor made by DXCM, […]
Gates Foundation backs Credence MedSystem’s drug-delivery device
Credence MedSystems said yesterday that it won a grant from the Bill & Melinda Gates Foundation for the development of its Companion dual-chamber reconstitution syringe for use in developing nations. The development project is meant to advance the safety of the Companion device for drug and vaccine products, which include storing drugs in dried form […]
Senseonics touts Eversense reimbursement win
Senseonics (NYSE:SENS) said this week that Health Care Service Corporation – Blue Cross Blue Shield is providing coverage for the Eversense continuous glucose monitoring system, effective as of yesterday. HCSC – Blue Cross Blue Shield is the fourth-largest health insurer in the U.S. and serves more than 16 million members, according to a news release. Last […]
FDA approves Philips’ low-dose Stellarex balloons
Royal Philips (NYSE:PHG) said today that two of the company’s new Stellarex drug-coated balloons received FDA approval for the treatment of upper leg artery blockages. The approval was for both de novo and restenotic lesions in upper leg arteries. The Amsterdam-based company said the new low-dose (200 mm and 150 mm) balloons will be added to […]
Intarcia Therapeutics takes another run at FDA approval
Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type 2 diabetes mellitus. The Boston-based company originally resubmitted the NDA on Sept. 9. FDA told the company that it considered the NDA resubmission a complete class 2 response. The Prescription Drug User Fee […]
