The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system. The designation provides Beta Bionics with priority FDA review. It covers all configurations of the device — insulin-only, glucagon-only, and bi-hormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution, according to Boston-based Beta Bionics. […]
Regenxbio pulls trigger on option to license Clearside Biomedical’s SCS Microinjector
Clearside Biomedical (NSDQ:CLSD) said yesterday that Regenxbio (NSDQ:RGNX) exercised its option to license Clearside’s in-office SCS Microinjector for delivering adeno-associated virus (AAV)-based therapeutics in treating wet age-related macular degeneration, diabetic retinopathy and other conditions. The two companies inked the option and licensing deal that they said at the time could be worth more than $130 million on […]
BD launches syringe-autoinjector combo
Becton Dickinson (NYSE:BDX) today announced the launch of the BD Intevia 1mL two-step disposable autoinjector, which combines an autoinjector and pre-fillable syringe in one integrated system. BD Intevia disposable autoinjector is a 2-step push-on-skin device that is designed to effectively and safely inject a variety of drugs of different viscosities up to 35cP and different […]
Haselmeier licenses Axis-D pen injector to Stevanato Group
Haselmeier said today that it entered into an exclusive agreement with Stevanato Group to license the Axis-D pen injector and intellectual property for the development, manufacturing and supply of the device for diabetes care. Haselmeier’s Axis-D auto-injector pen is approved for use by the European Medical Agency and the FDA, among other regulatory bodies. The […]
FDA approves ready-to-use liquid glucagon from Xeris
Xeris Pharmaceuticals (NSDQ:XERS) said yesterday that the FDA has approved its Gvoke glucagon injection for the treatment of hypoglycemia. Gvoke is a ready-to-use, room-temperature, stable liquid glucagon designed to treat severe hypoglycemia in pediatric and adult patients with Type 1 diabetes aged two years old or above. Chicago-based Xeris’ Gvoke may be administered with a pre-filled […]
Medtronic lands reimbursement for MiniMed 670G pump in Germany
Medtronic (NYSE:MDT) said today it has secured reimbursement for its MiniMed 670G insulin pump system from regulators in Germany. The German Federal Association of the Statutory Health Insurances (GKV-SV) granted reimbursement for the smart insulin pump for patients with type 1 diabetes, according to the company. In May, Medtronic released real-world data from more than 8 […]
Clearside Biomedical, Regenxbio ink sales deal for gene therapy microinjector
Clearside Biomedical (NSDQ:CLSD) has agreed to grant Regenxbio (NSDQ:RGNX) the option to an exclusive worldwide license to sell Clearside’s SCS gene therapy microinjector. The option and licensing deal is potentially worth more than $130 million, the companies said. The SCS microinjector is designed to deliver adeno-associated virus (AAV) gene therapies to treat wet age-related macular […]
Enable Injections inks deal with Genentech
Enable Injections said yesterday that it entered a developmental partnership with Genentech for the Enable enFuse device. Cincinnati-based Enable’s enFuse is an on-body drug delivery platform containing a drug transfer system compatible with syringes and vial containers. Currently, the enFuse is being developed for subcutaneous delivery of large volumes potentially rising to 50 mL. The […]
Teva launches generic EpiPen Jr.
Teva (NYSE:TEVA) today announced that its FDA-approved generic EpiPen Jr. auto-injector is available in the U.S. The device wholesales to most retail pharmacies in packs of two for $300, or $150 per pen. Teva’s product is less than half the cost of Mylan’s non-generic EpiPen Jr., which lists at $643.89 per two-pack at Drugs.com. ”We’re […]
Windgap Medical inks deal with Denmark’s ALK for epinephrine auto-injector
Windgap Medical last week announced a strategic partnership with ALK-Abelló to commercialize its epinephrine auto-injector to treat anaphylactic shock. ALK will have exclusive, worldwide sales and distribution rights for the Windgap epinephrine auto-injector through the deal in exchange for technical and sales milestone payments and tiered royalties on net sales in the U.S. The companies […]
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