MedinCell announced that its long-acting injectable malaria treatment is ready to enter into the stages of regulatory development. Montpellier, France–based MedinCell conducted an in vivo proof of concept on cattle that demonstrated three-month mosquitocidal effectiveness in the injectable, long-acting formulation of Ivermectin using the company’s BEPO delivery technology. Get the full story at our sister site, […]
Drug-Device Combinations
Cardinal Health wins new FDA approval for Lymphoseek
Cardinal Health (NYSE:CAH) announced today that the FDA approved its Lymphoseek injection for pediatric use. Dublin, Ohio-based Cardinal Health touts Lymphoseek — acquired from Navidea Biopharmaceuticals (NYSE:NAVB) in November 2016 — as the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB). Get the full story at our […]
Glaukos completes enrollment in Phase 3 trials for iDose TR drug-eluting implant
Glaukos (NYSE:GKOS) announced today that it completed enrollment for a Phase 3 clinical program for its iDose TR sustained-release travoprost implant. San Clemente, Calif.–based Glaukos’ iDose TR implant contains a novel formulation of travoprost, a prostaglandin analog used to reduce intraocular pressure (IOP) through a design that continuously releases therapeutic levels of the medication for […]
BD surpasses 2 billion orders for COVID-19 injection devices
BD (NYSE:BDX) announced today that orders for its needles and syringes hit 2 billion amid global COVID-19 vaccination efforts. Franklin Lakes, N.J.-based BD’s latest milestone comes less than six months after the company surpassed 1 million orders for vaccine delivery devices in December 2020. The order total encompasses commitments to governments all over the globe, including the […]
Tandem Diabetes Care touts study results for insulin pump with closed-loop technology
Tandem Diabetes Care (NSDQ:TNDM) today shared real-world data on its t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology. Presenting at the 14th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD), the company touted immediate and sustained improvements in time-in-range (TIR) observed in more than 9,000 people with diabetes using the system for […]
Medtronic touts real-world results for MiniMed 780G insulin pump
Medtronic (NYSE:MDT) today announced positive real-world outcomes for thousands of patients using the MiniMed 780G insulin pump system. Fridley, Minn.-based Medtronic’s MiniMed 780G system automates and personalized the delivery of basal insulin through adjustments every five minutes for 24 hours a day. It includes an advanced algorithm designed to automatically correct highs every five minutes through […]
GM Instruments, Sensonics partner on nasal and oral measurement devices
GM Instruments announced today that it partnered with Sensonics to develop devices for the quantitative assessment of nasal and oral function. The companies tout the first-of-its-kind partnership as a bringing together of sensory and engineering expertise for evaluating and treating nasal and oral diseases. Get the full story at our sister site, Drug Delivery Business News.
FDA accepts resubmitted NDA for Xipere from Clearside Biomedical, Bausch Health
Bausch Health (NYSE:BHC) and Clearside Biomedical (NSDQ:CLSD) announced today that the FDA accepted their resubmitted new drug application for Xipere. Clearside Biomedical designed the investigational Xipere triamcinolone acetonide suprachoroidal injectable suspension therapy with a proposed indication for the treatment of macular edema associated with uveitis. Xipere works with Clearside’s proprietary SCS Microinjector to access the back of the […]
Lyra inks $135M partnership to expand chronic rhinosinusitis treatment in Asia
Lyra Therapeutics (NSDQ:LYRA) announced today that it entered into a strategic partnership with LianBio for its LYR-210 treatment for chronic rhinosinusitis. Watertown, Mass.–based Lyra, which develops the LYR-210 therapeutic to be locally delivered by its proprietary XTreo platform, could receive up to $135 million in total payments through the strategic partnership and exclusive license agreement […]
SEC lawsuit accuses RenovaCare of securities fraud
The biotech RenovaCare (OTCMKTS: RCAR) announced that it has received a civil complaint from the Securities and Exchange Commission (SEC). The SEC accuses Harmel S. Rayat, a controlling shareholder and chair of RenovaCare, of orchestrating a secret promotional campaign to elevate the company’s stock price. The agency claimed that Rayat and RenovaCare worked with the financial publishing […]
Noveome Biotherapeutics inks licensing deal for SipNose drug delivery device
Noveome Biotherapeutics announced that it entered a commercial license agreement to use SipNose’s proprietary drug delivery device. Yokneam, Israel–based SipNose develops its intranasal Cribriform Targeted Device (CT6), which, under the agreement, was licensed to Noveome to deliver the Pittsburgh-based company’s ST266 biologic to the central nervous systems, according to a news release. Get the full story at our […]