Teva Pharmaceuticals (NYSE:TEVA) announced the U.S. launch of the first generic version of the twice-daily Perforomist inhalation solution. Parsippany, N.J.-based Teva Pharmaceuticals — a U.S. affiliate of Tel Aviv, Israel-based Teva Pharmaceutical Industries Ltd. — launched the formoterol fumarate inhalation solution (20 mcg/2 mL) with an indication for treating bronchoconstriction in patients with chronic obstructive pulmonary […]
Drug-Device Combinations
Pear Therapeutics to go public via SPAC merger
Prescription digital therapeutics pioneer Pear Therapeutics announced today that it will go public by merging with a SPAC called Thimble Point Acquisition Corp. Boston-based Pear Therapeutics’ combination with the special purpose acquisition company (SPAC), whose management team is associated with the Pritzker Vlock Family Office, will result in a combined company named Pear Holdings Corp. […]
Smiths Medical recalls some insulin syringes over skewed graduation marking
Smiths Medical announced today that it issued recall notices for its Jelco Hypodermic Needle-Pro fixed needle insulin syringes. Minneapolis-based Smiths Medical became aware of specific models and lots of the Jelco Hypodermic Needle-Pro fixed needle syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. The company identified markings skewed upward […]
MedinCell to begin regulatory development of long-acting injectable malaria treatment
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, […]
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 […]
