Teva (NYSE:TEVA) said yesterday that it won EC Marketing Authorization in the European Union for its Ajovy pre-filled syringe injection meant to serve as a prophylaxis for migraines in adults who experience at least four migraine days per month. The Israel-based company said that Ajovy is a humanized monoclonal antibody that binds to the calcitonin gene-related […]
Breath Therapeutics launches Ph3 trial for inhaled liposomal cyclosporine A therapy
Privately-held Breath Therapeutics said today that it kicked off a Phase III clinical program for its liposomal formulation of cyclosporine A for the treatment of bronchiolitis obliterans syndrome. The company’s primary drug candidate, L-CsA-i, is an inhaled therapy delivered via Pari Pharma‘s investigational eFlow nebulizer. The Boston-1 trial is slated to enroll people with BOS […]
Medtronic responds to usability concerns for its MiniMed 670G insulin pump
Medtronic (NYSE:MDT) responded to a study presented this week which highlighted usability concerns with its MiniMed 670G automated insulin pump, writing that the company had “made many enhancements to the system since the study was done which would likely mitigate many of the issues experienced.” Earlier this week, physicians from Boston Children’s Hospital reported that nearly […]
Study examines usability of hybrid closed-loop insulin pump
Data from an 83-person study of Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop insulin pump showed that nearly one-fifth of participants stopped using the device after struggling with the technical demands of the system, researchers reported. Medtronic’s MiniMed 670G device is designed to automatically track and adjust a patient’s blood sugar levels by measuring blood glucose […]
Dyve Bioscience touts proof-of-concept study for transdermal painkiller
Dyve Bioscience this week touted data from a human proof-of-concept pilot study of its transdermal sodium bicarbonate therapy for pain reduction in people with acute gout flare. The study enrolled 24 people with a history of gout. Those in the active treatment group were given lotion containing sodium bicarbonate and menthol, while those in the […]
Novartis launches COPD inhalers in China
Novartis (NYSE:NVS) has launched its Ultibro Breezhaler and Seebri Breezhaler in China for the treatment of chronic obstructive pulmonary disease. The Ultibro Breezhaler system is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide. Seebri Breezhaler is a fixed-dose formulation of glycopyrronium bromide. The inhaled therapies are approved in more than 90 countries, including the U.S. […]
Novocure launches pivotal ovarian cancer trial
Novocure (NSDQ:NVCR) said today that it kicked off a Phase 3 pivotal trial testing its Tumor Treating Fields therapy combined with paclitaxel in people with recurrent, platinum-resistant ovarian cancer. The 540-patient trial has a primary endpoint of overall survival, with secondary endpoints that include progression-free survival, objective response rate, severity and frequency of adverse events and […]
Novo Nordisk seeks FDA nod for oral diabetes pill
Novo Nordisk (NYSE:NVO) said this week that it submitted applications to the FDA for its oral formulation of semaglutide, a once-daily glucagon-like peptide-1 receptor agonist therapy. The company is hoping its pill will be approved as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. Novo Nordisk also […]
Surmodics shares down following FDA’s paclitaxel device update
Surmodics (NSDQ:SRDX) shares fell last week after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices. In an SEC filing, the company said that it’s working with the FDA to clarify how the company should proceed with an ongoing clinical […]
EOFlow wins breakthrough status for wearable closed-loop insulin delivery tech
Korean medtech company EOFlow said last week that it won breakthrough status from the FDA for its closed-loop automated insulin delivery system for people with Type 1 diabetes. The EOPancreas system features a wearable patch, continuous glucose monitoring systems and a closed-loop blood glucose control algorithm. “EOFlow was founded to democratize wearable drug delivery solutions […]
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