Vero Biotech announced today that it raised $30 million to support its Genosyl inhaled nitric oxide (iNO) delivery system. The financing comes just days after the company received FDA approval for Genosyl. The third-generation Genosyl delivery system features faster dosing, simpler workflow and operational efficiency. Petrichor, a healthcare-dedicated growth capital provider, led the financing. Atlanta-based […]
Pediatrics
FDA approves next-gen inhaled nitric oxide delivery system from Vero Biotech
Vero Biotech announced that it received FDA approval for its latest-generation tankless inhaled nitric oxide (iNO) delivery system. Atlanta-based Vero Biotech developed its third-generation Genosyl delivery system for respiratory therapists. Its new features include faster dosing, simpler workflow and operational efficiency. The system speeds up dosing with an adaptive sensor and automated cassette activation feature. […]
FDA clears Insulet Omnipod 5 for children two years and older
Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 for individuals aged two years and older with type 1 diabetes. Acton, Massachusetts-based Insulet’s Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals six years of age and older. In June, […]
Insulet’s Omnipod 5 “significantly improves” glycemic outcomes in very young children
Insulet (Nasdaq:PODD) announced data supporting the use of its Omnipod 5 automated insulin delivery system in young children. Acton, Massachusetts–based Insulet’s Omnipod 5 significantly improved time in range and reduced HbA1c in children aged 2 through 5.9 years old with type 1 diabetes over 12 months of use, according to the company. Earlier this year, […]
Abbott to develop biowearable for continuous monitoring of glucose, ketone levels
Abbott (NYSE:ABT) announced today that it is developing a new biowearable for continuously monitoring both glucose and ketone levels. The all-in-one sensor has already garnered FDA breakthrough device designation and will be used in pivotal trials in 2023, with regulatory submissions to follow thereafter. Abbott Park, Illinois-based Abbott said in a news release that the […]
BioMarin wins FDA approval for injection to increase growth in children with dwarfism
BioMarin Pharmaceutical (NSDQ:BMRN) announced today that the FDA granted accelerated approval for its Voxzogo injection. San Rafael, California-based BioMarin’s Voxzogo (vosoritide) injection has an indication to increase linear growth in pediatric patients with achondroplasia (a form of dwarfism) five years of age and older with open epiphysis (growth plates). Continued approval may be contingent upon […]
Dermavant doses first patient in trial of topical cream for atopic dermatitis
Dermavant Sciences announced today that it dosed the first patient in a Phase 3 pivotal study of its atopic dermatitis (AD) treatment. Long Beach, California-based Dermavant’s double-blind, vehicle-controlled pivotal study evaluates tapinarof for the treatment of AD, according to a news release. The company developed tapinarof as an investigational novel, therapeutic aryl hydrocarbon receptor modulating […]
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). The new indication will expand […]
Genentech touts study results for spinal muscular atrophy drug in babies
Genentech today touted two-year data evaluating the use of its Evrysdi therapeutic in infants with symptomatic Type 1 spinal muscular atrophy (SMA). South San Francisco, Calif.-based Genentech’s Firefish Phase 2/3 global study for Evrysdi (risdiplam) in infants between 1-7 months old showed that the orally administered (liquid or feeding tube) therapeutic continued to improve motor […]
Intranasal COVID-19 vaccines could be on the horizon
All of the COVID-19 vaccines authorized to date are delivered via intramuscular injection. But the intranasal vaccines that are now in development could lead to a more diverse vaccine landscape. The company Altimmune (Gaithersburg, Md.) recently launched a Phase 1 clinical trial to test its single-dose adCOVID intranasal vaccine in 180 adult volunteers. Bharat Biotech […]
