Tags : Children

Sanofi Reports Results of Dupixent (dupilumab) in P-III LIBERTY ASTHMA

Shots: The P-III LIBERTY ASTHMA VOYAGE study involves assessing of Dupixent (SC, 100/200mg, q2w ) + SOC maintenance therapy of medium-dose ICS with a second controller medication/ high-dose ICS with/out second controller medication vs PBO in 408 children 6 to <12 years old with uncontrolled moderate-severe asthma Results: Patients with baseline blood EOS ≥300 cells/μl […]Read More

BioMarin Reports NDA Submission to the US FDA for Vosoritide

Shots: BioMarin has submitted an NDA to the US FDA for vosoritide to treat children with achondroplasia The company also reported that EMA has begun validation of MAA for the therapy on 13 Aug, 2020 Vosoritide is an investigational, once-daily injection analog of C-type Natriuretic Peptide (CNP) and is potentially the first treatment for achondroplasia […]Read More

BioMarin Reports the Submission of MAA to EMA for Vosoritide

Shots: The MAA is based on P-III study assessing the efficacy and safety of vosoritide, further supported by the long-term safety and efficacy from the ongoing P-II and P-III extension studies and extensive natural history data Following the completion of EMA’s validation, BioMarin expects the initiation of the MAA review to commence in Aug’2020. The […]Read More

Akili’s EndeavorRx Receives the US FDA’s Approval as the First

Shots: The FDA’s De novo clearance is based on five clinical studies in 600+ children diagnosed with ADHD, which demonstrated an improved measure of attention. After 4wks., one-third of children had no longer measurable attention deficit on at least one measure of objective attention Change in child’s day-to-day impairments following @1mos. treatment with EndeavorRx which […]Read More