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 […]
Pediatrics
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 […]
FDA clears once-daily ADHD capsule from Corium
Corium (NSDQ:CORI) announced today that it received FDA approval for its once-daily Azstarys oral capsule for treating ADHD symptoms. Boston-based Corium touts its Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) drug as the first and only product containing a d-MPH oral prodrug for treating ADHD (attention deficit hyperactivity disorder) symptoms in patients aged six years and older, […]
FDA approves Medtronic MiniMed 770G insulin pump for young children
(Image courtesy of Medtronic) The FDA has approved the Medtronic (NYSE:MDT) MiniMed 770G hybrid closed loop-diabetes management system for Type 1 diabetes patients aged 2 to 6 years. The MiniMed 770G is the first-of-its-kind system that can automatically adjust insulin delivery based on continuous glucose monitor values for for such young children, according to the agency. The FDA […]
Tandem Diabetes Care wins expanded FDA indication for insulin pump
Tandem Diabetes Care (NSDQ:TNDM) announced today that it won an expanded pediatric indication from the FDA for its t:slim X2 insulin pump. The t:slim X2 with Control-IQ technology won FDA clearance for controlling Type 1 diabetes in December, which was followed by a commercial launch in the U.S. the next month. Tandem touts t:slim X2 with […]
Smith & Nephew acquires Tusker Medical
Smith & Nephew (NYSE:SNN) today said it acquired Tusker Medical for an undisclosed amount. Tusker Medical develops the Tula System, which is an in-office ear tube delivery system to treat recurrent or persistent ear infections. The pediatric ear tubes won FDA breakthrough device designation in November last year. “The Tula System is a truly innovative option for physicians […]
Tusker Medical’s pediatric ear tubes land breakthrough device designation
The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of […]
Teva launches generic EpiPen Jr.
Teva (NYSE:TEVA) today announced that its FDA-approved generic EpiPen Jr. auto-injector is available in the U.S. The device wholesales to most retail pharmacies in packs of two for $300, or $150 per pen. Teva’s product is less than half the cost of Mylan’s non-generic EpiPen Jr., which lists at $643.89 per two-pack at Drugs.com. ”We’re […]
BD recalls SmartSite syringe administration set
Becton Dickinson (NYSE:BDX) recalled nearly 3,000 leaky SmartSite syringe administration sets used in the neonatal intensive care unit in what the FDA deemed a Class I action. Franklin Lakes, N.J.-based BD issued an urgent medical device recall in February involving 2,900 of its SmartSite syringe administration sets, which are used with infusion pumps to deliver medication, […]
ETV/CPC show positive outcomes in babies with hydrocephalus
Hydrocephalus, literally “water on the brain,” is an abnormal build-up of cerebrospinal fluid in the brain cavities known as ventricles. In infants, it can be congenital (it often accompanies spina bifida, for example), or it can be caused by brain hemorrhage or infection. The usual treatment is surgery to implant a shunt, which drains the […]
