The Catalent Applied Drug Delivery Institute said today that it inked a deal to work with the dept. of pharmacy practice at Rutgers University in an effort to identify and address the challenges linked to pediatric drug formulation and delivery. The collaboration plans to focus on the development and administration of medicines to children by […]
Pediatrics
Windtree Therapeutics reports Phase II data for inhaled surfactant
Windtree Therapeutics (NSDQ:WINT) reported data today from the 221-patient Phase IIb trial of its aerosolized KL4 surfactant for the treatment of respiratory distress syndrome in premature infants. The Aerosurf trial evaluated aerosolized KL4 surfactant administered to premature infants 28 to 32 weeks gestational age in 2 dose groups with up to 2 repeat doses, compared […]
Bristol-Myers Squibb launches prefilled syringe option for arthritis drug
Bristol-Myers Squibb (NYSE:BMY) launched a subcutaneous administration option for Orencia, a biologic indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients who are at least 2 years old. The prefilled syringe enables physicians, caregivers and patients to administer Orencia at home. Orencia is traditionally administered via IV infusion. “The data supporting this […]
Halo Pharma launches development & manufacturing facility for pediatric drugs
Halo Pharma launched its Pediatic Center of Excellence today to support the development and manufacturing of drugs tailored for pediatric indications. The company said it will use the manufacturing facility to continue working with pharmaceutical companies to develop pediatric dosage forms of already-approved adult drugs. When the FDA requests that a company conduct clinical trials for […]
Artificial pancreas shows promise in pediatric study
A pilot study evaluating an artificial pancreas in children with Type I diabetes found that the device helped kids control their condition, according to researchers at the University of Virginia. The artificial pancreas was developed at the UVA Center for Diabetes Technology and features a smartphone powered by algorithms that wirelessly link to a glucose monitor […]
Bracco Diagnostics wins another FDA nod for Lumason microspheres
Bracco Imaging U.S. subsidiary Bracco Diagnostics said today that it won FDA approval for its Lumason microsphere contrast agent to be used in ultrasonography of the urinary tract in pediatric patients with suspected or known vesicoureteral reflux. “The approval of Lumason for voiding ultrasonography answers an unmet medical need for an effective imaging study to […]
Pediapharm wins Health Canada nod for antibiotic, steroid combo ear drop
Pediapharm Inc. (CVE:PDP) said today that it won regulatory approval from Health Canada for its Otixal eye drop solution for the treatment of acute otitis media with tympanostomy tubes in pediatric patients. The Quebec-based company touts Otixal as the 1st antibiotic and steroid combination ear drop available in single, sterile unit-dose packaging. Otitis media, or […]
Windtree touts inhaled therapy for infants with respiratory distress syndrome
Windtree Therapeutics (NSDQ:WINT) today released data from a phase IIa trial evaluating its inhaled Aerosurf lucinactant designed for premature infants with respiratory distress syndrome. Results from the trial were presented at the 6th International Congress of European Neonatal and Perinatal Societies in Valencia, Spain. Premature babies often lack adequate surfactant – a naturally occurring substance that reduces the surface […]
FDA awards product development grants for rare diseases
The FDA said yesterday that it awarded 21 clinical trial research grants totaling more than $23 million over the next 4 years to stimulate product development for patients with rare diseases. The Orphan Products Clinical Trials Grants Program has awarded more than $370 million to fund more than 590 clinical studies since its creation in […]
Lupin, MonoSol Rx ink licensing deal for pediatric products
Lupin Pharmaceutical (NSE:LUPIN) said last week that it inked a licensing agreement with MonoSol Rx to develop pediatric products using MonoSol’s drug-delivery technology. Warren, N.J.-based MonoSol touts its dissolvable film, PharmaFilm, as a quick-dissolving system that’s easy to administer and masked by taste. The sublingual film is designed to support pediatric populations that often have trouble swallowing […]
