August 4, 2023

Janssen submits supplemental new drug application to FDA seeking expanded pediatric indication for HIV-1 therapy Edurant

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of Edurant (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more. A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support […]

admin Health 0 1 min read
July 2, 2023

CHMP positive for Mircera to treat paediatric patients with anaemia associated with CKD – Roche

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mircera (methoxypolyethylene glycolepoetin beta). The marketing authorisation holder for this medicinal product is Roche Registration GmbH. The CHMP adopted an extension to an existing indication for use in paediatric patients. For information, the […]

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June 19, 2023

Bayer starts phase II/III study with vericiguat in children with heart failure

Bayer and its development partner MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA) announced that the first patient has been enrolled in the Phase II/III VALOR trial. VALOR will investigate the efficacy, afety, and pharmacokinetics of vericiguat (Verquvo) in pediatric patients aged greater than 28 days to 18 years with heart failure due to left ventricular systolic […]

admin Health 0 1 min read
June 15, 2023

European Commission approval for Pedmarqsi to reduce the risk of hearing loss in paediatric oncology patients – Fennec Pharma

Fennec Pharmaceuticals Inc.has announced Pedmarqsi– known as Pedmark in the U.S. – was granted marketing authorization by the European Commission. Pedmarqsi is the first and only approved therapy in the EU for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to less than 18 years of age with localised, non-metastatic, solid tumors. Further, Pedmarqsi […]

admin Health 0 2 min read
June 1, 2023

How to diagnose and manage depression in adolescents: a new review for clinicians

How do you diagnose and manage depression in adolescents? A new review published in CMAJ (Canadian Medical Association Journal) https://www.cmaj.ca/lookup/doi/10.1503/cmaj.220966 aims to help primary care clinicians address this increasingly common, yet under-detected condition, in teenagers. “Although more than 40% of people with depression experience onset before adulthood, depression remains undetected in many adolescents in Canada, and most are untreated,” writes Dr. Daphne Korczak, a psychiatrist […]

admin Health 0 1 min read
May 30, 2023

Survey: Nearly 7 in 10 parents believe social media image editing apps and filters have a negative influence on their children’s body image

With children more plugged in to social media than ever before, a wave of new image editing apps and filters along with trends related to appearance have parents concerned about damage to body image. According to a new national survey conducted online by The Harris Poll on behalf of The On Our Sleeves Movement For Children’s Mental Health, 69% of parents […]

admin Health 0 2 min read
May 27, 2023

Skin patch shows promise for toddlers with peanut allergy

A global phase 3 clinical trial that included Ann & Robert H. Lurie Children’s Hospital of Chicago found that a year-long immunotherapy through a skin patch safely desensitized toddlers with peanut allergy, lowering the risk of a severe allergic reaction from accidental exposure. Results of this randomized, double-blind, placebo-controlled trial for children 1-3 years of age, funded by DBV Technologies, […]

admin Health 0 1 min read
May 21, 2023

New analysis of trial of semaglutide in adolescents shows it can reduce liver enzymes indicative of liver damage

A new substudy of the STEP TEENS trial presented at this year’s European Congress on Obesity (ECO 2023, Dublin 17-20 May) shows that adolescents using semaglutide experienced significant reductions in levels of liver enzymes that are an indicator of liver damage. The study is by Dr Daniel Weghuber, Department of Pediatrics, Paracelsus Medical University, Salzburg, Austria, and Dr Rasmus Sørrig, […]

admin Health 0 2 min read
April 10, 2023

Survey of family physicians identifies gaps in primary care’s behavioral health integration

Survey of Family Physicians Identifies Gaps in Primary Care’s Behavioral Health Integration Researchers from the American Board of Family Medicine (ABFM) and the University of Washington in Seattle examined the characteristics of family physicians who work collaboratively with behavioral health professionals (BHP). Prior evidence has demonstrated that integrating behavioral health into primary care can improve access to mental health care […]

admin Health 0 1 min read
April 1, 2023

Limit screen use in children under six, says psychologist

“Children who are in regular contact with mobile phone screens, tablets or computers are more irritable and have worse attention, memory and concentration than those who do not use them.” Parents should strictly ration or not allow screen time for children aged under six, according to a leading neuropsychologist in a new book. Dr Álvaro Bilbao, Ph.D., uses current and established […]

admin Health 0 2 min read

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