The European Center for Disease Prevention and Control said the number of unusual pediatric hepatitis cases reached 450, double the number reported two weeks earlier.
As the fairness of orphan drug exclusivities is debated in Congress, the U.S. Food and Drug Administration granted Orphan Drug designations to Editas Medicine and Neurocrine Biosciences.
Health authorities around the world are investigating a mysterious increase in severe cases of hepatitis – inflammation of the liver – in young children.
Takeda Pharmaceutical announced positive results from the Phase III SHP643-301 trial of Takhzyro (lanadelumab) in kids ages 2 to <12 years with hereditary angioedema (HAE). The drug is already approved for HAE in people 12 years and older.
Florida’s top health official said on March 7 the state would recommend against the COVID-19 vaccine for healthy children, breaking with guidance from the U.S. Centers for Disease Control and Prevention.
The BA.2 subvariant of Omicron, which appears to be even more transmissible than Omicron, is accounting for more than a third of global COVID-19 cases. In other news, the U.S. Food and Drug Administration placed limits on the use of GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody therapeutic, sotrovimab.
Two doses of the Pfizer Inc. and BioNTech SE COVID-19 vaccine are highly protective against a rare but often serious condition in children that causes organ inflammation weeks after COVID-19 infections, a U.S. Centers for Disease Control and Prevention report said on January 7.
Novartis received the U.S. Food and Drug Administration’s Breakthrough Therapy tag for the company’s experimental medicine iptacopan, which the Swiss drugmaker hopes wins approval to treat the rare blood disorder paroxysmal nocturnal hemoglobinuria.
The U.S. Food and Drug Administration approved Rhythm Pharmaceuticals’ Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients aged 6 years and older with obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency confirmed by genetic testing.
Beckman Coulter will be using a grant from BARDA (the Biomedical Advanced Research and Development Authority, a division of the Dept. of Health and Human Services) to validate the ability of the company’s Monocyte Distribution Width (MDW) hematology biomarker to aid in the rapid detection of a rare but serious complication of Covid-19 affecting children.