US FDA grants approval for Novartis’ Ilaris to treat Periodic Fever Syndromes
Novartis received approval to market its Periodic Fever Syndrome drug Ilaris (cancakinumab). The drug targets the syndrome, and will be used to treat a group of diseases that cause serious recurrent fever and pathogenic inflammation through non-infectious activation of the immune system. Ilaris inhibits Interleukin-1 (IL-1) beta, and is already approved in the US to treat Cryopyrin-Associated Periodic Syndromes (CAPS) and Systemic Juvenile Idiopathic Arthritis (SJIA).
Sanaria receives FDA fast-track designation for malaria vaccine
PfSPZ, the malaria vaccine of Sanaria, has received fast-track designation from the US Food and Drug Administration (FDA).PfSPZ is currently in clinical trials that are intended to finalise an immunisation regimen to be taken forward into pivotal Phase III clinical trials. If successful, the clinical trials provide the necessary data for licensing the vaccine, according to the company.
Sanofi and Regeneron’s next wannabe blockbuster tagged ‘priority’ by Regulators
FDA has accepted the application for atopic dermatitis candidate dupilumab, from Sanofi and Regeneron, and have given it a priority review tag that should hasten its trip to approval. Dupilumab has already shown it can beat out those topical steroids, too. In June, its makers rolled out Phase III data showing that a dupilumab/corticosteroid combo topped steroids alone. analysts see dupilumab generating more than $2.5 billion a year–with some predicting up to $4 billion or $5 billion.
Allele receives NIH grant to develop new antibody therapy for Alzheimer’s disease
Allele Biotechnology and Pharmaceuticals (Allele) has secured a grant from the US National Institutes of Health’s (NIH) National Institute on Aging to develop a new antibody therapy for Alzheimer’s disease. Allele will develop a panel of antibodies that identify this protein, one of which would be used as a therapeutic drug candidate. The antibodies will feature a distinct shape and size, allowing them to pass the blood-brain barrier to reach the critical areas of the brain. Allele researchers also aim to modify and engineer each antibody to enhance its therapeutic potential.