Newsletter - August 18, 2022
Can Pediatric Dosing be Extrapolated from Adult Dosing? FDA Suggests Ways
Conducting clinical trials in children is extremely challenging so very few drugs are tested and approved based on pediatric clinical trials. Pediatricians frequently guesstimate dosing for their patients based on subjective assessment of the dosing data approved for adults. However, there might be an FDA-acceptable...Read More
How Expensive is Too Expensive: Gene Therapy Treatment to Test the Waters
At $2.8 million per patient, the recently approved gene therapy treatment from Bluebird Bio is one of the most expensive treatments approved by the FDA. While developers may justify the cost of such treatments, is there an appetite with the payors for covering such treatments? Without coverage practically...Read More
Can Pediatric Dosing be Extrapolated from Adult Dosing? FDA Suggests Ways
Conducting clinical trials in children is extremely challenging so very few drugs are tested and approved based on pediatric clinical trials. Pediatricians frequently guesstimate dosing for their patients based on subjective assessment of the dosing data approved for adults. However, there might be an FDA-acceptable...Read More
How Expensive is Too Expensive: Gene Therapy Treatment to Test the Waters
At $2.8 million per patient, the recently approved gene therapy treatment from Bluebird Bio is one of the most expensive treatments approved by the FDA. While developers may justify the cost of such treatments, is there an appetite with the payors for covering such treatments? Without coverage practically...Read More
