Pink Sheet Podcast: Medicare Inflation Rebates And Negotiation, Leqembi Reimbursement, US FDA Gene Therapy Chief
Executive Summary
Pink Sheet reporter and editors discuss the first round of mandated Medicare inflation rebates and new guidance on price negotiations, consider the VA’s decision to cover the Alzheimer’s drug Leqembi, and the US FDA continuing to search for a cell and gene therapy office leader.
You may also be interested in...
340B Program Spending Continues To Swell In 2022, Topping $53bn
Stakeholders differ on whether the rapid growth in spending is to be expected, given the realities in health care and specialty drug costs, or that the data underscores the need for oversight and reform of the 340B program.
US FDA’s Standard Application Assessment Makes A Comeback
After years where many more applications received priority assessments than standard assessments, in FY 2022 the difference narrowed.
Gene Therapy: Nonclinical Questions Do Not Seem Ideal For The US FDA’s New Type D Meeting
Nonclinical testing questions should be answered in a pre-IND meeting, rather than the new Type D session. A US FDA Center for Biologics Evaluation and Research official also indicated support for alternatives to animal testing when possible.