Who You Gonna Call?
This article was originally published in RPM Report
Executive Summary
If Adcetris does not reach the market under accelerated approval by Labor Day, it may be because the company’s management team made the wrong call on the morning of July 15.
You may also be interested in...
Translating FDA for Investors: Seattle Genetics Shrugs Off Public Lambasting at ODAC
Actions speak louder than words. That, at least, is how Seattle Genetics urged investors to think about a tongue lashing the company received during an advisory committee review of the cancer agent Adcetris Seattle Genetics may be right on two levels: the practical outcome of the meeting was positive, and the FDA rhetoric may not have been as directly aimed at the sponsor as a warning to all oncology drug developers.
US Price Negotiation Hearing Lays The Groundwork For Future Improvements
The pharma industry is hoping that litigation might end Medicare price negotiation before it begins. But a House hearing also starts the process of developing legislative improvements that might be viable in years to come – starting with trying to restore the lifespan of small molecules.
As Sickle Cell Gene Therapies Move To Market, Health Inequities Could Help Pricing Debate
Positive tandem ICER reviews for bluebird bio’s and Vertex/CRISPR’s gene therapies show the impact that concerns about addressing racial inequities could create a favorable context for products as they enter pricing and coverage discussions.