With the US Food and Drug Administration (FDA) approving an all-time record number of orphan drugs during 2014, the pricing of these treatments is set to come under increased scrutiny.
Research and consulting firm GlobalData says the FDA approved an all-time record number of 17 orphan drugs during 2014. This out of the total of 41 new molecular entities approved by the FDA last year. The report from GlobalData further stated that while the rare disease sector may appear to be increasingly lucrative for pharmaceutical companies, some orphan drug prices have recently reached new unprecedented levels and their affordability has become a significant issue for payers.
Read the full text here.
Telemedicine Considerations When Conducting Decentralized Clinical Trials
January 14th 2025Compliance with state telemedicine requirements is imperative, as not only will most clinical trial sponsors contractually require such compliance, but non-compliance may also subject the practitioner to licensure violations and liability.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.