Secondary Endpoints, Post Hoc Data May Be “Sweet Spot” For Payers
Executive Summary
ATLANTA - Companies should look for the types of clinical trial data which may not be sufficient alone for FDA approval, but could be persuasive to payers making coverage determinations, Schering-Plough's David S. Sugano suggests
You may also be interested in...
OrBec Future In Doubt: Cmte. Calls For Further Study, But Firm Is Out Of Funds
With FDA's Oncologic Drugs Advisory Committee one set of concluding that another clinical trial is necessary to prove a benefit of DOR BioPharma's orBec, the graft-versus-host disease drug may have reached the end of the road as the company says it does not have the funding for an additional trial
Flawed Junovan Trial Design Leads Committee To Doubt Efficacy Results
Problems in clinical trial design for IDM Pharma's osteosarcoma drug Junovan (mifamurtide) could have been rectified if the sponsor had held an end-of-Phase II meeting with FDA prior to study initiation, the agency said in briefing documents for a May 9 meeting of the Oncologic Drugs Advisory Committee
IFRA Hosts Capitol Hill Scent Experience In Timeout From Policy Concerns
The International Fragrance Association North America took a break from its higher-stakes advocacy work Nov. 1 to give lawmakers and congressional staffers a "scent experience." Perfumers from six of the group's biggest members were on hand with "Scents of Home," joined by Monell Center researchers to educate attendees on the mechanics of scent and the important role it plays in people's lives.