Gene Therapy Trial Designs For Bleeding Disorders Could See Patient Input At FDA Meeting
This article was originally published in The Pink Sheet Daily
During its patient-focused drug development meeting on hemophilia, von Willebrand Disease and other bleeding disorders, the agency will ask patients about how they decide whether to join a clinical trial.
You may also be interested in...
A cautious patient population with long memories could thwart the potential of new hemophilia A treatments, even as the market leaders promise Wall Street that switching patients will be no problem.
Biogen Idec will price its new hemophilia B drug Alprolix on par with older medicines like Pfizer’s Benefix on an annual basis despite the drug’s dosing advantage. The decision comes as high drug prices have come under increased scrutiny from payers and U.S. legislators.
PDUFA V framework to involve patients in the creation of the risk-benefit criteria for various diseases kicks off before the legislation is even enacted.