Latest From Brenda Sandburg
Mesoblast’s Cell Therapy For Pediatric GVHD Gets US Panel Green Light Despite FDA's "Substantial Concerns"
Oncologic Drugs Advisory Committee votes 8-2 that data support efficacy of the product, which could be the first mesenchymal stem cell product to clear the agency. FDA's concerns include reliance on a pivotal Phase III single-arm study.
In advisory committee briefing documents, agency also says critical quality attributes of the graft-versus-host disease treatment do not show a relationship with clinical potency and may not ensure control of clinical effectiveness of individual drug product lots.
US FDA’s Peter Marks says companies are not exchanging information about adenoviral factors, which is probably slowing down the field. He describes NIH's plans for a bespoke gene therapy consortium for vector generation and continued efforts for regulatory harmonization.
Under $24m settlement with the California Department of Insurance, AbbVie’s nurse ‘ambassadors’ cannot participate in conversations between patients and insurance companies and must disclose that they are paid by the company.
About 80% of drug sponsors were on track with post approval studies in FY 2017, US Food and Drug Administration notes in its annual report on performance of applicants.
Lawyer asks US FDA to require another trial before licensing Mesoblast’s stem cell therapy for children with SR-aGVHD; Incyte’s Jakafi is only product approved for the indication.