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Brenda Sandburg

New York, NY
Brenda Sandburg is a senior writer who covers legal issues and FDA regulatory policy, with a particular focus on patents, biosimilars, and government investigations. She spent 10 years writing for legal publications between stints at The Pink Sheet and blends these experiences to provide in-depth analysis of events. An aspiring photographer, she enjoys taking photos to accompany news stories.

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.

Advisory Committees Drug Approval Standards

US FDA Questions Adequacy Of Mesoblast’s Remestemcel-L Single-Arm Study For Pediatric GVHD

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.

Advisory Committees Drug Review

Gene Therapy Manufacturing Hurdle: Sponsors Unwilling To Share ‘Secret Sauce’

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.

Gene Therapy Manufacturing

Unlikely Foe Gets AbbVie To Alter Humira Marketing Practices In California

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. 

Advertising, Marketing & Sales Legal Issues

Sponsors Staying On Schedule With Postmarketing Requirements And Commitments

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.

Post Market Regulation & Studies Clinical Trials

Ahead Of Ryoncil’s Advisory Committee, Citizen Petition Opposes Approval For Pediatric GVHD

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.

Advisory Committees Drug Approval Standards
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