Drugs

FDA Wants Host Cell Protein Immunogenicity Info

FDA has opened a public docket to receive information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins (HCPs). A Federal Register notice says the agency is specifically interested in comments on suitable methods to detect, identify, and quantify HCPs, on achievable residual amounts of HCPs for recombinant peptide products, and on the use of in vitro, in silico (on a computer) immunogenicity assessment of HCPs in a recombinant peptide product. Specific questions raised in the notice for response are:

the lowest and routinely achievable level of total HCPs across well-controlled recombinant peptide manufacturing processes and how they are calculated or established;
the challenges in reducing HCP levels;
the analytical methods currently used to detect, identify, and quantify HCPs in a recombinant peptide product;
the generally achievable percent coverage of the HCP spectrum for an HCP quantification assay;
the qualitative or quantitative characteristics of HCPs associated with a higher likelihood of adverse clinical sequelae; and
the tools currently used or planned for use to compare the potential immunogenicity risk of two products with different HCP profiles.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome