Drugs

CDER into Bispecific Antibody Research, Application

FDA says CDER staff have been conducting research to analyze different bispecific antibody (BsAb) molecular formats using physiochemical and biological approaches. An online paper says the studies are not intended to develop drugs, but rather to understand how different forms of BsAbs affect quality aspects such as product characterization, bioassay or potency assay development, and stability.

BsAbs are next-generation monoclonal antibodies, the paper says, and their development has been revolutionized over the last two decades due to genetic engineering approaches that enable a wide variety of molecular structures that offer different advantages and disadvantages.

Most BsAbs in development aim to treat cancer, FDA says, but others are focused on chronic inflammatory, autoimmune, and neurodegenerative diseases; vascular, ocular, and hematologic disorders and infections.

“Research and development efforts are leading to clinical applications,” the paper says. “There are over 100 BsAbs in clinical development, most in the early stages. Since 2014, FDA has approved nine BsAb marketing applications to treat cancer, as well as hematologic and ocular diseases. In the future, FDA anticipates there will be a spectrum of BsAbs developed to prevent, treat, or diagnose diseases.”

The paper concludes that there is likely to be more research, development, and clinical applications of BsAbs, as well as the development of multispecific antibodies that can target multiple antigens simultaneously.

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