Biologics

FDA Accepts Theratechnologies BLA for HIV-1

FDA has accepted for review a Theratechnologies BLA for ibalizumab as a treatment for multidrug resistant human immunodeficiency virus-1. The company says that, if approved, ibalizumab will be the first antiretroviral treatment with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing. The agency has set a user fee review action target date of 1/3/2018.

The submission is based on data from the Phase III TMB-301 study, a single arm, 24-week study of ibalizumab plus an optimized background regimen in treatment-experienced patients who had high pre-existing levels of drug resistance and advanced clinical disease. The humanized monoclonal antibody works by binding to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites, the company says. “It potentially prevents HIV from infecting CD4-positive immune cells while preserving normal immunological function,” it adds.

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