Biologics

Mpox Product Development Guidance

FDA has released a draft guidance entitled “Mpox: Development of Drugs and Biological Products.” The document provides nonclinical, virology, and clinical considerations for mpox drug development programs, and it includes recommendations to support initiation of clinical trials.

The guidance notes that preventive vaccines are not addressed in the document because these “raise different and additional considerations, including those pertaining to subject selection, safety monitoring, and effectiveness evaluation.” Additionally, it recommends that sponsors seeking initial advice for mpox drug development submit a pre-investigational new drug application (pre-IND) meeting request.

It says that for sponsors looking to begin a clinical trial for a small molecule drug, the following should be provided:

Data from good laboratory practice compliant general toxicology studies in two species (at least one nonrodent)
An assessment of standard safety pharmacology parameters (e.g., cardiovascular, respiratory, and central nervous system assessments), which may be incorporated into general toxicology studies
The standard battery of genetic toxicology data

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