Drugs

Comments on Therapeutic Protein Guidance

The Biotechnology Innovation Organization (BIO) says an FDA draft guidance on a drug-drug interaction assessment for therapeutic proteins provides helpful information to sponsors regarding assessing such interactions. “The opportunity for sponsors to consider the specifics of their particular therapeutic proteins in the context of specific indications and concomitant medications and propose a fit-for-purpose development strategy in consultation with the agency is appreciated,” the comment letter says.

BIO suggests that the guidance include a discussion on the potential of generalizing information between ADCs (antibody-drug conjugates) that share the same payload. “It would be helpful to understand, from FDA’s perspective, under what conditions it would be possible to apply information from a drug-drug interaction study conducted using an ADC to another ADC that had the same payload,” BIO says. The association also gives specific line-by-line comments.

A Pfizer comment letter quotes and expands upon the BIO general comments and gives specific comments.

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