Drugs

Technical Suggestions on FDA Myeloid Leukemia Guidance

AbbVie says that an FDA draft guidance, Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment, would be most useful if the agency modified it to include instructions on analysis of best/overall response in the presence of post-study treatment. The company comment letter says, for example, the guidance could indicate that data collected after post-study treatment will not be included in the analysis of the best/overall response.

Novartis says FDA should consider adding the Estimand framework and its application to acute myeloid leukemia. The company acknowledges the coordinated approach on defining the elderly and unfit acute myeloid leukemia populations and asks the agency to consider opening the definition to allow alignment of the population with current practice as it is likely to evolve as more knowledge is available and additional treatments become available.

Both AbbVie and Novartis provided specific comments in addition to their general recommendations. Specific technical comments also were submitted by Regeneron, Pfizer, Otsuka, and Janssen.

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