Drugs

Orphan Status for Sickle Cell Disease Drug

FDA has granted Kind Pharmaceutical an orphan drug designation for AND017 and its use in treating sickle cell disease (SCD). The company says the preclinical work supporting AND017's designation will be presented in a future scientific meeting and published in a scientific journal.

Hydroxyurea and L-glutamine are the limited FDA-approved oral treatments for SCD, and Kind says it believes AND017 might not only provide a novel oral treatment with unique mechanism of action, but also a superior safety and efficacy profile.

AND017 is described as a first-in-class hemoglobin elevating agent that targets multiple stages of the red blood cell life cycle. It is also being developed to treat anemia associated with dialysis-dependent chronic kidney disease, non-dialysis dependent chronic kidney disease, and cancer-related anemia.

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