Drugs

Orphan Status for Experimental Myelofibrosis Therapy

FDA has granted Opna Bio an orphan drug designation for its investigational treatment OPN-2853 (zavabresib), a small-molecule bromodomain and extra-terminal motif inhibitor, for myelofibrosis, which is characterized by progressive scarring of the bone marrow and leading to impaired blood cell production and symptoms that can include severe fatigue, anemia, and enlargement of the spleen.

Zavabresib is currently being evaluated in an investigator-sponsored Phase 1 study known as PROMise, which is being conducted at the University of Oxford in collaboration with Cancer Research UK. The study focuses on patients whose disease is no longer adequately controlled by ruxolitinib alone. Data presented last month at the American Society of Hematology showed that 16 of 26 evaluable patients experienced a reduction in spleen length of at least 50% compared with baseline when treated with the therapy, according to the company.

Company executives said they have held recent discussions with FDA and plan to continue evaluating zavabresib in additional clinical studies as development progresses.

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