Drugs

FDA Breakthrough Rescission on Protagonist’s Rusfertide

FDA has told Protagonist Therapeutics that it intends to rescind the company’s breakthrough therapy designation for rusfertide and its use in treating polycythemia vera. In an updated company slide presentation, the agency attributed its rescission decision to “observed malignancies, in follow-up to the FDA clinical hold imposed on 9/16/2021,” according to the company.

The clinical hold was quickly lifted on 10/11/2021 (see earlier story). The hold followed notification to FDA about a recent non-clinical finding in a 26-week rasH2 transgenic mouse model study, the company said at the time. “The rasH2 model is designed to detect signals related to tumorigenicity, and benign and malignant subcutaneous skin tumors were observed in this study,” it said.

The company says it has submitted a response on the breakthrough rescission and requested a meeting. It notes that its orphan drug and fast track designations remain in place. Protagonist anticipates no changes to its development plans for rusfertide, including no anticipated changes to timelines for the Phase 3 VERIFY study in polycythemia vera.

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