Drugs

Attralus Gets Orphan Status for Imaging Agent

FDA has granted Attralus an orphan drug designation for 124 I-AT-01 iodine (evuzamitide) as a diagnostic for managing transthyretin amyloidosis (ATTR). The company says the product utilizes its pan-amyloid binding peptide as an amyloid-specific imaging agent to detect and quantify amyloid in multiple types of systemic amyloidosis and key organs involved by positron emission tomography (PET)/CT imaging.

“Today, the diagnosis of ATTR is a challenging process for patients, with many going years without an accurate diagnosis, and losing critical time in the process,” a company release says. “There is a significant unmet need, and the development of an amyloidosis specific diagnostic has the potential to transform the diagnosis process for ATTR amyloidosis patients and allow patients to get onto treatment sooner.”

In initial clinical trials, AT-01 was shown to detect multiple types of amyloid deposits, including AL and ATTR, in major organs such as the heart, kidney, liver and spleen, the company says. A Phase 1/2 trial, conducted by the University of Tennessee Medical Center, evaluated the ability of the imaging agent to detect amyloid deposits by PET/CT imaging in patients with diverse forms of systemic amyloidosis, including ATTR.

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