Drugs

Zymedi Gets Orphan Status for ZMA001

FDA has granted Zymedi an orphan drug designation for ZMA001, a proposed first-in-class antibody treatment in development for pulmonary arterial hypertension (PAH), an inflammatory vascular disease that the company says is characterized by the remodeling and narrowing of pulmonary arterioles due to various causes. “The infiltration of immune cells from the blood into the lungs damages the pulmonary system, increases pulmonary arterial pressure, and ultimately leads to right ventricular failure and death, with a survival rate comparable to cancer,” Zymedi says. Currently, most treatments involve vasodilators, which alleviate symptoms without curing the condition, it says.

ZMA001 is described as a human monoclonal antibody that blocks the infiltration of inflammation-inducing macrophages into the lungs, thus inhibiting the symptoms of PAH from the early stages. “Notably, ZMA001 has shown a synergistic effect when used in conjunction with existing medications, positioning it as a potential game-changer in PAH treatment, where innovative drugs are urgently needed,” Zymedi says.

ZMA001 is currently undergoing a Phase 1a clinical trial at NIH that began in January to evaluate the drug’s safety/tolerability and to determine the appropriate dosages and identify any potential side effects, according to the company.

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