Drugs

Promising Insmed Data in Pulmonary Arterial Hypertension

Insmed is reporting positive results from a Phase 2b clinical trial of its once-daily inhaled therapy treprostinil palmitil inhalation powder (TPIP) and its use in treating pulmonary arterial hypertension (PAH). According to the company, the placebo-controlled trial met its primary and all secondary efficacy endpoints. The therapy showed a 35% reduction in pulmonary vascular resistance, a key measure of the disease's impact on blood vessels in the lungs, compared to placebo. TPIP also led to a 35.5 meter improvement in six-minute walk distance, and a 60% reduction in NT-proBNP, a biomarker of cardiac stress, compared to placebo, it says.

The company says TPIP was generally well tolerated, though treatment-emergent adverse events were more common in the TPIP group (88.4%) than in the placebo group (75.8%). Common side effects included cough, headache and fatigue. No deaths were reported.

Insmed plans to begin a Phase 3 study in patients with pulmonary hypertension associated with interstitial lung disease by the end of 2025 and another Phase 3 study in PAH patients in early 2026.

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