Drugs

pSivida Files NDA for Eye Disease

pSivida Corp. has submitted an NDA for Durasert, a three-year sustained-release implant containing the corticosteroid fluocinolone acetonide for treating posterior segment uveitis. The submission includes data from two Phase 3 studies that achieved the primary efficacy endpoint, according to the company. The most recent study reported last year involved 153 patients and the primary endpoint was prevention of recurrence of posterior uveitis at six months with patients continuing to be followed for 36 months. The product “demonstrated a significant reduction in the recurrence of posterior segment uveitis through six months; 21.8% of Durasert-treated patients had a recurrence compared to 53.8% of patients in the sham group (p < 0.001).” pSivida says.

Posterior segment uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye and often involving the retina. It affects people of all ages and can destroy eye tissues, leading to severe vision loss and blindness. In the U.S., posterior uveitis affects between 80,000 and 100,000 people, the company says.

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