Drugs

Product Approval Summaries

DEVICES

CapsoVision has obtained 510(k) clearance for the CapsoCam Plus small bowel capsule endoscope system. The device comprises a capsule endoscope, a retrieval kit, a data access system, and software, which work together to provide a “streamlined, patient-friendly examination,” the company says.

FDA clears an EOS Imaging 510(k) to market the kneeEOS software, an online 3D planning product that uses weight-bearing 3D images and data from the EOS system to provide an optimized surgical plan for total knee arthroplasty. “The software makes an initial automatic proposal for the size selection and position of the implant components to facilitate surgical preparation and optimize the alignment in 3D while displaying relevant clinical parameters in real time,” the company says.

DRUGS

Gilead Sciences has gained NDA approval for Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus infection with compensated liver disease. “Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate, TDF) 300mg,” the company says.

FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. Approval was based on data from a randomized trial (CheckMate 141) comparing nivolumab with chemotherapy (cetuximab, methotrexate, or docetaxel) in patients with the condition.

FDA has approved an Amgen supplemental BLA for the expanded use of Enbrel (etanercept) to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis. Approval is based on data from a Phase 3 one-year study and its five-year open-label extension study. “In addition to demonstrating significant efficacy, the adverse events were similar to those seen in previous studies in adults with moderate-to-severe plaque psoriasis,” 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