Drugs

FDA Lifts Clinical Hold on Novartis/Genvec Hearing Loss Trial

FDA has lifted a clinical hold affecting a Novartis/GenVec Phase 1-2 clinical trial of CGF166 in patients with severe to profound hearing loss. In January, Novartis told GenVec that enrollment in the trial had been stopped in accordance with criteria in the trial’s protocol. In April, Novartis informed GenVec that the trial’s Data Safety Monitoring Board recommended that the trial continue after reviewing safety and efficacy data from the nine patients who have been enrolled in the trial to date. New patient enrollment will begin shortly and the trial will be completed sometime in 2017, the companies say.

CGF166 was designed by GenVec to leverage the company’s AdenoVerse technology platform to deliver the atonal gene to sensory cells in the inner ear. “These sensory cells are critical to both hearing and balance and can become damaged or destroyed due to aging, infection, trauma from certain medications, or exposure to noise,” Genvex says. “Preclinical experiments have demonstrated the formation of new inner ear sensory hair cells as well as the restoration of hearing and balance function in animal models following treatment with CGF166.”

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