Drugs

Viiv Healthcare Gets ‘Complete Response’ on HIV NDA

FDA has issued ViiV Healthcare a complete response letter on its NDA for cabotegravir and rilpivirine, a long-acting regimen for treating HIV-1 infection in virologically suppressed adults. The letter cited chemistry manufacturing and controls (CMC) concerns as the reason for not approving the submission, the company says. “There have been no reported safety issues related to CMC and there is no change to the safety profile of the products used in clinical trials to date,” it says. ViiV expects to meet with FDA soon to determine the next steps for the NDA.

Viiv describes cabotegravir as an integrase strand transfer inhibitor developed by the company and rilpivirine is a non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences Ireland. The combination regimen is not approved anywhere in the world, it adds.

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