Drugs

ViiV Dovato Ad Claims Challenged

The Better Business Bureau’s National Advertising Division (NAD) has sent superiority claims made in ads for ViiV’s HIV drug Dovato (dolutegravir/lamivudine) to FDA and the Federal Trade Commission for review after the company declined to participate in an NAD self-regulatory process on the claims. The NAD says Gilead Sciences, which manufactures the competing HIV drug Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) challenged express and implied health-related claims that Dovato is superior to Biktarvy because it contains less medicine, does not contain tenofovir alafenamide, and is less likely to adversely affect patients’ renal, lipid, and weight profiles.

“ViiV did not submit a substantive response, but instead informed NAD that it would not participate in NAD’s self-regulatory process because it believes FDA is best positioned to assess the appropriateness of these prescription drug claims,” the NAD statement says. NAD said it referred the claims to the agencies for review and possible enforcement action.

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