Drugs

Priority Review for ViiV’s Cabotegravir HIV Preventer

FDA has granted priority review for ViiV Healthcare’s NDA for investigational, injectable cabotegravir long-acting for pre-exposure prophylaxis for preventing HIV. The company says the drug already received breakthrough therapy designation from FDA. The agency set a PDUFA target action date of 1/24/22.

ViiV says the NDA is based on the results from two Phase 2b/3 studies that evaluated the safety and efficacy of cabotegravir long-acting for pre-exposure prophylaxis in men who have sex with men, transgender women, and cisgender women. The blinded, randomized portions of both studies were stopped early by independent data safety monitoring boards after cabotegravir was shown to be superior to daily oral emtricitabine/tenofovir disoproxil fumarate (Gilead’s Truvada) tablets in preventing the acquisition of HIV.

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