Drugs

Janssen Gets Expanded Label for HIV-treating Cabenuva

FDA has approved a Janssen Pharmaceutical expanded label for Cabenuva (rilpivirine and cabotegravir) to be administered every two months for treating HIV-1 in virologically suppressed adults with no history of treatment failure, and with no known or suspected resistance to either rilpivirine or cabotegravir. Cabenuva was approved 1/2021 as a once-monthly, complete regimen for treating HIV-1 infection in adults to replace their current antiretroviral regimen after becoming virologically suppressed. It comprises two separate injectable medicines — Janssen’s rilpivirine extended-release injectable suspension in a single-dose vial and ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial.

Approval was based on data from the global ATLAS-2M Phase 3b trial results, which demonstrated that every-two-month dosing was non-inferior to once-monthly dosing, according to the company. The study also found that rates of virologic suppression, a key secondary endpoint, were similar for once-every-two-months and once-monthly dosing.

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

Read more

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