Biologics

Gilead Positive on Twice-Yearly HIV Drug Data

Gilead Sciences says data from an interim analysis from a second pivotal Phase 3 clinical trial investigating its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, showed that it reduced HIV infections by 96% compared to background HIV incidence. “There were two incident cases among 2,180 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group,” the company says. The therapy also demonstrated superiority to Gilead’s once-daily Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg).

In the analysis by an independent data monitoring committee (DMC) confirmed that the PURPOSE 2 trial met its key efficacy endpoints for pre-exposure prophylaxis, Gilead says, adding that the DMC recommended that the trial’s blinded phase end so patients can be offered open-label lenacapavir.

The company says it will soon begin a series of global regulatory filings to launch the twice-yearly HIV prevention therapy in 2025, if approved.

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