Drugs

GSK Hepatitis B Drug Hits Trial Marks

GSK says its investigational bepirovirsen met the primary endpoints in the B-Well 1 and B-Well 2 pivotal Phase 3 trials evaluating it as a treatment for chronic hepatitis B in over 1,800 patients. A company statement says GSK plans global regulatory filings from the first quarter of 2026.

“The B-Well trials met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate,” the statement says. “Functional cure rates were significantly higher with bepirovirsen plus standard of care (nucleos(t)ide analogues) compared with standard of care alone…. The trials demonstrated an acceptable safety and tolerability profile consistent with what was reported in other studies.”

Bepirovirsen is described as a triple-action investigational antisense oligonucleotide designed to recognize and orchestrate the destruction of the genetic components (RNA) of the hepatitis B virus that can lead to chronic disease, potentially allowing a person’s immune system to regain control. It inhibits the replication of viral DNA in the body, suppresses the level of hepatitis B surface antigen in the blood, and stimulates the immune system to increase the chances of a durable and sustained response, GSK says. The drug has received a fast-track designation from FDA.

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