Drugs

J&J’s Nipocalimab Gets Breakthrough Status

FDA has granted Johnson & Johnson a breakthrough therapy designation for nipocalimab and its use for treating adults living with moderate-to-severe Sjögren's disease (SjD), a debilitating and chronic autoantibody disease. Nipocalimab is said to be the only investigational therapy to win breakthrough status for SjD.

The designation is based on data from the Phase 2 DAHLIAS study evaluating the efficacy and safety of nipocalimab for the treatment of adult patients with moderate-to-severe SjD and “supports further evaluation of the investigational treatment through a Phase 3 study, which is underway,” J&J says. “Data from the nipocalimab Phase 2 DAHLIAS study were featured in a late-breaking oral presentation (LBA0010) at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress and demonstrated the first-ever positive results of an investigational FcRn blocker as a potential targeted therapy in SjD.”

Monoclonal antibody nipocalimab is designed to “bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies, potentially without impact on other immune functions,” the company says.

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