Drugs

Genentech Breakthrough Status for Lupus Nephritis Drug

FDA has granted Genentech a breakthrough therapy designation for Gazyva (obinutuzumab) for adults with lupus nephritis. This designation was based on data from the Phase 2 NOBILITY study in adult patients with proliferative lupus nephritis which showed Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), “demonstrated enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year,” the company says. A Phase 3 study is being planned and enrollment should begin next year.

Genentech says that Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. It is believed to work by attacking targeted cells both directly and together with the body’s immune system. The therapy is part of a collaboration between Genentech and Biogen. Combination studies evaluating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across several blood cancers.

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