Biologics

Adicet Wins Fast Track for Lupus Cell Therapy

FDA has granted Adicet Bio a fast-track designation for ADI-001 and its use in treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement. ADI-001 is described as an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for treating autoimmune diseases. Previously, the CAR T cell therapy was granted fast track status for treating relapsed/refractory Class 3 or Class 4 lupus nephritis (LN).

The company says ADI-001 is being advanced across six autoimmune indications. For example, patient enrollment is ongoing in a Phase 1 study evaluating it for treating LN. Patient enrollment in SLE, systemic sclerosis, idiopathic inflammatory myopathy, and stiff person syndrome is expected to be initiated by April, it 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