Drugs

Tract Therapeutics Cell Therapy for Kidney Transplant Enters Phase 2

FDA has approved a Tract Therapeutics proposed Phase 2 trial to investigate the efficacy and safety of its novel therapy for kidney transplant recipients, which uses a patient’s own cells that are expanded in a laboratory and infused back into the patient after an organ transplant in order to restore immune balance. The current standard of care relies on the “lifetime use of toxic medications which weaken the immune system causing life-threatening effects and eventual rejection of the organ in approximately 50% of the patients receiving a transplant,” the company says. The Phase 2 study will involve 120 subjects and will evaluate the efficacy and safety of a single Treg infusion in kidney transplant recipients, and enrollment should begin in a few months.

The company’s proprietary platform technology uses autologous polyclonally expanded regulatory T-cells that was developed at Northwestern University. Tract says it intends to file for an Orphan Drug Designation for organ transplantation later this year.

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