Drugs

Sanofi Gains Approval for Kidney Transplant Rejection Therapy

FDA has approved Sanofi’s Thymoglobulin [anti-thymocyte globulin (rabbit)], for use in conjunction with concomitant immunosuppression to prevent acute rejection in patients receiving a kidney transplant. Approval was based on data from two randomized multicenter studies comparing Thymoglobulin to interleukin-2 receptor antagonists (il2ra:basiliximab or daclizumab) in deceased donor kidney transplant recipients. “The first study in kidney transplant patients (n=278) at increased risk of acute rejection or delayed graft function showed a significantly lower incidence of the treatment failure as measured by a composite endpoint (biopsy-proven acute rejection, graft loss, death or lost to follow-up) within 12 months following transplantation in the Thymoglobulin group compared to patients in the basiliximab group (25% versus 38%; p=0.02),” the company says.

The second study was an investigator-sponsored study in 230 kidney transplant patients who were at high immunological risk for rejection. Patients received either Thymoglobulin or daclizumab and also showed a lower incidence of treatment failure as measured by the composite endpoint 12 months following transplantation (25% versus 34%), Sanofi 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

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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