Biologics

Janssen Biotech sBLA for Stelara in Adolescents

Janssen Biotech has submitted a Supplemental BLA seeking approval of Stelara (ustekinumab) for treating adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. The human monoclonal antibody, which targets interleukin (IL)-12 and IL-23 cytokines, has been approved in the U.S. for treating adults with moderate to severe plaque psoriasis since 2009.

The submission is based on data from a Phase 3 study called CADMUS, which evaluated the efficacy and safety of Stelar in treating of adolescents with moderate to severe plaque psoriasis. “The efficacy and safety profile of Stelara in the CADMUS trial was consistent with the profile of this anti-IL-12/23 monoclonal antibody as previously observed in adult patients receiving Stelara,” 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

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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