Drugs

Zasocitinib Beats Sotyktu in Head-to-Head Study: Takeda

Takeda says its zasocitinib significantly outperformed Bristol Myers Squibb’s Sotyktu (deucravacitinib) in the LATITUDE Atlas Phase 3 head-to-head psoriasis study. A Takeda statement says that more than 35% of zasocitinib-treated patients achieved complete skin clearance at week 16, more than 2.5 times the Sotyktu response rate. It says the study also demonstrated statistical superiority over Sotyktu for all key secondary endpoints. The drug was generally well tolerated with a consistent safety and tolerability profile, and no new safety signals were identified, Takeda says.

Zasocitinib (TAK-279) is described as an investigational, next-generation, highly selective and potent oral TYK2 inhibitor that maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways. Takeda says it is currently studying zasocitinib safety and effectiveness in Phase 3 studies in psoriatic arthritis and Phase 2 studies in Crohn’s disease, ulcerative colitis, vitiligo, and hidradentis suppurativa.

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