Drugs

J&J Reports Positive Data in Psoriasis Drug

Johnson & Johnson says data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies showed that its experimental psoriasis drug icotrokinra outperformed Bristol Myers Squibb’s oral therapy deucravacitinib in patients with moderate-to-severe plaque psoriasis.Pesented at the European Academy of Dermatology and Venereology (EADV) Congress, the data also demonstrated that icotrokinra achieved higher rates of complete skin clearance at weeks 16 and 24 while maintaining a safety profile similar to placebo, it says. Adverse events were numerically lower compared with deucravacitinib, and no new safety signals were identified.

In addition, J&J reported new 52-week results from its ICONIC-LEAD trial that evaluated icotrokinra in both adults and adolescents. Among adults who had already responded to treatment by week 24, 84% maintained their response at week 52 compared to 21% of those who switched to placebo, it says. In adolescents, 86% of patients who received icotrokinra continuously for a year achieved strong clearance rates, along with 77% of those who switched from placebo at week 16.

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