Drugs

Skyrizi Better Than Stelara: AbbVie Data

AbbVie is reporting “positive results” from the head-to-head Phase 3 SEQUENCE study that evaluated the efficacy and safety of its Skyrizi (risankizumab) 600 mg intravenous [IV] drug compared to Janssen’s Stelara (ustekinumab) 600 mg IV in patients with moderately to severely active Crohn’s disease who have failed one or more anti-TNFs.

According to the company, Skyrizi met both primary endpoints of non-inferiority for clinical remission (Crohn's Disease Activity Index) at Week 24 and superiority of endoscopic remission at Week 48 versus Stelara. Skyrizi also showed superiority versus Stelar for all ranked secondary endpoints, including achievement of clinical remission at Week 48, achievement of endoscopic response at Week 48 and 24, achievement of steroid-free endoscopic remission at Week 48 and achievement of steroid-free clinical remission at Week 48. “Safety results were consistent with the overall safety profile of risankizumab, with no new safety risks identified,” AbbVie 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