J&J Innovative Medicine recalls one IMAAVY lot over particulate matter; two trials also update

This week's filings include one ongoing drug recall and updates to two device/drug collaboration trials.

• J&J Innovative Medicine has an ongoing Class II recall (D-0016-2027) for IMAAVY (nipocalimab-aahu) Injection, 300 mg/1.62 mL, citing presence of particulate matter¹ as the reason. The recall covers Lot JNYJ1208, with an expiration date of 10/30/2027, and involves 49 vials distributed in Ohio¹.
• GI Innovation, Inc. registered a Phase 1b/2 trial called "JET-201" (NCT07871435), first posted October 13, 2026, with Janssen Research & Development, LLC listed as collaborator. The study aims to evaluate the safety, tolerability, and preliminary anti-cancer activity of GI-102 in combination with pasritamig in adult men with metastatic castration-resistant prostate cancer (mCRPC) whose cancer has progressed after previous treatment with a novel hormonal therapy (NHT)². The trial is listed as recruiting, with an estimated enrollment of 107 participants².
• Abiomed Inc.'s ongoing study of its Impella 5.5 SmartAssist device, called "INTeGRATE" (NCT06965504), had its registry listing last updated on October 13, 2026; it lists Johnson & Johnson as collaborator. The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock³. The trial is recruiting, with an actual start date of October 2, 2026, and an estimated enrollment of 250 participants³.